NCT01662024

Brief Summary

Gastric restriction is an important principle of both roux-en-Y gastric bypass and laparoscopic adjustable gastric banding. The FDA cleared OverStitch Endoscopic Suturing System (Apollo Endosurgery, Austin, TX) offers the physician the ability to restrict gastric size by approximating tissue endoluminally via an incisionless/per-oral approach. The use of this system has the potential to reduce the complications associated with current surgical approaches while effecting the desired gastric restriction. The primary objective is to collect data on the use of the OverStitch Endoscopic Suturing System (Apollo Endosurgery, Inc. Austin, Texas) for gastric tissue approximation during primary gastric restrictive procedures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Feb 2013

Typical duration for not_applicable obesity

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 10, 2012

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
12 months until next milestone

Results Posted

Study results publicly available

March 30, 2017

Completed
Last Updated

March 30, 2017

Status Verified

February 1, 2017

Enrollment Period

2.2 years

First QC Date

June 15, 2012

Results QC Date

December 7, 2016

Last Update Submit

February 12, 2017

Conditions

ObesityBody WeightOverweight

Keywords

ObesityBMIWeight lossGastric restrictionBariatrics

Outcome Measures

Primary Outcomes (2)

  • Number of Participants With Adverse Events

    Perioperative adverse events were defined as those occurring during the procedure or the post-procedure observation period. Postoperative adverse events were defined as occurring during the first three days after the procedure. Delayed adverse events were defined as occurring on the fourth post-procedure day or afterwards.

    12 months

  • Evaluation of Technical Feasibility of the Procedure

    Technical success was defined by placement of at least 8 running sutures and 4 interrupted sutures in the gastric body with exclusion of the lateral stomach.

    Day 0 - Procedure Day

Secondary Outcomes (5)

  • Percent Excess Weight Loss

    12 Months

  • Durability

    12 months

  • Percentage of Total Body Weight Loss

    12 Months

  • BMI Loss (kg/m^2)

    12 Months

  • Waist Circumference Loss (cm)

    12 Months

Study Arms (1)

Endoscopic gastric restrictive procedure

EXPERIMENTAL

Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.

Device: Endoscopic gastric restrictive procedure

Interventions

Endoscopic gastric restrictive procedureDEVICE

Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures

Also known as: Apollo Overstitch Endoscopic Suturing System
Endoscopic gastric restrictive procedure

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Subject has met diabetic lab testing and all pre-procedural qualifications
  • Subject is ≥ 18 yrs. of age and ≤ 60 yrs. of age
  • Subject has a BMI of \> 30 and \< 35
  • Subject has history of obesity for \> 2 yrs
  • Subject has had no significant weight change (\<5% of total body weight)in last 6 months
  • 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
  • Subject is a reasonable candidate for general anesthesia
  • Subject agrees not to have any additional weight loss surgery or reconstructive surgery that may affect body weight (i.e. mammoplasty, liposuction, lipoplasty, etc) during the trial
  • 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 must be able to fully understand and be willing to sign the informed consent

You may not qualify if:

  • Subject has had significant weight loss in the last 3 months, or between baseline and the study procedure
  • Mallampati (intubation) score greater than 3
  • Subject is observed during EGD to have heavily scarred, malignant or poor quality/friable tissue in areas of the stomach where sutures are to be placed
  • Subject has history or present use of insulin or insulin derivatives for treatment of diabetes
  • Subject has diabetes secondary to a specific 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 history of inflammatory disease of GI tract
  • Subject has a history of intestinal strictures or adhesions
  • Subject has renal and/or hepatic insufficiency
  • Subject has chronic pancreatic disease
  • Subject has history of/or signs and/or symptoms of gastro-duodenal ulcer disease and/or active peptic ulcer
  • 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 has a history of any significant abdominal surgery
  • Subject has had previous bariatric, gastric or esophageal surgery; intestinal obstruction; portal gastropathy; gastrointestinal tumors; esophageal or gastric varices, or gastroparesis
  • Subject has a hiatal hernia \> 2cm
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Jackson Health System

Miami, Florida, 33176, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

St. Joseph's Regional Medical Center at New Jersey

Paterson, New Jersey, 07503, United States

Location

University of Texas at Houston

Bellaire, Texas, 77401, United States

Location

Related Publications (7)

  • Ogden CL, Carroll MD, Curtin LR, McDowell MA, Tabak CJ, Flegal KM. Prevalence of overweight and obesity in the United States, 1999-2004. JAMA. 2006 Apr 5;295(13):1549-55. doi: 10.1001/jama.295.13.1549.

    PMID: 16595758BACKGROUND

  • Willett WC, Dietz WH, Colditz GA. Guidelines for healthy weight. N Engl J Med. 1999 Aug 5;341(6):427-34. doi: 10.1056/NEJM199908053410607. No abstract available.

    PMID: 10432328BACKGROUND

  • Dindo D, Muller MK, Weber M, Clavien PA. Obesity in general elective surgery. Lancet. 2003 Jun 14;361(9374):2032-5. doi: 10.1016/S0140-6736(03)13640-9.

    PMID: 12814714BACKGROUND

  • Sjostrom L, Lindroos AK, Peltonen M, Torgerson J, Bouchard C, Carlsson B, Dahlgren S, Larsson B, Narbro K, Sjostrom CD, Sullivan M, Wedel H; Swedish Obese Subjects Study Scientific Group. Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery. N Engl J Med. 2004 Dec 23;351(26):2683-93. doi: 10.1056/NEJMoa035622.

    PMID: 15616203BACKGROUND

  • Flum DR, Dellinger EP. Impact of gastric bypass operation on survival: a population-based analysis. J Am Coll Surg. 2004 Oct;199(4):543-51. doi: 10.1016/j.jamcollsurg.2004.06.014.

    PMID: 15454136BACKGROUND

  • Szold A, Abu-Abeid S. Laparoscopic adjustable silicone gastric banding for morbid obesity: results and complications in 715 patients. Surg Endosc. 2002 Feb;16(2):230-3. doi: 10.1007/s004640080187. Epub 2001 Oct 5.

    PMID: 11967669BACKGROUND

  • Jirapinyo P, Watson RR, Thompson CC. Use of a novel endoscopic suturing device to treat recalcitrant marginal ulceration (with video). Gastrointest Endosc. 2012 Aug;76(2):435-9. doi: 10.1016/j.gie.2012.03.681. Epub 2012 May 31. No abstract available.

    PMID: 22658388BACKGROUND

MeSH Terms

Conditions

ObesityBody WeightOverweightWeight Loss

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Limitations and Caveats

Early termination and withdrawal of 5 subjects leads to small numbers of subjects analyzed. No sham comparator. Durability measures at 12 month endoscopy was difficult to quantify.

Results Point of Contact

Title
Christopher C. Thompson, MD, MSc
Organization
Brigham and Women's Hospital
ccthompson@bwh.harvard.edu
617-525-8266

Study Officials

  • Christopher C. Thompson, MD, MS

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Open label
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Therapeutic Endoscopy

Study Record Dates

First Submitted

June 15, 2012

First Posted

August 10, 2012

Study Start

February 1, 2013

Primary Completion

May 1, 2015

Study Completion

April 1, 2016

Last Updated

March 30, 2017

Results First Posted

March 30, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will share

Data is available immediately. We will share the outcomes data if a request is made via email to the PI and the data transfer is completed between institutions. Identifying information will not be provided.

Locations

US(4)