Clinical trials: Leak, Anastomotic
Anastomotic Leak
Use of NERv's Inline Device as an Early Diagnostic Method for Anastomotic Leak.
NERv's early feasibility clinical trial is a first-in-human, multi-center, pre-market, non-randomized clinical trial intended to evaluate the safety and collect preliminary data necessary for the detection of clinical…
- Trial name
- NCT04253028
- Testing
- NERv's Inline Device
- Where
- 2 sites in Egypt
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- FluidAI Medical
Anastomotic Leak Rectum
Investigation of the Benefit of Using an Autologous Platelet-rich Fibrin Matrix (Obsidian ASG®) for Treatment of Anastomosis During Rectal Surgery
Anastomotic insufficiency remains one of the most significant problems after rectal resection.The complications following anastomotic insufficiency leads to increased morbidity and mortality with subsequent prolongation of…
- Trial name
- ORSY (NCT05174910)
- Testing
- Obsidian ASG
- Where
- 13 sites in Austria, Germany and 3 more
- Volunteers
- 250 people
- Sponsor
- Vivostat
Colorectal Cancer, Rectal Cancer
SafeHeal Colovac Colorectal Anastomosis Protection Device Evaluation (SAFE-2) Pivotal Study
A randomized trial to assess the safety and effectiveness of the Colovac in providing temporary protection of the anastomosis in subjects undergoing lower anterior resection for colorectal cancer.
- Conditions
- Colorectal Cancer, Rectal Cancer, Rectal Tumor, Rectal/Anal
- Trial name
- SAFE-2 (NCT05010850)
- Testing
- Colovac, Stoma Creation
- Where
- 16 sites in United States, Belgium and 1 more
- Volunteers
- 18 people
- Sponsor
- SafeHeal Inc
Open/ Laparoscopic/ Robotic Resection of the Colon
Collection of Electrophysiological Data During Colon Resection
The study is conducted to record continuous electrophysiological signals from intact and ischemic bowel tissue during colonic resection surgery, in order to train the Exero Medical Leak Detection System classification algorithm…
- Trial name
- NCT04854473
- Testing
- Exero Medical Leak Detection System
- Where
- Israel
- Volunteers
- 5 people
- Sponsor
- Exero Medical Ltd.
Colorectal Surgery, Anastomotic Leak
A Safety and Effectiveness Prospective Blinded Clinical Study to Validate xBar System as Monitoring Tool for Anastomotic Leaks Detection
Purpose: To validate the safety and effectiveness of xBar monitoring tool for detection of post-operative anastomotic leaks in subjects undergoing rectal/sigmoid resections with anastomosis.
- Trial name
- NCT06168669
- Testing
- xBar system
- Where
- 13 sites in United States, Israel
- Volunteers
- 222 people
- Sponsor
- Exero Medical Ltd.
Gastrointestinal Anastomotic Complication
a Study to Investigate the Efficacy, and Safety of the Colovac Colorectal Anastomosis Protection Device.
The purpose of this study is to evaluate theColovac 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
- SAFE-1 (NCT03352570)
- Testing
- COLOVAC
- Where
- 3 sites in Belgium, France
- Volunteers
- 15 people
- Sponsor
- Safeheal
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
Anastomotic Leak
Economic Evaluation of Stream™ Platform
This Economic Evaluation study is a multi-center, two-arm, non-randomized, interventional trial. The purpose of this study is to evaluate the economic and patient outcomes of using the Stream™ Platform for early detection of…
- Trial name
- CostAL (NCT05994625)
- Testing
- Stream™ Platform, Stream™ Platform with Risk Score Omitted
- Where
- 2 sites in Canada
- Volunteers
- 215 people
- Sponsor
- FluidAI Medical
Anastomotic Leakage
SEAL Registry - European Registry for the Effectiveness of LifeSeal® Kit
This study will assess the effectiveness of commercially available LifeSeal® Kit as measured by the incidence of post-operative clinical anastomotic leak rates in subjects undergoing low and ultralow anterior resection with an…
- Trial name
- NCT02881359
- Testing
- LifeSeal® Kit
- Where
- 8 sites in Belgium, Netherlands
- Volunteers
- 200 people
- Sponsor
- LifeBond Ltd.
