Clinical trials: Anastomosis; Complications
Diverticulum, Colon, Colorectal Neoplasms
Data Collection of Patients Treated With the ColonRing™ for the Creation of Circular Compression Anastomosis
The proposed study is a post marketing, observational, retrospective data collection intended to gather and record data on patients treated with the ColonRing™ device in routine clinical practice at a single center.
- Conditions
- Diverticulum, Colon, Colorectal Neoplasms, Crohn Disease, Colitis, Ulcerative
- Trial name
- RETROPRESS (NCT01301417)
- Testing
- ColonRing™
- Where
- United States
- Volunteers
- 171 people
- Sponsor
- novoGI
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
Diverticulum, Colon, Colorectal Neoplasms
A RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing
The proposed study is a post marketing, observational, retrospective data collection intended to gather and record data on patients treated with the ColonRing device in routine clinical practice at 4-6 centers.
- Conditions
- Diverticulum, Colon, Colorectal Neoplasms, Crohn Disease, Colitis, Ulcerative
- Trial name
- NCT01880918
- Where
- 3 sites in United States
- Volunteers
- 200 people
- Sponsor
- novoGI
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.
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
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
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 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.
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 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
Renal Failure, Hemodialysis
GORE VIABAHN Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise AV Grafts in Hemodialysis
The objective of the study is to establish efficacy and safety of the GORE VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface when used to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the…
- Trial name
- REVISE (NCT00737672)
- Testing
- GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface, Percutaneous Transluminal Angioplasty
- Where
- 31 sites in United States
- Volunteers
- 293 people
- Sponsor
- W.L.Gore & Associates
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
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.
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
- 12 sites in United States, Israel
- Volunteers
- 222 people
- Sponsor
- Exero Medical Ltd.
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, 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
End Stage Renal Disease
Clinical Evaluation of a Vascular Venous Anastomotic Connector [InterGraft VIG-only Study]
The InterGraft™ Venous Anastomotic Connector provides an endovascular, minimally invasive means for attachment of an arteriovenous graft to a vein in the upper extremity.
- Trial name
- NCT02532621
- Testing
- Venous InterGraft Connector, sutured arterial anastomosis of an implanted vascular graft for hemodialysis, hemodialysis
- Where
- 10 sites in United States
- Volunteers
- 158 people
- Sponsor
- Phraxis, Inc.
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
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
Stenosis, Restenosis
Clinical Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft in AV Graft Patients (AVeVA)
The objective of this study is to assess the safety and effectiveness of the COVERA™ Vascular Covered Stent for the treatment of stenotic lesions in the upper extremity venous outflow of the Arteriovenous (AV) access circuit.
- Trial name
- AVeVA (NCT02790606)
- Testing
- Covera(TM) Vascular Covered Stent
- Where
- 16 sites in United States
- Volunteers
- 110 people
- Sponsor
- C. R. Bard