Treatment Trials

14 Clinical Trials for Various Conditions

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COMPLETED
Single Port Insufflation RCT
Description

The goal of this clinical trial is to learn if decreasing insufflation pressure during minimally invasive single port robotic sacrocolpopexy improved postoperative pain without impacting surgeon intraoperative visualization. The main question it aims to answer is: Does minimally decreasing insufflation pressure improve postoperative pain? Researchers will compare standard insufflation pressure (15 mmHg) to experimental insufflation pressure (12 mmHg) to see if it insufflation pressure impacts patient's postoperative pain. Once a participants agrees to participate in our study, they will receive either standard or experimental pressure at the time of surgery. Postoperative pain scores in the postoperative anesthesia care unit and at postoperative day 1 and 14 visits will be recorded. Participants will also be asked to complete the Patient Global Impression of Improvement at the 14 day visit.

RECRUITING
Prostate Single Port & Laser Enucleation Comparison Trial
Description

Surgical treatments for benign prostatic hyperplasia (BPH) are necessary when non-procedural approaches fail to alleviate lower urinary tract symptoms (LUTS) or bladder outlet obstruction (BOO). Open simple prostatectomy and laser enucleation are recommended for prostatic adenoma size greater than 80 ml. Minimally invasive approaches, such as robotic-assisted simple prostatectomy, have gained popularity due to their comparable outcomes with lower morbidity. The introduction of the da Vinci single-port (SP) robotic platform offers potential advantages, but its outcomes have not been thoroughly investigated. This randomized controlled trial aims to compare the outcomes of SP simple prostatectomy performed using the da Vinci robotic platform versus thulium laser enucleation of the prostate for the treatment of BPH and BOO.

RECRUITING
The da Vinci Single Port Robotic System for Use in Abdominal and Pelvic Surgical Procedures
Description

This phase II trial test the effectiveness and safety of a single-port robotic device (the da Vinci single port \[SP\]1098) for use in abdominal and pelvic surgeries. The da Vinci SP1098 robotic device can be used to perform less invasive surgeries that allow entry into the body through a single, small incision. The use of this device during surgery may allow surgeons to perform complex procedures that result in less pain, fewer complications and side effects, and improved recovery.

RECRUITING
Single-Port Transvesical Partial Prostatectomy Versus High Intensity Focused Ultrasound
Description

This study aims to compare the novel single-port robotic partial prostatectomy to High-intensity focused ultrasound (HIFU) in patients with low to intermediate risk localized prostate cancer. These interventions have become acceptable focal therapies prevalent with beneficial oncologic outcomes and therefore need to be examined further.

RECRUITING
Evaluation of SINGLE PORT (SP) Robotic Technology in Colorectal Surgery
Description

Currently a multiport robotic surgery platform (Intuitive Xi) is widely available and used for colorectal surgery indications. A Single port platform (Intuitive SP) is FDA approved for Head and Neck and Urology but has not been widely used in colorectal surgery. This study seeks to evaluate the safe and effective use of the SP platform for colorectal surgery indications.

COMPLETED
Prospective Registry Trial for Single Port Robot-assisted Nipple Sparing Mastectomy (SPrNSM)
Description

This is a prospective registry trial to determine the outcomes of single port robot-assisted nipple sparing mastectomy (SPrNSM) utilitzing the SP da Vinci surgical system.

WITHDRAWN
Single-Port Versus Multi-Port Robotic Radical Prostatectomy
Description

The purpose of this study is to compare two different techniques to perform the standard of care surgery to treat prostate cancer. This surgery is called robotic radical prostatectomy. There are two robotic surgical systems approved by the Food and Drug Administration (FDA) to perform this surgery. First system is called the Da Vinci ® Xi system. With this system, six small incisions are made during the surgery. Second system is called the Da Vinci ® SP system. With this system a single incision is made during the surgery. Same surgery is done with each surgical system. This study aims to understand whether a single incision surgery ends up with better recovery after surgery.

UNKNOWN
Feasibility and Safety of Single Port Robot in Colorectal Procedures
Description

The purpose of this study is to evaluate the safety and feasibility of using the Single Port (SP) robot (daVinci, Intuitive Surgical) to perform single port robotic colon surgery and transanal robotic surgery. The hypothesis of the study is that the SP robot will prove a safe effective modality to perform these procedures.

COMPLETED
Robotic Single Port Donor Nephrectomy
Description

Feasibility study on robotic-assisted single-site donor nephrectomy utilizing da Vinci instrumentation and Single-Site platforms.

COMPLETED
A Comparison of Single Port and Four Port Laparoscopic Gallbladder Removal
Description

New minimally invasive surgical treatments are often outpatient procedures with low complication rates, promising fast recovery. The traditional physician-reported outcomes such as complication rates, blood loss, and hospital stay are not useful to guide treatment recommendations for one or the other minimally invasive procedure. This study aims to apply patient-reported outcomes developed within the NIH framework for cancer research and chronic disease treatment to the comparative effectiveness research in minimally invasive procedures for benign disease.

Conditions
WITHDRAWN
Randomized Prospective Trial: Single Port Laparoscopic Vertical Sleeve Gastrectomy Versus Conventional Five Port Laparoscopic Vertical Sleeve Gastrectomy Surgery
Description

Vertical Sleeve Gastrectomy has been shown to significantly reduce weight and has been approved as a treatment of morbid obesity. The standard laparoscopic operation requires five small incisions for the introduction of instruments and the band into the patient's abdomen. The investigators have developed a technique for performing this operation through a single incision at the belly button. This study compares this method to the conventional 5-incision approach.

COMPLETED
A Trial of Single Port Laparoscopic Cholecystectomy Versus Four Port Laparoscopic Cholecystectomy
Description

This is a single-institution, prospective, one-to-one randomized controlled research study. Subjects medically determined to need a cholecystectomy will be consented for surgery and study participation prior to enrolment in this study. Patients will then be randomized to receive either a single port laparoscopic cholecystectomy or a four port laparoscopic cholecystectomy.

UNKNOWN
Consecutive Series Outcomes Review of Patients Undergoing a New Single Portal Technique for Endoscopic Carpal Tunnel Release
Description

The Purpose of this study is to report a new single portal endoscopic release technique and the sequence of the first 50 patients who underwent this release. This will be a chart review of the demographics, outcomes, and complications of a sequential series of patients undergoing a Seg-Way Endoscopic carpal tunnel release (ECTR).

Conditions
RECRUITING
Robotic Vs. Open NSM for Early Stage Breast Cancer
Description

This study evaluates the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.