Clinical Trials Logo
  1. Home
  2. Obese
  3. NCT01388673

Safety and Preliminary Effectiveness of the BaroSense Articulating Circular Endoscopic (ACE) Stapler for Plication of Dilated Post-surgical Gastric Anatomy

Obese Clinical Trial

Official title:
Open Prospective Study to Evaluate the Safety and Preliminary Effectiveness of the BaroSense ACE Stapler for Plication of Dilated Post-surgical Gastric Anatomy

Clinical Trial Summary

The BaroSense Articulating Circular Endoscopic (ACE) Stapler is an investigational instrument indicated for endoluminal trans-oral tissue approximation and ligation in the gastrointestinal tract. This study explores the specific application of tissue apposition in dilated post-surgical gastric anatomy such as observed in a dilated Roux-en-Y Gastric Bypass (RYGB) pouch.

The primary objective of this study is to perform an evaluation of the safety of the ACE Stapler for the treatment of dilated post-surgical gastric anatomy.

The secondary objective of this study is to evaluate the preliminary efficacy of the ACE Stapler for the treatment of dilated post-surgical gastric anatomy over a 12 month follow-up period.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01388673
Study type Interventional
Source BaroSense Inc.
Contact
Status Withdrawn
Phase N/A
Start date October 2011
Completion date February 2013
View Details
See also
  Status Clinical Trial Phase
Completed NCT04105075 - COPD in Obese Patients
Completed NCT04099654 - The Effect of Core Stabilization Exercise Program in Obese Subjects Awaiting Bariatric Surgery N/A
Recruiting NCT05857150 - Exercise Response in Humans With Obesity
Completed NCT03532672 - Early Effect of Fasting on Metabolic, Inflammatory, and Behavioral Responses in Females With and Without Obesity N/A
Completed NCT02086448 - Sleep Disordered Breathing, Obesity and Pregnancy Study (SOAP) N/A
Completed NCT02618486 - The Effects of Obesity on Non Surgical Periodontal Therapy N/A
Completed NCT01724502 - Mitochondrial Dysfunction in Diabetes N/A
Completed NCT01724515 - PGC-1 and Mitochondrial Dysfunction in Diabetes N/A
Active, not recruiting NCT01634204 - Efficacy of a Web-based Weight Loss Program Phase 2
Completed NCT01479933 - Glucose Metabolism Effects of Vitamin D Supplementation in Prediabetes N/A
Completed NCT01421589 - Growth Hormone Treatment on Phosphocreatine Recovery in Obesity N/A
Completed NCT03528304 - Native Women's Wellness: Contingency Management for Tobacco Cessation and Weight Loss N/A
Completed NCT01467817 - Obesity/Overweight in Persons With Early and Chronic Spinal Cord Injury (SCI) N/A
Completed NCT01726647 - Metabolism Associated With Abdominal Fat Mass Distribution N/A
Active, not recruiting NCT02125149 - The Expecting Study N/A
Completed NCT05737927 - Pharmacodynamics and Pharmacokinetics of Different Glucose Bead Formulations in Obese Healthy Subjects Phase 1
Completed NCT05433506 - Safety and Pharmacokinetics of HU6 Phase 1
Completed NCT02871882 - Ox Bile- Conjugated Bile Acids Sodium in Type II Diabetes Mellitus Phase 2
Completed NCT03298464 - Study of NGM313 in Obese Participants Phase 1
Completed NCT05061173 - Comparison of Aerobic, Resistance, and Combined Training in Overweight/Obese Hypertensive Adults N/A