Safety and Preliminary Effectiveness of the BaroSense Articulating Circular Endoscopic (ACE) Stapler for the Treatment of Obesity

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
BaroSense Inc.
ClinicalTrials.gov Identifier:
NCT01429194
First received: September 2, 2011
Last updated: April 9, 2013
Last verified: April 2013
  Purpose

The BaroSense Articulating Circular Endoscopic (ACE) Stapler is an investigational system using endoscopic guidance to trans-orally place plications in the stomach in obese subjects to reduce volume and expansion of the fundus and greater curve to abate hunger as part of a supervised weight reduction program.

The primary objective of this study is to perform an evaluation of the safety of the plication procedure.

The secondary objective of this study is to evaluate the preliminary efficacy of the ACE Stapler for the treatment of obesity over a 24 month follow-up period.


Condition Intervention
Obese
Procedure: BaroSense ACE Stapler

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open, Prospective Study to Evaluate the Safety and Preliminary Effectiveness of the BaroSense ACETM Stapler for the Treatment of Obesity

Resource links provided by NLM:


Further study details as provided by BaroSense Inc.:

Primary Outcome Measures:
  • Proportion of participants with adverse events [ Time Frame: Post-procedure through 24 months ] [ Designated as safety issue: Yes ]
    The primary safety analysis will assess the occurrence of adverse events through 24 months after the plication procedure. Included in this assessment will be the proportion of subjects with any of the following outcomes between enrollment and completion of the 24 month follow-up evaluation: Adverse Events (AE), Adverse Device Effects (ADE), Serious Adverse Events (SAE) and Unanticipated Adverse Device Effects (UADE).


Secondary Outcome Measures:
  • Percent excess weight loss in participants relative to preop weight [ Time Frame: Through 24 months post-procedure ] [ Designated as safety issue: No ]

    Effectiveness measurements will be analyzed relative to baseline. The collected measures will include:

    • Percent excess weight loss (%EWL), defined as: (preop weight-current weight)/(preop weight - ideal weight) *100, where ideal weight is the weight that would correspond to a BMI of 25 based on the subject's height.
    • Total weight lost (kg) and percent weight lost
    • Change in waist circumference
    • Improvement in co-morbid disease(s) including, but not limited to, improvement in vital signs and/or laboratory values


Enrollment: 21
Study Start Date: April 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACE procedure
ACE procedure for the treatment of obesity
Procedure: BaroSense ACE Stapler
The ACE Stapler is used endoscopically, and incorporates a unique tissue capture mechanism to produce large, permanent serosa to serosa plications in a completely trans-oral approach.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject, male or female, is age 18 to 50 years of age.
  2. Subject must be able to understand and be willing to sign an informed consent document.
  3. 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.
  4. 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.
  5. Subject must be fully ambulatory, without chronic reliance on walking aids such as crutches, walkers or a wheelchair.
  6. Subject must be of sufficient and stable medical health, as evaluated by the Principal Investigator.
  7. Subject must have a primary care physician that will manage the subject for any co-morbid conditions throughout the study.
  8. Subject must have failed standard obesity therapy of diet, exercise, behavior modification, and pharmacologic agents either alone or in combination, as assessed by an interview with a member of the study team at baseline.
  9. 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.

Exclusion Criteria:

  1. Subject has history of/or signs and/or symptoms of gastro-duodenal ulcer disease.
  2. 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.
  3. Subject has had significant weight loss in the last 3 months, or between baseline and the study procedure.
  4. Subject has a history or is diagnosed with eating disorders.
  5. Subject has history of peptic ulcer and tests positive for H. pylori, unless treated before the procedure.
  6. Subject has symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease.
  7. Subject has pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer.
  8. 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.
  9. 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01429194

Locations
Canada
University Institute of Cardiology and Pulmonary Medicine of Quebec
Quebec, Canada, G1V 4G5
Sponsors and Collaborators
BaroSense Inc.
  More Information

No publications provided

Responsible Party: BaroSense Inc.
ClinicalTrials.gov Identifier: NCT01429194     History of Changes
Other Study ID Numbers: 11-03
Study First Received: September 2, 2011
Last Updated: April 9, 2013
Health Authority: Canada: IUCPQ Research Ethics Committee

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014