126 Clinical Trials for Various Conditions
The goal of this observational study is to better understand the learning curve among novice glaucoma surgeons performing Hydrus microstent insertion. The main question it aims to answer is what is the average number of cases does it take new glaucoma surgical fellows to become competent in Hydrus insertion. Researchers will review and grade videos of surgical cases. Participating fellows will complete a survey reporting the number of cases they had completed before beginning their glaucoma surgical fellowship and how many Hydrus cases they performed during their fellowship before they felt comfortable performing Hydrus cases without an attending surgeon overseeing their work.
The objectives of this trial are: 1. to assess the feasibility and safety of performing SILS™ Port Laparoscopic Cholecystectomy 2. monitor and compare the outcomes of SILS™ Port Laparoscopic Cholecystectomy versus 4PLC to objectively document the scientific merit and the perceived advantages of SILS™ Port Laparoscopic Cholecystectomy.
This research is being done to compare two methods of surgery to treat scoliosis and/or kyphosis of the spine.
Blood clotting abnormalities or problems that happen during surgery ? even minor surgery ? are serious because of the possibility of serious bleeding that cannot be stopped. The current standard practice for people with clotting abnormalities is to transfuse additional blood before the surgery, in an effort to decrease bleeding problems. However, transfusing blood before the surgery is not very effective in decreasing bleeding complications. In addition, it may be associated with other complications, including fluid buildup and swelling in the lungs. For this study, a person with a mild clotting problem is defined as one with an INR (International Normalized Ratio) between 1.5 and 3. Severe clotting is defined as an INR greater than 3. This study will aim to test if limiting or restricting transfusion for those patients with severe clotting problems (an INR greater than 3) will result in fewer transfusion problems and fewer unnecessary transfusions in comparison with the current, more liberal, transfusion use for all patients with both mild and severe clotting problems (an INR greater than 1.5).The investigators will also determine if liberal blood transfusion decreases the risk of bleeding after surgical procedures.
The purpose of this study is to determine if there is a better method of administering pain medication prior to minimally invasive gynecological surgery so that postoperative pain and/or narcotic usage may be minimized. Currently, no standard of care exists regarding the use of local pain medications in minimally invasive gynecological surgery and practices vary widely among physicians, even within the same institution. The two methods of preemptive pain medication that this study will be looking at is the transversus abdominis plane (TAP) block and the local injection of pain medication at the areas of the skin incisions. TAP block is a procedure performed by a specially trained pain management anesthesiologist in which there is an injection of a local pain medication into the abdominal wall, specifically in a space where the nerves that are responsible for postoperative pain reside. This procedure blocks the ability of the nerves to sense pain and has been found to be successful in decreasing postoperative pain in a number of procedures. The local injection of pain medications at the incision sites has also been found to be beneficial in decreasing postoperative pain. However, it is not known whether one method is superior to the other in decreasing postoperative pain or if the combination of both is best. Patients that chose to participate are randomly (by chance) assigned to one of three groups: 1) TAP block with pain medication and local injection of normal saline (water) at the incision sites 2) TAP block with normal saline and local injection of pain medication at the incision sites or 3) TAP block with pain medication and local injection of pain medication at the port sites. These procedures are performed while the patient is asleep. Patients will be asked to record their level of pain on a standardized pain scale at one hour, six hours, and twenty-four hours after the surgery. All patients are provided with standard postoperative pain medications as needed. The hypothesis is that patients receiving both TAP block and local injection of pain medication at the port sites will have less pain postoperatively and require a smaller amount of narcotics than those that receive either the TAP block or local injection of pain medication alone.
This is a prospective randomized clinical trial with the study cohort comprised of all male and female patients over the age of 21 presenting to the study site for evaluation of lung cancer. The study will enroll 300 subjects, with 150 in each arm. Three sites will be in the study, Mayo Rochester, Mayo Jacksonville and Medical University of South Carolina. Mayo Rochester will enroll approximately 125 subjects. This study does not require subjects to undergo any additional procedures than what they would receive per standard medical care. The consenting subjects will receive EUS and /or EBUS- guided FNA or Mediastinoscopy/Thoracoscopy.
