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Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01388673
• Other study ID #: Protocol 11-02
• Status: Withdrawn
• Phase: N/A
• First received: July 1, 2011
• Last updated: February 7, 2012
• Start date: October 2011
• Est. completion date: February 2013

Study information

• Verified date: February 2012
• Source: BaroSense Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Obese

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
BaroSense Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with adverse events	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).	Post-procedure through 12 months	Yes
Secondary	Percent excess weight loss in participants relative to preop weight	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	Through 12 months post-procedure	No