Brief Summary

The purpose of this study is to test the effect of an implanted device that stimulates the stomach to help obese patients lose weight.

Trial Health

On Track

Trial Health Score

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

Enrollment

190

participants targeted

Target at P75+ for not_applicable obesity

Timeline

Completed

Started May 2004

Typical duration for not_applicable obesity

Geographic Reach

1 country

8 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

3.7 years study duration

Study Start

First participant enrolled

May 1, 2004

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed

11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed

8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed

2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed

Last Updated

March 27, 2015

Status Verified

March 1, 2015

Enrollment Period

1.3 years

First QC Date

September 12, 2005

Last Update Submit

March 26, 2015

Conditions

Obesity Morbid Obesity

Keywords

ObesityMorbid ObesitySHAPEIGSImplantable Gastric Stimulator

Outcome Measures

Primary Outcomes (1)

Percent excess weight loss (%EWL) from baseline after 12 months from randomization.
Baseline, 12 months

Secondary Outcomes (7)

Percent excess weight loss (% EWL) from baseline at each study visit
Baseline and each study visit
Change from baseline in levels of satiety and appetite at each study visit.
Baseline and each study visit
Percentage change in body weight and BMI from baseline at each study visit
Baseline and each study visit
Proportion of subjects who attain ≥ 20% EWL from baseline after 12 months from randomization
Baseline and 12 months.
Proportion of subjects who lose ≥ 5% in body weight from baseline through Month 9, and maintain the weight loss for at least 3 months (i.e., through 12 months from randomization)
Baseline and each study visit.
+2 more secondary outcomes

Study Arms (2)

A

ACTIVE COMPARATOR

All subjects enrolled will be implanted with an IGS system. The active group are those randomized to "on" and will receive active stimulation for 12 months.

Device: Transcend II Model 8848

B

PLACEBO COMPARATOR

All subjects enrolled will be implanted with an IGS system. The placebo group are those randomized to "off" and will receive no stimulation for 12 months.

Device: Transcend II Model 8848

Interventions

Transcend II Model 8848DEVICE

All subjects will be implanted with the IGS device and then randomized to "on" or "off" for 12 months. After 12 months all subjects will be turned "on" through 24 month follow up.

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

to 65 years of age at time of screening
BMI of 35 to 55 kg/m2 at time of screening
Patients with a reported history of five years of obesity (BMI \> 30 kg/m2)

You may not qualify if:

Patients who are excluded by the screening algorithm
Patients scoring 29 or higher on the Binge Eating Scale Questionnaire
Patients taking any weight loss medication or other drugs that can affect body weight

Contact the study team to confirm eligibility.