NCT01871896

Brief Summary

Morbid obesity and its associated metabolic diseases are on the rise in the United States. Currently, the best treatment for obesity is bariatric surgery where both roux-en-Y gastric bypass and sleeve gastrectomy offer substantial weight loss. Unfortunately, 20% of patients who undergo bariatric surgery fail to lose enough weight defined as less than 50% of excess body weight loss or regain of weight. For those patients who fail to lose weight after bariatric surgery and have failed maximal medical therapy and diet supervision, the treatment is re-operation and revision. Re-operation of the abdomen carries significant postoperative morbidity and mortality. The investigators propose to use the Apollo OverStitch endoscopic suturing device that has already been approved by the FDA as an option for bariatric surgery revision without having to re-operate on the patient. The investigators believe that the endoscopic technique may be able to provide weight loss without having to re-operate on the patient.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

May 11, 2013

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 7, 2013

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

August 16, 2023

Completed
Last Updated

August 16, 2023

Status Verified

July 1, 2023

Enrollment Period

8.4 years

First QC Date

May 11, 2013

Results QC Date

June 22, 2023

Last Update Submit

July 25, 2023

Conditions

Morbid ObesityWeight Loss

Keywords

Surgical EndoscopyMorbid ObesityWeight LossBariatricsSurgical Revision

Outcome Measures

Primary Outcomes (1)

  • Mean Weight Loss

    We will track patient's weight after their endoscopic bariatric surgery.

    3 months after procedure

Secondary Outcomes (2)

  • Number of Participants With Resolved Co-morbidities

    2 years

  • Tolerance

    2 years

Study Arms (1)

Weight Gain

EXPERIMENTAL

Patients who previously underwent bariatric surgery who failed to lose the expected weight or regained weight.

Device: Endoscopic Suturing to Create Early Satiety

Interventions

Endoscopic Suturing to Create Early SatietyDEVICE

Evaluating the efficacy of endoscopic suturing for weight loss.

Also known as: Endoscopic Cerclage, Bariatric Surgery Revision, Apollo EndoStitch, Apollo OverTube
Weight Gain

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Previous Roux-En-Y Gastric Bypass (RYGB) or Sleeve Gastrectomy (SG)
  • Failure to lose \>50% of their excess body weight after 1 year
  • Failure of weight loss despite maximal medical therapy and medically-supervised diets

You may not qualify if:

  • Esophageal Stricture
  • Marginal Ulcer at the gastrojejunostomy anastomosis
  • Non-compliance with bariatric follow-up
  • Gastric ulcers
  • Paraesophageal hernias

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (8)

  • Thompson CC, Chand B, Chen YK, DeMarco DC, Miller L, Schweitzer M, Rothstein RI, Lautz DB, Slattery J, Ryan MB, Brethauer S, Schauer P, Mitchell MC, Starpoli A, Haber GB, Catalano MF, Edmundowicz S, Fagnant AM, Kaplan LM, Roslin MS. Endoscopic suturing for transoral outlet reduction increases weight loss after Roux-en-Y gastric bypass surgery. Gastroenterology. 2013 Jul;145(1):129-137.e3. doi: 10.1053/j.gastro.2013.04.002. Epub 2013 Apr 5.

    PMID: 23567348BACKGROUND

  • Deylgat B, D'Hondt M, Pottel H, Vansteenkiste F, Van Rooy F, Devriendt D. Indications, safety, and feasibility of conversion of failed bariatric surgery to Roux-en-Y gastric bypass: a retrospective comparative study with primary laparoscopic Roux-en-Y gastric bypass. Surg Endosc. 2012 Jul;26(7):1997-2002. doi: 10.1007/s00464-011-2140-0. Epub 2012 Jan 19.

    PMID: 22258299BACKGROUND

  • Kellogg TA. Revisional bariatric surgery. Surg Clin North Am. 2011 Dec;91(6):1353-71, x. doi: 10.1016/j.suc.2011.08.004.

    PMID: 22054158BACKGROUND

  • deWolfe MA, Bower CE. Using the StomaphyX(TM) endoplicator to treat a gastric bypass complication. JSLS. 2011 Jan-Mar;15(1):109-13. doi: 10.4293/108680811X13022985131570.

    PMID: 21902955BACKGROUND

  • Thompson CC, Jacobsen GR, Schroder GL, Horgan S. Stoma size critical to 12-month outcomes in endoscopic suturing for gastric bypass repair. Surg Obes Relat Dis. 2012 May-Jun;8(3):282-7. doi: 10.1016/j.soard.2011.03.014. Epub 2011 Apr 19.

    PMID: 21640665BACKGROUND

  • Raman SR, Holover S, Garber S. Endolumenal revision obesity surgery results in weight loss and closure of gastric-gastric fistula. Surg Obes Relat Dis. 2011 May-Jun;7(3):304-8. doi: 10.1016/j.soard.2011.01.045. Epub 2011 Feb 22.

    PMID: 21474389BACKGROUND

  • Heneghan HM, Yimcharoen P, Brethauer SA, Kroh M, Chand B. Influence of pouch and stoma size on weight loss after gastric bypass. Surg Obes Relat Dis. 2012 Jul-Aug;8(4):408-15. doi: 10.1016/j.soard.2011.09.010. Epub 2011 Sep 23.

    PMID: 22055390BACKGROUND

  • Yimcharoen P, Heneghan HM, Singh M, Brethauer S, Schauer P, Rogula T, Kroh M, Chand B. Endoscopic findings and outcomes of revisional procedures for patients with weight recidivism after gastric bypass. Surg Endosc. 2011 Oct;25(10):3345-52. doi: 10.1007/s00464-011-1723-0. Epub 2011 Apr 30.

    PMID: 21533520BACKGROUND

MeSH Terms

Conditions

Obesity, MorbidWeight Loss

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Results Point of Contact

Title
Matthew Lin
Organization
University of California San Francisco
Matthew.Lin@ucsf.edu
415 353 2161

Study Officials

  • Stanley J Rogers, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • Jonathan T Carter, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • John P Cello, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • Matthew Lin, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2013

First Posted

June 7, 2013

Study Start

January 1, 2014

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

August 16, 2023

Results First Posted

August 16, 2023

Record last verified: 2023-07

Locations

US(1)