Rectal Cancer, Anastomotic Leak
Efficacy and Safety of LifeSeal™ Kit for Colorectal Staple Line Sealing
LifeSeal™ Kit, surgical sealant designed for staple-line reinforcement that is applied over the anastomotic line to prevent bowel content leakage until full physiological function is restored.
- Trial name
- NCT02907385
- Testing
- LifeSeal™ Kit
- Where
- 39 sites in United States, Belgium and 5 more
- Volunteers
- 736 people
- Sponsor
- LifeBond Ltd.
Esophageal Cancer, Esophagus Cancer
Endoluminal Vacuum Therapy to Prevent Anastomotic Leakage After Esophagectomy Due to Esophageal Cancer
A prospective, multi-centre, exploratory and observational one-arm study to evaluate preventive Endoluminal Vacuum Therapy(pEVT) to prevent anastomotic leakage after esophagectomy due to esophageal cancer.
- Conditions
- Esophageal Cancer, Esophagus Cancer, Anastomotic Leak
- Trial name
- ESPY (NCT06097078)
- Testing
- Eso-SPONGE®
- Where
- Spain
- Volunteers
- 44 people
- Sponsor
- Aesculap AG
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.
Leakage After Esophagectomy, Leakage After Gastrectomy
Eso-Sponge Registry
This international, prospective and multicenter registry was designed to collect clinical evidence for the endoscopic vacuum treatment using Eso-SPONGE® for anastomotic leakage after esophageal resection or iatrogenic or…
- Conditions
- Leakage After Esophagectomy, Leakage After Gastrectomy, Perforation of the Esophagus
- Trial name
- NCT02662777
- Testing
- Eso-SPONGE® vacuum treatment
- Where
- 17 sites in Germany
- Volunteers
- 108 people
- Sponsor
- Aesculap AG
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
Colorectal Anastomosis, Left-sided Colon Resection
Post-Market Study of the Signia Circular Stapler With Tri-Staple Technology in Left-sided Colon, Sigmoid, and Rectal Resections
The purpose of this study is to evaluate the safety and performance of the Signia™ power handle, Signia™ circular adapter, and Signia™ Tri-Staple™ 2.0 circular reloads (hereafter referred to as Signia™ circular stapler) in…
- Conditions
- Colorectal Anastomosis, Left-sided Colon Resection, Anastomotic Leak, Anastomotic Complication
- Trial name
- SECURE (NCT07351071)
- Testing
- Signia™ circular stapler with Tri-Staple™ Technology (Signia™ Circular Stapling system)
- Where
- 10 sites in United States
- Volunteers
- 137 people
- Sponsor
- Medtronic - MITG
Rectal Cancer, Rectal Tumor
Efficacy and Safety of the CG-100 Intraluminal Bypass Device
A randomized trial to assess the safety and efficacy of CG-100 for reducing stoma creation rate in subjects undergoing mesorectal excision.
- Conditions
- Rectal Cancer, Rectal Tumor, Rectal/Anal
- Trial name
- NCT04184973
- Testing
- CG-100 intraluminal bypass device, Stoma
- Where
- 10 sites in United States, Germany and 3 more
- Volunteers
- 250 people
- Sponsor
- Colospan Ltd.
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
Anastomotic Leak, Colon Cancer
Leakage Rate of Ileo-COlic Sutured Anastomosis After Right Hemicolectomy
The primary aim of the study is to show that the ileo-colic anastomosis leakage rate until the first 30 days after surgery using MonoPlus® suture material for anastomosis construction after right hemicolectomy is not inferior to…
- Conditions
- Anastomotic Leak, Colon Cancer, Right Hemicolectomy
- Trial name
- LICOSARH (NCT07132970)
- Testing
- Monoplus Suture Material
- Where
- 4 sites in Germany
- Volunteers
- 249 people
- Sponsor
- Aesculap AG
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