NCT00411489

Brief Summary

The Roux-En-Y gastric bypass procedure is the most commonly performed bariatric procedure in the United States. Despite initial weight loss, some patients experience weight regain that may be related to an increase in the size of the gastric pouch and/or stoma. A second surgical procedure to reduce the size of the pouch and/or stoma is typically associated with a higher risk of death or complications than the original gastric bypass procedure. This study will evaluate a less invasive, endolumenal alternative to pouch and stoma revision as a means of producing weight loss in patients who have regained weight following gastric bypass.

Trial Health

80
On Track

Trial Health Score

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

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

December 12, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2006

Completed
Last Updated

March 18, 2008

Status Verified

June 1, 2007

First QC Date

December 12, 2006

Last Update Submit

March 17, 2008

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • weight loss

Interventions

endolumenal surgeryPROCEDURE

Eligibility Criteria

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

You may qualify if:

  • yrs of age or older and \< 65 yrs of age
  • At least 2 yrs post-Roux-En-Y gastric bypass surgery
  • Initially achieved at least 50% weight loss
  • At enrollment, has regain at least 15% of weight loss
  • BMI 40 or greater or 35 or greater with one or more co-morbidities
  • Stoma diameter at least 20 mm
  • Completes successful nutritional screening
  • Is a candidate for a surgical revision procedure
  • Is a reasonable risk to undergo general anesthesia
  • Completes successful cardiopulmonary evaluation
  • ASA Classification of less than or equal to III
  • Able to provide written consent
  • Able to return for protocol-specified evaluations

You may not qualify if:

  • Esophageal stricture or other anatomy/condition that precludes passage of endolumenal instruments
  • Previous bariatric revision procedure
  • Has another causal factor for weight regain other than stoma or pouch dilatation
  • Non-mobile or has significant impairment of mobility that will limit compliance with post-op exercise program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

Mt. Sinai School of Medicine

New York, New York, 10029-6574, United States

Location

Columbia-Presbyterian Medical Center

New York, New York, 10032, United States

Location

Oregon Clinic

Portland, Oregon, 97210, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lee L Swanstrom, MD

    Oregon Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 12, 2006

First Posted

December 14, 2006

Last Updated

March 18, 2008

Record last verified: 2007-06

Locations

US(4)