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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01388673
Recruitment Status : Withdrawn
First Posted : July 7, 2011
Last Update Posted : February 8, 2012
Information provided by (Responsible Party):
BaroSense Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Obese Procedure: BaroSense ACE Stapler for plication of dilated post-surgical gastric anatomy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 2011
Estimated Primary Completion Date : February 2013
Estimated Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anatomy
U.S. FDA Resources

Arm Intervention/treatment
Experimental: ACE Stapler procedure
ACE Stapler procedure for the treatment of dilated post-surgical gastric anatomy
Procedure: BaroSense ACE Stapler for plication of dilated post-surgical gastric anatomy
The ACE Stapler is used endoscopically, an incorporates a unique tissue capture mechanism to produce large, permanent serosa to serosa plications in a completely trans-oral approach.

Primary Outcome Measures :
  1. Proportion of participants with adverse events [ Time Frame: Post-procedure through 12 months ]
    The primary safety analysis will assess the occurrence of adverse events through 12 months following procedures. Included in this assessment will be the proportion of subjects with any of the following outcomes between enrollment and completion of the 12 month follow-up evaluation: Adverse Events (AE), Adverse Device Effects (ADE), Serious Adverse Events (SAE) and Unanticipated Adverse Device Effects (UADE).

Secondary Outcome Measures :
  1. Percent excess weight loss in participants relative to preop weight [ Time Frame: Through 12 months post-procedure ]

    Efficacy measurements will be analyzed relative to the surgery visit. 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 calculated from a BMI of 25 based on the subject's height.
    • Total weight lost (kg)
    • Change in body mass index (BMI)
    • Change in waist circumference
    • Improvement in co-morbid disease(s) including, but not limited to, improvement in vital signs and/or laboratory values

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Subject, male or female, is age 18 to 60 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 must be > 2 years post RYGB surgery.
  5. Subject must have documented records indicating an initial achievement of > 60% EWL (based on an ideal weight of 25 BMI) at some point after RYGB surgery.
  6. Subject has a BMI at baseline of > 30 and < 50.
  7. At time of enrollment, subject must have regained at least 35% of the maximum weight lost following RYGB, and the weight regain must have occurred over a period of not less than 3 months from the point of maximum weight loss.
  8. Subject must have a stoma diameter of at least 18 mm.
  9. Subject must be fully ambulatory, without chronic reliance on walking aids such as crutches, walkers or a wheelchair.

Exclusion Criteria:

  1. Subject has a severe eating disorder.
  2. Investigator determines that there is another causal factor for the subject's weight regain other than dilated gastric anatomy.
  3. Subject has previously undergone an endoscopic or surgical repair of dilated pouch or stoma (including sclerotherapy treatments).
  4. Subject had irreversible or life threatening complications following initial RYGB procedure (cardio or respiratory).
  5. Subject has an ongoing severe complication from their initial RYGB procedure (recurrent ventral hernia, pain syndrome, etc.).
  6. Subject has an intragastric fistula, anastomotic leak, or staple/suture line disruption.
  7. Subject has history of/or signs and/or symptoms of gastro-duodenal ulcer disease.
  8. Subject has symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease.
  9. Subject has pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer.

Responsible Party: BaroSense Inc. Identifier: NCT01388673     History of Changes
Other Study ID Numbers: Protocol 11-02
First Posted: July 7, 2011    Key Record Dates
Last Update Posted: February 8, 2012
Last Verified: February 2012

Keywords provided by BaroSense Inc.:
prior RYGB procedure
regained weight over time
dilated pouch and/or stoma