Treatment for Obesity, Morbid

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Obesity, Morbid
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test the long-term safety and effectiveness of a weight-loss device called the Maestro Rechargeable System. The study will last for five years, and will include both an observational group and a group of people who will be randomly assigned to use the device.

Treatment Effectiveness

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 5 years

5 years
Mean percentage excess weight loss (%EWL) through 5 years
Mean percentage of subjects achieving at least 5 and 10% TBL through 5 years
Mean percentage total body weight loss (%TBL) through 5 years
Percentage of subjects achieving at least 20 and 25%EWL thresholds through 5 years
Rate of device, therapy and procedure-related serious adverse events (SAEs)
Rate of device-related malfunction at 5 years
Rate of therapy-related adverse events at 5 years

Trial Safety

Trial Design

0 Treatment Group

4 Total Participants · 0 Treatment Group

Primary Treatment: Treatment · No Placebo Group · N/A

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years

Who is running the clinical trial?

ReShape LifesciencesLead Sponsor
10 Previous Clinical Trials
1,411 Total Patients Enrolled
2 Trials studying Obesity, Morbid
125 Patients Enrolled for Obesity, Morbid
Charles J Billington, MDPrincipal InvestigatorUniversity of Minnesota
1 Previous Clinical Trials
294 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are at least 18 years old.
You have failed to respond to a supervised diet/exercise program within the last five years.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 3rd, 2021

Last Reviewed: October 2nd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.