ACE Stapler Sub Study

NCT02381340 | Completed

• 1 other identifier: NL39402.068.12
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Obesity

Keywords

Obesity; Bariatric surgery; Gastric plication; Minimal invasive surgery; gastrointestinal hormones; food-reward; satiety; microbiota

Outcome Measures

Primary Outcomes (1)

• Satiety, food intake and hunger

  This will be evaluated in a test day before, 1 month after and 12 months after the procedure

  1 year

Secondary Outcomes (4)

• Changes in gastrointestinal hormone release

  1 year

• Gastric emptying

  1 year

• Behavior towards food and brain-related signaling

  1 year

• Inflammatory status

  1 year

Interventions

ACE stapling procedure DEVICE

Endoscopic trans-oral gastroplication

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients that will undergo an ACE stapling procedure for the treatment of obesity.

You may qualify if:

• Subject must be able to understand and be willing to sign an informed consent document.
• Subject must be willing and able to participate in all aspects of the study and agree to comply with all study requirements for the duration of the study. This includes availability of reliable transportation and sufficient time to attend all follow-up visits.
• Subject has a BMI of 40 - 45 or 30 to 39.9 plus one or more co-morbid diseases expected to improve with weight loss, including but not limited to hypertension, dyslipidemia, obstructive sleep apnea, or diabetes mellitus.
• Subject must be fully ambulatory, without chronic reliance on walking aids such as crutches, walkers or a wheelchair.
• Subject must be of sufficient and stable medical health, as evaluated by the Principal Investigator.
• Subject must have a primary care physician that will manage the subject for any co-morbid conditions throughout the study.
• Subject must have failed standard obesity therapy of diet, exercise, behaviour modification, and pharmacologic agents either alone or in combination, as assessed by an interview with a member of the study team at baseline.
• Subject agrees to refrain from any type of reconstructive surgery that may affect body weight such as mammoplasty or abdominal lipoplasty or liposuction, during the trial.
• Patient must be included in the main study

You may not qualify if:

• Main study
• Subject has history of/or signs and/or symptoms of gastro-duodenal ulcer disease.
• Subject has poorly controlled diabetes as indicated by the lack of stable diabetes medications and doses over the last month, or has a history of diabetes for greater than 10 years.
• Subject has had significant weight loss in the last 3 months, or between baseline and the study procedure.
• Subject has a history or is diagnosed with eating disorders.
• Subject has history of peptic ulcer and tests positive for H. pylori, unless treated before the procedure.
• Subject has symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease.
• Subject has pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer.
• Subject has significant esophageal disease including Zenker's diverticulum, grade 3-4 reflux esophagitis, stricture, Barrett's esophagus, esophageal cancer, esophageal diverticulum, dysphagia, achalasia, or symptoms of dysmotility.
• Subject is observed during EGD to have heavily scarred, malignant or poor quality/friable tissue in areas of the stomach where plications are to be placed.
• Subject has renal and/or hepatic insufficiency.
• Subject has thyroid disease which is not controlled with medication.
• Subject has a history of intestinal strictures or adhesions.
• Subject has systemic infection in the body at the time of the plication procedure.
• Female subject who is pregnant (i.e., has a positive urine or blood pregnancy test prior to the procedure), is suspected to be pregnant, is lactating or is of childbearing potential but refuses to use adequate contraception during the study.

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Boston Scientific Corporation: collaborator
• BaroSense Inc.: collaborator

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6202ZA, Netherlands

Location

Related Publications (1)

• Paulus GF, van Avesaat M, Crijnen JAW, Ernest van Heurn LW, Westerterp-Plantenga MS, Bouvy ND. Preliminary evidence that endoscopic gastroplication reduces food reward. Appetite. 2020 Jul 1;150:104632. doi: 10.1016/j.appet.2020.104632. Epub 2020 Feb 15.

  PMID: 32070711 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma samples, faeces

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2015
• First Posted: March 6, 2015
• Study Start: June 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: January 12, 2018

Record last verified: 2015-03

Locations

NL (1)