Clinical trials: Gastro Intestinal Surgery
Fecal Incontinence
Safety and Performance of a Silicone Implant for Fecal Incontinence Treatment (SimplyFI)
The purpose of the clinical investigation is to verify that the device under investigation (SimplyFI) is appropriate to significantly improve fecal incontinence in patients in whom its use is indicated.
- Trial name
- NCT05708612
- Testing
- Medical Device (SimplyFI)
- Where
- 5 sites in Austria, Germany and 1 more
- Volunteers
- 36 people
- Sponsor
- A.M.I. Agency for Medical Innovations GmbH
Colon Cancer, Rectum Cancer
Phase I of SGM-101 in Patients With Cancer of the Colon, Rectum or Pancreas
This study evaluates the safety and performance of SGM-101, a Carcinoembryonic Antigen (CEA)-specific chimeric antibody conjugated with a NIR emitting fluorochrome, for the visualization of CEA-expressing cancers during surgery.
- Conditions
- Colon Cancer, Rectum Cancer, Pancreas Cancer, Metastatic Colorectal Cancer
- Trial name
- NCT02973672
- Testing
- SGM-101
- Where
- 3 sites in Netherlands
- Volunteers
- 75 people
- Sponsor
- Surgimab
Anastomotic Leaks
Study of Eso-SPONGE for Treating Leaks After Upper Gastrointestinal Surgery
To evaluate the safety and effectiveness of sponge-based Endoscopic Vacuum Therapy (EVT) using Eso-SPONGE for the treatment of anastomotic leaks in the upper gastrointestinal tract in a prospective multi-center study.
- Trial name
- DRAIN Upper (NCT07711093)
- Testing
- sponge-based Endoscopic Vacuum Therapy (EVT) using Eso-SPONGE
- Where
- United States
- Volunteers
- 74 people
- Sponsor
- Boston Scientific Corporation
Gastroesophageal Reflux Disease (GERD)
Medigus Ultrasonic Surgical Endostapler (MUSE) Registry
This registry is intended as an observational, post-marketing surveillance tool. The registry allows collection of baseline demographics and user experience of the commercially available MUSE system.
- Trial name
- NCT02366169
- Testing
- Medigus Ultrasonic Surgical Endostapler (MUSE) Procedure
- Where
- 16 sites in United States, Germany and 1 more
- Volunteers
- 200 people
- Sponsor
- Medigus Ltd
Rectal Neoplasms
Study of Neoadjuvant Chemotherapeutic Treatment (XELOX) Followed by Chemoradiotherapy (XELOX/RT) and Surgery Versus Chemoradiotherapy Followed by Surgery and Chemotherapy in Patients With High Risk Rectal Cancer
Primary: To assess complete pathological response rate of both strategies. Secondary: Safety profile To assess downstaging rate of both strategies.
- Trial name
- NCT00421824
- Testing
- Oxaliplatin, capecitabine
- Where
- Spain
- Volunteers
- 108 people
- Sponsor
- Sanofi
Gastrointestinal Anastomosis
Safety, Tolerability and Performance Profile of the Colospan Device CG-100 in Patients Undergoing Colorectal Surgery
The purpose of this study is to evaluate the CG-100 device, a single use, temporary intraluminal bypass device,intended to reduce contact of fecal content with an anastomotic site, following colorectal surgery (open or…
- Trial name
- NCT02109991
- Testing
- CG-100 device
- Where
- 8 sites in Belgium, Croatia and 2 more
- Volunteers
- 60 people
- Sponsor
- Colospan Ltd.
Lower Abdominal Surgery, Pelvic Surgery
Objective to Evaluate the Safety and Effectiveness of LED Light Source System for Endoscopy in Ureteral Radiography
This clinical trial is a prospective, multi-center, single-blind, parallel, randomized controlled superiority clinical trial. The trial will be carried out in 5 centers, involving 120 subjects as estimated who will be divided…
- Trial name
- IRIS (NCT04561414)
- Testing
- LED light source system for endoscope, Ureteral stent (Cook Ireland Ltd.)
