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ACE Stapler Sub Study

NCT02381340 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2018-01-12

No results posted yet for this study

Summary

Obesity and its associated conditions have reached epidemic proportions. Estimates are that about one third of the adults in the United States have obesity. At this moment there are many therapeutic approaches for the treatment of obesity. But, efficacy of most treatment options are limited and so far surgical intervention has been proven to be the only strategy to overcome severe obesity. However, bariatric surgery has limitations and risks, which might be minimized by non-incisional endoscopic procedures.

BaroSense developed a new device, called the Articulating Circular Endoscopic (ACETM) Stapler, which can be used in the treatment of obesity. It is a trans-oral procedure, which intends to reduce the ability of the stomach to expand by creating plications in the region of the fundus and greater curvature. In contrast with other bariatric surgery it is endoscopically performed, reversible and if it fails most future surgical options are still open.

The main study ('Open, prospective study to evaluate the safety and preliminary effectiveness of the BaroSense ACE™ Stapler for the treatment of obesity', multicenter study (MUMC+, AMC and St. Antonius), accepted by MEC AMC) seeks to determine the safety and efficacy of this plicating system for patients with severe obesity.

In this sub-study the investogators want to unravel the exact mechanism and provide more information about the efficacy of the BaroSense ACE™ Stapler. Therefore the authors will measure changes in various parameters that are known to affect weight loss and metabolism, before and after gastric plication (by using the BaroSense ACE™ Stapler) in overweight subjects (these parameters will only be measured in patients at MUMC+). These parameters are post-prandial satiety, food-reward and related brain signalling, gastric emptying, behaviour towards food, food intake, satiety hormone release, microbiota composition and inflammatory markers.

Objectives:

Aim of the present study will be to assess the effect of the BaroSense ACE™ stapler on postprandial satiety, food-reward and related brain signalling, gastric emptying, behaviour towards food, food intake, hormone release, microbiota composition and inflammatory markers.

Conditions

Interventions

DEVICE

ACE stapling procedure

Endoscopic trans-oral gastroplication

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • BaroSense Inc.

    collaborator INDUSTRY

  • Maastricht University Medical Center

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02381340 on ClinicalTrials.gov