Clinical trials: Anastomosis
Biliary Stricture, Biliary Anastomotic Stenosis
DIGEST I Drug Coated Balloon for Biliary Stricture
DIGEST I Pilot study is a feasibility study for evaluating the safety and efficacy of DCBs.
- Conditions
- Biliary Stricture, Biliary Anastomotic Stenosis, Biliary Obstruction, Biliary Disease
- Trial name
- DIGEST (NCT03997994)
- Testing
- GIE Drug Coated Balloon
- Where
- Paraguay
- Volunteers
- 8 people
- Sponsor
- GIE Medical
Anastomosis, Surgical
Evaluation of MUSA-3 in Microsurgical Anastomoses
This study is conducted to evaluate the safety and performance of robot-assisted microsurgical anastomoses with the MUSA-3 system.
- Trial name
- NCT07427823
- Testing
- Robot-assisted microsurgical anastomoses
- Volunteers
- 30 people
- Sponsor
- Microsure
C.Surgical Procedure; Digestive System, Symptomatic Disorders of the Gastrointestinal Tract
An International, Multicentric, Prospective, Observational Study to Evaluate Monosyn® Suture Material for Anastomoses in the Gastrointestinal Tract
The aim of this non-interventional study is to evaluate the efficacy of a monofilament, mid-term absorbable suture material (Monosyn®) for anastomosis performed in the gastrointestinal tract using the frequency of anastomosis…
- Conditions
- C.Surgical Procedure; Digestive System, Symptomatic Disorders of the Gastrointestinal Tract, Gastric Anastomosis (Site), Gastrointestinal Neoplasms
- Trial name
- PROMEGAT (NCT02080702)
- Testing
- Monosyn
- Where
- 5 sites in Malaysia, Philippines and 2 more
- Volunteers
- 106 people
- Sponsor
- Aesculap AG
Colorectal Cancer
SafeHeal Anastomosis Feasibility Evaluation (SAFE)-2023 Study
A feasibility study to assess the early safety and effectiveness of the Colovac 2 device in providing temporary protection of the anastomosis in patients undergoing low anterior resection for colon cancer.
- Trial name
- NCT06540807
- Testing
- Colovac Colorectal Anastomosis Protection Device, Stoma creation
- Where
- Uzbekistan
- Volunteers
- 24 people
- Sponsor
- SafeHeal Inc
Obesity, Type 2 Diabetes Mellitus (T2DM)
Magnetic Duodeno-Ileal Chile Study
The objective of the MagDI Chile Study is to evaluate the feasibility / performance, safety, and initial efficacy of the MagDI System in eligible participants who are indicated for a duodeno-ileal (small bowel) side-to-side…
- Trial name
- NCT06613724
- Testing
- Magnet System, DI Biofragmentable
- Where
- Chile
- Volunteers
- 10 people
- Sponsor
- GT Metabolic Solutions, Inc.
Colorectal Surgery, Colorectal Cancer
Safety and Effectiveness Evaluation of the COLO-BT as an Alternative Treatment to the Ileostomy
The purpose of this study is to evaluate the Colorectal Balloon Tube (hereinafter referred to as COLO-BT™) device, a single use, temporary intraluminal bypass device, intended to reduce contact of fecal content with an…
- Conditions
- Colorectal Surgery, Colorectal Cancer, Rectal/Anal, Ileostomy - Stoma
- Trial name
- COLO-BT (NCT05826743)
- Testing
- COLO BT™, Stoma Creation
- Where
- 3 sites in United States
- Volunteers
- 256 people, healthy volunteers welcome
- Sponsor
- JSR Medical Co., Ltd.
Anastomotic Leaks, Hartmanns Stump Leakage
Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area
This study is intended to evaluate the safety and effectiveness of Sponge-based Endoscopic Vacuum Therapy (EVT) using Endo-SPONGE for the treatment of Anastomotic Leaks (AL) or Hartmann's stump leakages following colorectal…
- Trial name
- DRAIN Lower (NCT07035431)
- Testing
- Endo-SPONGE
- Where
- 10 sites in United States
- Volunteers
- 66 people
- Sponsor
- Boston Scientific Corporation
User-Centered Design, Anastomotic Leak
Evaluating the Effective and Safe Use of Stream™ Platform
The study aims to demonstrate the potential for at-home monitoring using Stream™ Platform, through simulated-use testing. Lay users, defined as subjects or nonprofessional caregivers, will be asked to operate Stream™ Platform.
- Conditions
- User-Centered Design, Anastomotic Leak, Colorectal Surgery, Artificial Intelligence
- Trial name
- Home-Stream (NCT06522061)
- Testing
- Stream™ Platform
- Where
- Canada
- Volunteers
- 25 people
- Sponsor
- FluidAI Medical
Esophagus Cancer, Esophageal Cancer
Utility and Usability of ActivSight™ Laser Speckle Imaging in Visualization of Tissue Perfusion and Blood Flow During Esophageal Surgery in Humans
ActivSight™ combines an innovative form factor and proprietary software to deliver precise, objective, real-time visualization of blood flow and tissue perfusion intraoperatively for laparoscope-based surgery.
- Conditions
- Esophagus Cancer, Esophageal Cancer, Esophageal Neoplasms, Esophageal Diseases
- Trial name
- NCT05591053
- Testing
- ActivSight
- Where
- 2 sites in United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Activ Surgical
Thoracic
MicroCutter in Surgical Stapling - European Trial I
The purpose of this study is to evaluate safety of the Microcutter stapling /cutting device in patients requiring the transection, resection or anastomosis of gastrointestinal tissue in a post-market approval study.