- Where
- 4 sites in China
- Sponsor
- Stryker Orthopaedics
Vaginal Prolapse
Observational Data Collection of Surgical Outcomes in the Treatment of Vaginal Prolapse With AMS Products
This registry was observational (only collected information typically noted by the surgeon when their patients were routinely seen); there was no change to the care the patient received as a result of being part of the registry).
- Trial name
- POWER1012 (NCT00388947)
- Testing
- AMS Prolapse Product
- Where
- United States
- Volunteers
- 1,543 people
- Sponsor
- ASTORA Women's Health
Colonic Neoplasms, Colorectal Neoplasms
Study of an Individualized Vaccine Targeting Neoantigens in Combination With Immune Checkpoint Blockade for Patients With Colon Cancer
The primary objective is to assess and characterize the antitumor activity and safety and tolerability of adjuvant treatment with an individualized neoantigen vaccine called GRT-C901/GRT-R902 (chimpanzee adenovirus [ChAd] and…
- Trial name
- NCT05456165
- Testing
- GRT-C901, GRT-R902, Atezolizumab
- Where
- 3 sites in United States
- Sponsor
- Gritstone bio, Inc.
Colorectal Cancer
A Study of Xeloda (Capecitabine) Compared With 5-Fluorouracil in Combination With Low-Dose Leucovorin in Patients Who Have Undergone Surgery for Colon Cancer
This 2 arm study will compare the safety and efficacy of oral Xeloda, or 5-fluorouracil in combination with leucovorin, in patients who have undergone surgery for colon cancer.
- Trial name
- NCT00009737
- Testing
- 5-Fluorouracil, Leucovorin, Capecitabine [Xeloda]
- Where
- 133 sites in United States, Argentina and 12 more
- Volunteers
- 1,987 people
- Sponsor
- Hoffmann-La Roche
Esophageal Cancer, Gastric Cancer
Nitrocamptothecin in Treating Patients With Locally Advanced or Metastatic Stomach Cancer That Cannot Be Removed During Surgery
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have locally…
- Trial name
- NCT00005876
- Testing
- rubitecan
- Where
- United States
- Sponsor
- Astex Pharmaceuticals, Inc.
Delay in GI Recovery/Postoperative Ileus (POI)
TU-100 for Accelerating GI Recovery After Major Abdominopelvic Surgery (RC & CAWR)
This Phase 2, multicenter, randomized, double-blind, placebo-controlled master protocol study will evaluate the safety and efficacy of TU-100, adjunctive to an Enhanced Recovery After Surgery (ERAS) pathway, for accelerating…
- Trial name
- NCT07765589
- Testing
- TU-100
- Volunteers
- 240 people
- Sponsor
- Tsumura USA
Colorectal Cancer, Esophageal Cancer
Clinical Trial Protocol for Evaluating the Efficacy and Safety of Thoracoabdominal Endoscopic Surgery System in Remote Laparoscopic Surgery for Urology, General Surgery, Gynecology and Thoracic Surgery
Evaluation of the Efficacy and Safety of the Thoracoabdominal Endoscopic Surgery System Produced by Shenzhen Cornerstone Robotics Technology Co., Ltd.
- Conditions
- Colorectal Cancer, Esophageal Cancer, Hepatectomy, Radical Hysterectomy
- Trial name
- NCT07382635
- Testing
- Robot-assisted surgery
- Volunteers
- 98 people
- Sponsor
- Cornerstone Robotics
Postoperative Gastrointestinal Dysfunction
A Study of Naldemedine in Participants Undergoing Surgeries That Include a Bowel Resection or Bowel Transection
The objective of this study is to compare the efficacy of naldemedine versus placebo and to assess its effect on the time to gastrointestinal (GI) recovery following surgeries that include bowel resection and bowel transection.
