Treatment Trials

25 Clinical Trials for Various Conditions

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AE05ML Device for ML Hem-o-lok Polymer Clip Delivery in Laparoscopic Surgical Procedures Observational Registery Study
Description

This clinical registry study aims to evaluate the safety and effectiveness of the AE05ML device for ligating vessels and tissue structures during laparoscopic surgery using Hem-o-lok® Medium Large (ML) polymer clips. The primary objective is to assess the device's safety and performance, with secondary objectives focusing on device performance characteristics and operator feedback.

Conditions

Gall Bladder Disease, Bile Duct Diseases, Acute Cholecystitis, Kidney, Liver, Appendix, Spleen Disease, Prostate

Gallbladder Cryoablation in High-Risk Patients
Description

Benign gallbladder disease, including acute cholecystitis, chronic cholecystitis, biliary dyskinesia, and biliary colic, is very common, with over 300,000 surgical cholecystectomies performed per year in the US. Unfortunately, complication rates in elderly patients or patients with many comorbidities are high. These patients are often managed with percutaneous tube drainage of the gallbladder (percutaneous cholecystostomy). The recurrence rate of calculous cholecystitis after cholecystostomy tube removal is as high as 35% at 1 year. These patients are thus faced with permanent cholecystostomy tube drainage, high-risk surgery, or cholecystostomy tube removal and risk of repeat cholecystitis. Gallbladder cryoablation is an alternative to surgical cholecystectomy which is performed percutaneously and does not require general anesthesia. Published evidence on the outcomes of gallbladder cryoablation is however limited at this point in time. The purpose of the proposed study is to follow the outcomes of high-risk patients who undergo gallbladder cryoablation.

Conditions

Gallbladder Diseases, Cholecystitis, Biliary Colic, Gallstone; Cholecystitis, Biliary Dyskinesia, Gallstone, Gall Bladder Pain

Prospective Multicenter Human Randomized Controlled Evaluation of NOTES® Cholecystectomy
Description

This study is designed to be a United States multicenter prospective randomized controlled non-inferiority evaluation of transgastric and transvaginal Natural Orifice Translumenal Endoscopic Surgery (NOTES) cholecystectomy compared to laparoscopic cholecystectomy in elective surgery patients. Up to 200 patients will be enrolled to obtain 70 NOTES cholecystectomies (35 transgastric and 35 transvaginal) and 70 laparoscopic cholecystectomies on a randomized basis. In order to evaluate the hypothesis that NOTES cholecystectomy has equivalent safety and efficacy to laparoscopic cholecystectomy, clinical and administrative outcomes will be measured.

Conditions

Gall Bladder Diseases

Operating Room Outcomes After Resident Training on a Virtual Reality Simulator
Description

The purpose of this study is to compare outcomes of patients undergoing laparoscopic cholecystectomy before and after a laparoscopic training curriculum was implemented.

Conditions

Gall Bladder Disease

Using Data to Achieve Surgical Health Equity in the Community
Description

The goal of this retrospective cohort and pragmatic pilot trial is to examine the social determinants of health in racial and ethnic minority patients from socially vulnerable backgrounds who have Gallbladder Disease (GBD). The main questions it aims to answer are: 1. What racial barriers in outcome exist for socially vulnerable patients with gallbladder disease? 2. How effective is telemedicine consultation in improving surgical outcomes for socially vulnerable patients with gallbladder disease? Study participants will be asked to undergo telemedicine consultation in place of regular consultation with their doctor before undergoing treatment. Researchers will compare the telemedicine consultation groups with traditional care patients to see if telemedicine consultation is effective at reducing surgical disparity outcomes.

Conditions

Gallbladder Disease

Comparing the Outcomes of Laparoscopic Cholecystectomy vs. Robotic Cholecystectomy
Description

This research is being done to examine which minimally invasive surgical approach is associated with the best outcomes when performing cholecystectomy surgery: laparoscopic or robotic? Laparoscopic and robotic approaches are similar surgical procedures using small incisions. The laparoscopic approach is largely used for the removal of the gallbladder (cholecystectomy). At UIC, the investigators perform the majority of the gallbladder surgeries through the robotic approach and only a few using the laparoscopic approach. The robotic surgical tools allows the surgeon the same freedom of movement as a human wrist, while using a 3D camera view. The laparoscopic and robotic surgical approaches both represent minimally invasive surgery approach and are associated with less pain, faster recovery and better cosmetic outcomes when compared to traditional open surgery. It is not currently known which approach is better.

Conditions

Gallbladder Diseases

Effect IV Ibuprofen and Inflammatory Responses
Description

This study is being done because the investigators wish to study ways to improve recovery after surgery. Injury, including surgical injury, causes inflammation. Inflammation is the body's attempt to protect itself and to start the healing process. Some surgical complications are related to the body's natural inflammatory response. Although mainly a healing response, inflammation can also have side effects which delay recovery. The investigators wish to determine the effect of a medication known as ibuprofen on recovery. You may know ibuprofen by the name Advil or Motrin. The medication will be given through the vein prior to the start of the surgery. Three blood samples will be taken, two while the patient is under anesthesia. The subject will be asked to complete several questionnaires.