- Trial name
- MET1 (NCT01476761)
- Testing
- Microcutter XPRESS and Microcutter XCHANGE
- Where
- Germany
- Volunteers
- 160 people
- Sponsor
- Cardica, Inc
Anastomotic Leak, Fistula
Use of NERv's Inline Device as an Early Diagnostic Method for Postoperative Complications
NERv's traditional feasibility clinical trial is a multi-center, pre-market, single-arm, and non-randomized trial. This study will involve the retrospective analysis of prospectively collected data.
- Conditions
- Anastomotic Leak, Fistula, Postoperative Leak, Postoperative Pancreatic Fistula
- Trial name
- NCT04582708
- Testing
- NERv's Inline Device
- Where
- 7 sites in United States, Canada and 1 more
- Volunteers
- 316 people
- Sponsor
- FluidAI Medical
Type 2 Diabetes, Obesity
MagDI Diversion Feasibility Study
The purpose of this clinical research study is to evaluate the feasibility of the GT Metabolic Solutions DI Bio-fragmentable Magnetic Anastomosis System (MAGNET System, DI Bio-fragmentable) for creation of a side-by-side…
- Trial name
- NCT05692518
- Testing
- MAGNET System, DI Bio-fragmentable
- Where
- Georgia
- Volunteers
- 15 people
- Sponsor
- GT Metabolic Solutions, Inc.
Colonic Neoplasms, Crohn Disease
Comparison of Intracorporeal and Extracorporeal Anastomoses for Minimally Invasive Right Colectomy
The primary objective of this study is to retrospectively compare the perioperative and short-term (discharge through 30 days) outcomes of intracorporeal and extracorporeal anastomosis in minimally invasive right colectomies for…
- Trial name
- NCT03019016
- Testing
- Right Colectomy
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Intuitive Surgical
Obesity, Type 2 Diabetes
Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions DI Biofragmentable Magnetic Anastomosis System in Mexico
The purpose of this clinical research study is to evaluate the feasibility / performance, safety and initial efficacy of the GT Metabolic Solutions DI Biofragmentable Magnetic Anastomosis System (MAGNET System, DI…
- Trial name
- NCT07085741
- Testing
- MAGNET System, DI Biofragmentable
- Where
- Mexico
- Volunteers
- 10 people
- Sponsor
- GT Metabolic Solutions, Inc.
Left-sided Colon Resection
A Prospective, Multi-Center Evaluation of the ECHELON CIRCULAR Powered Stapler in Left-Sided Colorectal Anastomoses
This prospective clinical study will evaluate the intra-operative performance of the powered circular stapler used in left colectomy procedures in a post-market setting.
- Trial name
- EPMCS-CA (NCT03326895)
- Testing
- Left-sided colon resection
- Where
- 12 sites in United States, Belgium and 3 more
- Volunteers
- 168 people
- Sponsor
- Ethicon Endo-Surgery
Ileal Pouch
Study of EXE-346 Live Biotherapeutic to Reduce High Bowel Movement Frequency in Subjects With an IPAA (PROF)
The aim of this study is to assess the safety and preliminary efficacy of treatment with EXE-346, a live biotherapeutic, which may reduce bowel movement frequency in patients with an ileal pouch-anal anastomosis (IPAA) and lead…
- Trial name
- PROF (NCT05938465)
- Testing
- EXE-346
- Where
- 8 sites in United States
- Volunteers
- 50 people
- Sponsor
- Exegi Pharma, LLC
Small Bowel Anastomosis
Functional Lumen Opening With Self-Forming Magnetic Anastomosis
The primary objective of this trial is to investigate the safety and effectiveness of the Flexagon SFM system plus OTOLoc when used to create a small bowel anastomosis in subjects undergoing laparoscopic small bowel surgery.
- Trial name
- FLOWS (NCT06454916)
- Testing
- Small Bowel Anastomosis with Flexagon SFM Device with OTOLoc
- Where
- 7 sites in United States
- Volunteers
- 79 people
- Sponsor
- GI Windows, Inc.
Rectal Cancer, Ulcerative Colitis
Bioabsorbable Staple Line Reinforcement in Colorectal,Coloanal and Ileoanal Anastomoses
The primary purpose of this prospective, randomized multicenter center study is to evaluate and compare the outcomes of colorectal, coloanal and ileoanal anastomoses reinforced with a bioabsorbable staple line reinforcement…
- Conditions
- Rectal Cancer, Ulcerative Colitis, Familial Adenomatous Polyposis, Diverticulitis
- Trial name
- NCT00663819
- Testing
- GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement, Staple line without reinforcement
- Where
- 16 sites in United States
- Volunteers
- 258 people
- Sponsor
- W.L.Gore & Associates
Prostate Cancer
Global Performance Evaluation of the AMS CONTINUUM™ Device
1. To evaluate Device performance in providing mucosa to mucosa apposition to facilitate sustainable vesico-urethral anastomosis during a radical prostatectomy procedure. 2.
- Trial name
- NCT01083199
- Testing
- CONTINUUM™
- Where
- 2 sites in Greece, Spain
- Volunteers
- 10 people
- Sponsor
- American Medical Systems
Colon Cancer, Gastrointestinal Cancer
Seal-G / Seal-G MIST Study
A prospective, multi-center, open label, study to evaluate safety and performance of Seal-G and Seal-G MIST in reinforcing colonic anastomosis, in subjects undergoing Colon Resection surgery
- Trial name
- NCT04532515
- Testing
- Seal-G Surgical Sealant, Seal-G MIST System
- Where
- 2 sites in Israel
- Volunteers
- 160 people
- Sponsor
- Advanced Medical Solutions Ltd.