The purpose of this clinical trial is to study the safety and efficacy of an investigational imaging agent for delineation/visualization of urologic anatomy in the setting of minimally invasive surgery.
Aim: To compare the postoperative outcomes after surgical infiltration with plain bupivacaine compared to liposomal bupivacaine in patients undergoing elective, minimally invasive, general surgery procedures. To the investigators knowledge, there are no head-to-head, prospective, randomized, controlled trials of plain bupivacaine versus liposomal bupivacaine to evaluate postoperative pain and return of function.
The primary purpose of the study is to establish the degree and duration of pain relief following minimally invasive surgery for a painful degenerative disc.
The Minimally Invasive Surgery Team (MIST) are establishing a separate research database to find out more about patient's undergoing minimally invasive surgery (laparoscopic , open and robot assisted) procedures at UCSD. The hope is that collection of this information will give physicians a better knowledge and understanding of the benefits of minimally invasive surgery and possibly assist physicians to better manage future patients.
The goal of this pilot study is to learn if a class and hands-on-practice of ergonomic body positions - or specific ways to move the body while working to prevent injury - is valuable to training obstetrics and gynecology doctors. The main questions the study team aims to answer are: * Will these lessons successfully teach the participants how to move bodies at work in a way that will prevent injury? * Will the participants feel that learning and practicing such lessons helps to avoid injury while at work? Researchers will compare training obstetrics and gynecology doctors that attend a class on ergonomics and have guided hands-on-practice of ergonomic body positions with training obstetrics and gynecology doctors that attend the class only to see if the first group learns and remembers how to move their bodies safely while working. All participants will attend a class that teaches basic ergonomic lessons before they are divided into two groups. Group 1 will practice common surgery skills on a model while being videotaped by an artificial intelligence application. The application will make a report on unsafe positions a participant does while practicing surgical skills. The Group 1 participant will then go over the report with one of the study supervisors to talk about ways that the participant can move safely while practicing the skills. The participant will then practice the skills one more time while being videotaped. The study supervisors will then compare the two reports to see if the participant improved. Group 2 will also practice common surgery skills on a model while being videotaped. Group 2 participants will not get to see the report that the application generates or speak with the study supervisors about ways to move safely while practicing the skills. There will be a follow up after two months to see if participants remembered what was learned during the class and during the hands-on practice lesson. All participants will again be videotaped. The study supervisors will compare the videos and reports from the last class to the most recent ones to see if the participants learned and remember how to move safely while working. Participants in both groups will take a quiz about the lessons learned in the class before and after the class to determine what had been learned from the lesson. A survey about how useful and helpful the class was and hands-on practice sessions were will also be completed.
The primary objective of this study is to evaluate the safety and efficacy of the Zip-stitch® Vaginal Cuff Closure System. This will be primarily done by measuring the frequency of implant passing following system use. Also assessed will be relevant safety and efficacy endpoints as compared to a two-to-one reference group.
Evaluate surgical treatment outcomes and identify best practice guidelines for complex adult spinal deformity (ASD) patients treated with minimally invasive approach, including radiographic and clinical outcomes, surgical and postoperative complications, risk factors for and revision surgery rates, and the role of standard work to improve patient outcomes and reduce surgical and postoperative complications.
This is a prospective, multi-center, randomized non-inferiority phase III study to evaluate if patients undergoing a minimally invasive surgery for early stage uterine cancer have cancer cells in the fluid that is obtained at the time of their surgery when a uterine manipulator is placed versus patients who do not have a uterine manipulator placed.