- Trial name
- NCT04355169
- Testing
- Naldemedine
- Where
- 8 sites in United States
- Volunteers
- 2 people
- Sponsor
- Shionogi
Gastrointestinal Cancer
Effects of Immunonutrition (Impact Oral®) in Patients Undergoing Surgery for Gastrointestinal Cancer
This study will evaluate the efficacy and safety of Impact Oral in Patients undergoing Surgery for Gastrointestinal Cancer, half of the participants will receive Impact Oral nutrition therapy, the other half will receive Enteral…
- Trial name
- NCT03665714
- Testing
- Impact Oral, Enteral Nutrition Emulsion(TPF-T)
- Where
- China
- Volunteers
- 308 people
- Sponsor
- Société des Produits Nestlé (SPN)
Gastric Cancer, Gastric Adenocarcinoma
Safety and Efficacy Study With Catumaxomab in Patients After Curative Resection of a Gastric Adenocarcinoma
Investigation of the outcome of an adjuvant treatment with catumaxomab as compared to surgery alone in patients after curative resection of a gastric adenocarcinoma in order to gain more detailed information primary on safety…
- Trial name
- NCT00352833
- Testing
- catumaxomab
- Where
- Germany
- Volunteers
- 40 people
- Sponsor
- Neovii Biotech
Colorectal Lesion, Colorectal Adenoma
PARADIGM - En Bloc Trial With the EndoQuest Endoluminal Surgical (ELS) System
The objective of this study is to evaluate the safety and effectiveness of the Endoluminal Surgical (ELS) System in subjects undergoing specified transanal endoluminal procedures in the rectum and sigmoid colon.
- Conditions
- Colorectal Lesion, Colorectal Adenoma, Colorectal Polyp, Rectal Lesion
- Trial name
- PARADIGM (NCT06133387)
- Testing
- Endoscopic submucosal dissection using the ELS System
- Where
- 6 sites in United States
- Volunteers
- 56 people
- Sponsor
- EndoQuest Robotics, Inc.
Advanced Upper Gastrointestinal Tract Adenocarcinoma
A Clinical Trial of a New Combination Treatment, Domvanalimab and Zimberelimab, Plus Chemotherapy, for People With an Upper Gastrointestinal Tract Cancer That Cannot be Removed With Surgery That Has Spread to Other Parts of the Body
This randomized Phase 3 open-label study will compare the efficacy of the T-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif (ITIM) domain (TIGIT) monoclonal antibody domvanalimab, the anti programmed cell…
- Trial name
- STAR-221 (NCT05568095)
- Testing
- Domvanalimab, Zimberelimab, Capecitabine
- Where
- 168 sites in United States, Argentina and 27 more
- Volunteers
- 1,040 people
- Sponsor
- Arcus Biosciences, Inc.
Gastrointestinal Cancer
Effects of 3 Day Preoperative Immunonutrition in Well-nourished Patients With Gastrointestinal (GI) Cancer Undergoing Surgery
Major surgery is still associated with a high rate of postoperative morbidity despite improved techniques in surgical management.
- Trial name
- IPOD-3 (NCT01023412)
- Testing
- Immunonutrition
- Where
- 6 sites in Switzerland
- Volunteers
- 107 people
- Sponsor
- Société des Produits Nestlé (SPN)
Pediatric Procedures, Adult Hepato-pancreato-biliary (HPB) Procedures
A Prospective, Single-Arm Multi-Center Study of the HARMONIC® 1100 Shears in Select Devices
This prospective, single-arm, multi-center study will collect clinical data in a post-market setting for the pediatric population (general surgical procedures) and adult population (general, gynecological, urological, and…
- Conditions
- Pediatric Procedures, Adult Hepato-pancreato-biliary (HPB) Procedures, Adult Lower Gastrointestinal Procedures, Adult Gastric Procedures
- Trial name
- NCT05039021
- Testing
- HARMONIC 1100 Shears
- Where
- 7 sites in United States, Canada and 1 more
- Volunteers
- 265 people
- Sponsor
- Ethicon Endo-Surgery