Conditions

Gallbladder Disease

Cosmesis, Patient Satisfaction and Quality of Life After da Vinci Single Site and Multiport Laparoscopic Cholecystectomy
Description

Prospective, randomized , multicenter study comparing cholecystectomy performed with da Vinci Single Site Instruments™ to multi-port (four ports) laparoscopy

Conditions

Symptomatic Gallbladder Disease

A Trial to Evaluate Natural Orifice Transvaginal Endoscopic Cholecystectomy With Laparoscopic Assistance
Description

The study will document being able to successfully remove a subject's gallbladder through the vagina (laparoscopic visualization)using a small collection of study surgical tools.

Conditions

Gallbladder Disease

SILS™ Port Laparoscopic Cholecystectomy Post Market Study
Description

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.

Conditions

Gallbladder Disease

Prospective Evaluation of Idiopathic Pancreatitis: Role of Endoscopic Ultrasonography
Description

The purpose of the study is to determine the best evaluation for patients with idiopathic (unexplained) pancreatitis.

Conditions

Gallbladder Disease, Pancreatitis

Emergency Ultrasound of the Gallbladder
Description

The purpose of this study is to determine whether fasting for 8 hours prior to ultrasonography for cholelithiasis (gallbladder pain) is needed.

Conditions

Gallbladder Diseases

Seattle Spatial Transcriptomic Research in Inflammatory Bowel Disease Evaluation (STRIDE)
Description

This is a prospective observational study collecting long-term clinical data and samples for research in pediatric inflammatory bowel disease (IBD) patients with gut inflammation and a control cohort of pediatric patients with disorders of the brain-gut interactions (DBGI) with no detectable gut inflammation.

Conditions

Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis, Indeterminate Colitis, Functional Abdominal Pain Syndrome, Functional Bowel Disorder, Esophageal Diseases, Gastroduodenal Disorder, Bowel Dysfunction, Gallbladder Diseases, Sphincter of Oddi Dysfunction, Anorectal Disorder

GATT-Patch Versus SURGICEL® Original in Minimally Invasive Liver and Gallbladder Surgery
Description

This is a pre-market, prospective, randomized (1:1), multicenter, pivotal clinical investigation. The purpose of this investigation is to determine the clinical performance of GATT-Patch as compared with SURGICEL® Original for the management of minimal, mild, or moderate bleeding during minimally invasive liver and gallbladder surgery.

Conditions

Intraoperative Bleeding, Liver Diseases, Gallbladder Diseases, Hemorrhage, Surgical

Single Agent Regorafenib in Refractory Advanced Biliary Cancers
Description

The main purpose of this study is to see if regorafenib can help control or decrease cancer size in patients with cancer of the bile duct. Researchers also want to find out if regorafenib is safe and tolerable.

Conditions

Cancer of the Bile Duct

EUS-Guided Rendezvous or Direct Interventions Versus Advanced ERCP Techniques for Biliary Access and Therapy
Description

The purpose of this study is to prospectively compare the efficacy of endoscopic ultrasound-guided biliary interventions (EUS-rendezvous or direct EUS-guided therapy) to that of advanced ERCP cannulation techniques in the setting of difficult cannulation. We hypothesize that EUS-guided interventions will be more successful and may be associated with the same complications as using advanced ERCP techniques in cases of difficult bile duct access.

Conditions

Disorders of Gallbladder, Disorders of Biliary Tract

A Prospective, Single-Center Investigation of the da Vinci SP® Surgical System in Hepatopancreaticobiliary and Foregut Operations for Benign and Malignant Disease
Description

The purpose of this study is to collect data to evaluate safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in hepatopancreatic biliary (HPB) and Foregut operations. HPB and Foregut operations of this study consist of cholecystectomy, fundoplication, gastrectomy, distal pancreatectomy, pancreaticoduodenectomy, esophagectomy, and hepatectomy.

Conditions

Hepatopancreaticobiliary and Foregut Operations

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

CHOLELITHIASIS

Ultrasound for Diagnosis of Biliary Dyskinesia
Description

This is a prospective, non-randomized study of 50 people with suspected biliary dyskinesia. The purpose of this study is to investigate if it is possible to use ultrasound to make a diagnosis of a condition called biliary dyskinesia. The investigators null hypothesis is that there will be no statistical difference between the proposed experimental test (Ultrasound) and the HIDA scan (a nuclear medicine hepatobiliary system scan) in the diagnosis of biliary dyskinesia.

Conditions

Biliary Dyskinesia

A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors
Description

This is a Phase 1 study to assess the safety and efficacy of ELI-002 immunotherapy (a lipid-conjugated immune-stimulatory oligonucleotide \[Amph-CpG-7909\] plus a mixture of lipid-conjugated peptide-based antigens \[Amph-Peptides\]) as adjuvant treatment of minimal residual disease (MRD) in subjects with KRAS/neuroblastoma ras viral oncogene homolog (NRAS) mutated PDAC or other solid tumors.