This phase III trial compares minimally invasive surgery (MIS) to laparotomy in treating patients with stage IIIC-IV ovarian, primary peritoneal, or fallopian tube cancer who are receiving chemotherapy before and after surgery (neoadjuvant chemotherapy). MIS is a surgical procedure that uses small incision(s) and is intended to produce minimal blood loss and pain for the patient. Laparotomy is a surgical procedure which allows the doctors to remove some or all of the tumor and check if the disease has spread to other organs in the body. MIS may work the same or better than standard laparotomy after chemotherapy in prolonging the return of the disease and/or improving quality of life after surgery.
Background: A germline mutation is a change to a person s genes that is carried through their DNA. These mutations can be passed on from parents to their offspring. Germline mutations in a gene called BAP1 are linked to the development of mesothelioma and other cancers. Researchers want to follow people with these mutations to learn more. Objective: To see if researchers can improve how people who have or are suspected to have a BAP1 mutation are monitored over time. Eligibility: People age 30 and older who are suspected to have a BAP1 germline mutation. Design: Participants will be screened with a personal and family medical history. Their medical records may be reviewed. They will give a blood or saliva sample to test for a BAP1 mutation. They will get genetic counseling. To take part in this study, participants will enroll on 2 to 3 other protocols. Participants will have a physical exam. They may have a tumor biopsy. They will give blood and urine samples. They will have skin and eye exams. Some participants will have video-assisted thoracoscopy to examine the chest and lungs and diagnose suspicious areas. For this, a small camera is inserted into the chest through a small incision. Some participants will have laparoscopy to examine the organs inside the abdomen. For this, a small camera is inserted into the abdomen through a small incision. Participants will have imaging scans of the chest, abdomen, and pelvis. They may have brain scans. Participants will visit the NIH once a year for follow-up exams. Participation lasts indefinitely.
The objective of this study is to test the technical feasibility of LapAR visualization system for guiding laparoscopic surgeries and to gather clinical feedback on the use of this tool.
SALLY studies sacroiliac joint fusion with the iFuse-3D implant.
The purpose of this study is to examine the psychological and psychosocial impact of surgical scars after minimally invasive surgery (MIS). 100 adult patients who are about to undergo bariatric procedures through the Duke Metabolic \& Weight Loss Surgery program will be enrolled in this study. 50 patients will be randomly assigned to standard laparoscopic surgery and 50 will be assigned to the percutaneous group. All patients will complete pre-operative psychometric testing to establish a baseline body-image score as well as a patient's initial subjective perceptions around surgery and surgical scars. Follow-up visits will be done at standard of care timepoints - 3 weeks, 3 and 6 months, and 1 year after surgery. Subjects will complete the same psychometric measures to identify differences in psychological and psychosocial responses to standard laparoscopic and percutaneous scars. Patients will also complete a measure on scar satisfaction. The investigators hope to identify any differences between standard laparoscopic versus percutaneous approaches.
The aim of this controlled study is to assess the clinical outcomes and patient reported outcomes of using minimally invasive surgical procedure with Straumann Emdogain as an adjunct (test treatment) or without Straumann Emdogain (control treatment).
The purpose of this study is to collect information on the effect of minimally invasive spine tumor decompression on treated patients. This treatment option is less invasive that the standard surgical decompression and is expected to result in better wound healing, decreased tissue trauma, and decreased pain after surgery.
Prospective, randomized controlled trial comparing Endoscopic Ultrasound (EUS) Guided cystogastrostomy or cystoduodenostomy and endoscopic necrosectomy to minimally invasive surgical necrosectomy, in patients with necrotizing pancreatitis.
A phase III, randomized, case-controlled, open-label, 500-subject clinical trial of minimally invasive surgery plus rt-PA in the treatment of intracerebral hemorrhage (ICH).
Hallux valgus is a common deformity of the big toe, defined as medial deviation of the first metatarsal bone along with lateral deviation of the first toe. Surgery has been shown to be beneficial when compared to orthotics or no treatment. While generally effective, surgery is associated with significant post-operative pain and disability, with several weeks of limited mobility. Minimally invasive techniques have the potential to lead to increased patient satisfaction while still achieving adequate correction of the deformity. This trial is a non-inferiority treatment study, with open-label, randomized, prospective, controlled, parallel experimental design, to compare the clinical and radiographic outcomes of a minimally invasive surgery versus a conventional surgery for hallux valgus. This trial examines two different surgical interventions. No drug or device is being evaluated in this trial. 60 to 100 patients, over the age of 18 years, undergoing surgical correction of mild to moderate hallux valgus will be enrolled in the trial. The patients will be randomized to two groups, one treated with a conventional distal osteotomy surgery, the other treated with a minimally invasive surgery. Randomization will occur immediately prior to surgery via a multitude of opaque envelopes containing a coded group assignment. Due to the differences in the techniques, neither the investigator and the subject can be effectively blinded to the group assignment. Data collection for the outcomes measures will occur preop, and then post of at 2 weeks, 12 weeks, and at 1,2, and 3 years. The primary outcomes measure is the Manchester-Oxford Foot Questionnaire Score (MOXFQ). Manchester-Oxford Foot Questionnaire' (MOXFQ), a 16 item patient-reported questionnaire consisting of three domains/scales: 'Walking/standing' (seven items), 'Pain' (five items) and 'Social interaction' (four items). The MOXFQ is a validated disease-specific outcomes scale for foot and ankle surgery which has been shown to be responsive and reliable. Secondary outcome measures are preoperative to postoperative change in hallux valgus angle (HVA). Radiographic outcomes parameters will be measured using weight-bearing radiographs to analyze preoperative and postoperative hallux valgus angle, and the correction or normalization thereof. (Degrees of correction = 2 week preoperative HVA - 12 week postoperative HVA.)
The hypothesis of the proposed study is that performing total knee arthroplasty through a mini subvastus approach results in statistically significant differences in one or more of the above functional outcome measures, when compared in a blinded, prospective, controlled, randomized manner to mini-medial arthrotomy approach. 1. Analyses of lower extremity functional activities (gait and stairs) 2. Strength of thigh musculature 3. Self-assessment of the functional outcomes 4. Return to the activities of daily living and sports activities
The purpose of this study is to compare a minimally invasive surgical procedure and medication management in stroke patients with Atrial Fibrillation. The two treatment options are a minimally invasive surgical procedure or the use of medications.
This randomized clinical trial studies minimally invasive surgery in treating patients with spinal tumors. Posterior spinal tumor resection and anterior and posterior spinal tumor resection are less invasive types of surgery for spinal tumors and may have fewer side effects and improve recovery
The purpose of this study is to assess the efficacy of minimally invasive surgery for atrial fibrillation.
This is an observational study of pain and outcomes from patients undergoing transgastric NOTES removal of their appendix or gallbladder. Subjects who elect to have a transgastric NOTES removal of their appendix or gallbladder and agree to be in this study (through signature on the informed consent form) will be followed per standard of care, with additional follow-up for data collection including the following: * Subjects will complete a 7 day pain/temperature log after surgery * Subjects will receive a phone call at 6 months and at 1 year after surgery to capture data related to safety, adverse events, hospitalizations and patient satisfaction Additional data related to pain and outcomes will be collected at baseline/screening and at follow-up as necessary.
This is an observational study of pain and outcomes from females undergoing transvaginal NOTES removal of their appendix or gallbladder. Female subjects who elect to have a transvaginal NOTES removal of their appendix or gallbladder and agree to be in this study (through signature on the informed consent form) will be followed per standard of care, with additional follow-up for data collection including the following: * Subjects will complete a 7 day pain/temperature log after surgery * Subjects will complete a standardized sexual function questionnaire (Female Sexual Function Index) prior to surgery and 6 months after surgery * Subjects will receive a phone call at 6 months and at 1 year after surgery to capture data related to safety, adverse events, hospitalizations and patient satisfaction Additional data related to pain and outcomes will be collected at baseline/screening and at follow-up as necessary.