Conditions

Minimal Residual Disease, KRAS G12D, KRAS G12R, NRAS G12D, NRAS G12R, Pancreatic Ductal Adenocarcinoma, Colorectal Cancer, Non-small Cell Lung Cancer, Ovarian Cancer, Cholangiocarcinoma, Bile Duct Cancer, Gallbladder Carcinoma

Copanlisib (BAY 80-6946) in Combination With Gemcitabine and Cisplatin in Advanced Cholangiocarcinoma
Description

The purpose of this study is to see if an experimental drug, called copanlisib is effective and safe in treating adult participants with cholangiocarcinoma, when used in combination with gemcitabine and cisplatin.

Conditions

Biliary Carcinoma, Gall Bladder Carcinoma, Cholangiocarcinoma, Gastrointestinal Tumor

B-Receptor Signaling in Cardiomyopathy
Description

We hope to determine the importance of different genes (including B receptors) in anthracycline-induced cardiomyopathy. This has important benefits to patients exposed to anthracyclines, as this could help determine whether certain individuals have increased susceptibility to cardiac injury.

Conditions

Carcinomas, Amyloidosis, Anal Cancer, Anemia, Cholangiocarcinoma of the Extrahepatic Bile Duct, Transitional Cell Carcinoma of Bladder, Bone Marrow Transplant Failure, Bone Cancer, Cancer of Brain and Nervous System, Breast Cancer, Carcinoma of the Large Intestine, Endocrine Cancer, Esophageal Cancer, Eye Cancer, Gall Bladder Cancer, Gastric (Stomach) Cancer, Gastrooesophageal Cancer, Gastrointestinal Stromal Tumor (GIST), Gynecologic Cancers, Head and Neck Cancers, Hepatobiliary Neoplasm, Kidney (Renal Cell) Cancer, Leukemia, Lung Cancer, Hodgkin Disease, Lymphoma, Non-Hodgkin, Mesothelioma, Multiple Myeloma, Myelodysplastic Syndromes (MDS), Neuroendocrine Tumors, Myeloproliferative Disorders, Pancreatic Cancer, Prostate Cancer, Skin Cancer, Soft Tissue Sarcoma, Testicular Cancer, Thymus Cancer, Thyroid Cancer

Vaccine Therapy With or Without Sargramostim in Treating Patients With Advanced or Metastatic Cancer
Description

Phase I trial to study the effectiveness of vaccine therapy with or without sargramostim in treating patients who have advanced or metastatic cancer. Vaccines may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may make tumor cells more sensitive to the vaccine and may kill more tumor cells

Conditions

Adenocarcinoma of the Colon, Adenocarcinoma of the Gallbladder, Adenocarcinoma of the Pancreas, Adenocarcinoma of the Rectum, Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer, Cholangiocarcinoma of the Gallbladder, Diffuse Adenocarcinoma of the Stomach, Intestinal Adenocarcinoma of the Stomach, Male Breast Cancer, Mixed Adenocarcinoma of the Stomach, Ovarian Endometrioid Adenocarcinoma, Paget Disease of the Breast With Intraductal Carcinoma, Paget Disease of the Breast With Invasive Ductal Carcinoma, Recurrent Adult Primary Liver Cancer, Recurrent Breast Cancer, Recurrent Colon Cancer, Recurrent Gallbladder Cancer, Recurrent Gastric Cancer, Recurrent Malignant Testicular Germ Cell Tumor, Recurrent Pancreatic Cancer, Recurrent Rectal Cancer, Recurrent Salivary Gland Cancer, Salivary Gland Adenocarcinoma, Stage II Malignant Testicular Germ Cell Tumor, Stage II Pancreatic Cancer, Stage III Colon Cancer, Stage III Gastric Cancer, Stage III Malignant Testicular Germ Cell Tumor, Stage III Pancreatic Cancer, Stage III Rectal Cancer, Stage III Salivary Gland Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IV Breast Cancer, Stage IV Colon Cancer, Stage IV Gastric Cancer, Stage IV Pancreatic Cancer, Stage IV Rectal Cancer, Stage IV Salivary Gland Cancer, Thyroid Gland Medullary Carcinoma, Unresectable Gallbladder Cancer

Vaccine Therapy in Treating Patients With Advanced or Metastatic Cancer
Description

RATIONALE: Vaccines made from a person's white blood cells that have been treated in the laboratory may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have advanced or metastatic cancer.

Conditions

Breast Cancer, Colorectal Cancer, Gallbladder Cancer, Gastric Cancer, Head and Neck Cancer, Liver Cancer, Ovarian Cancer, Pancreatic Cancer, Testicular Germ Cell Tumor

Biological Therapy in Treating Patients With Metastatic Cancer
Description

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. PURPOSE: Phase I trial to study the effectiveness of biological therapy in treating patients who have metastatic cancer that has not responded to previous treatment.

Conditions

Breast Cancer, Colorectal Cancer, Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Gastric Cancer, Head and Neck Cancer, Liver Cancer, Lung Cancer, Metastatic Cancer, Ovarian Cancer, Pancreatic Cancer, Testicular Germ Cell Tumor