Safety Evaluation of the LGL102 in Obese Subjects Treated With OMS102

IntraPace

Status

Completed

Conditions

Obesity

Morbid Obesity

Treatments

Device: OMS102

Study type

Interventional

Funder types

Industry

Identifiers

NCT01539850

CS-006

Details and patient eligibility

About

The main objective of this study is to evaluate the LGL102 implant safety in obese to morbidly obese subjects treated with OMS102 system. The effect of the therapy on body weight changes will be also evaluated.

Enrollment

34 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age of 18 - 60 years old at time of screening
BMI of 35 to 55 at time of screening
History of obesity ≥ 5 years
The subject has been under routine care of the investigator or another single physician that can supply a medical record for at least 6 months prior to enrollment
Women with childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods
No significant weight loss (< 5%) within four months prior to enrollment as documented in the subject's medical record.
Successful psychological evaluation following the institution psychological evaluation protocol for bariatric surgery or successful historic assessment performed no more than 6 months prior to enrollment.
Glycosylated Hemoglobin; HbA1c ≤ 7.0 % at Visit 2 or historic value performed no more than 3 months prior to enrollment.
If taking anti-depressant medications, they must be stable for at least six months prior to enrollment
Willingness to refrain from using prescription, over the counter or herbal weight loss products for the duration of the trial
Alert, mentally competent, and able to understand and willing to comply with the requirements of the clinical trial, and personally motivated to abide by the requirements and restrictions of the clinical trial
Able to provide voluntary informed consent

Exclusion criteria

Any prior bariatric surgery
Other implanted electrical stimulation devices (e.g. pacemaker, defibrillator, neurostimulator)
Diagnosed with past or current psychiatric condition that may impair his/her ability to comply with the study procedures
Use of anti-psychotic medications
Diagnosed with a eating disorder such as bulimia or binge eating
Obesity due to an endocrinopathy (e.g. Cushing disease)
Insulin therapy
GI disease such as hiatal hernia (> 5cm), gastroparesis, esophageal motility disorders or intractable constipation.
Any history of peptic ulcer disease within 5 years prior to enrollment
History of Barrett's esophagus
Women who are pregnant, lactating or anticipate becoming pregnant within 24 months
Arthritis or other pathologies limiting physical activities that physician feels should exclude the patient from the study.
Cardiac history that physician feels should exclude the patient from the study.
Use of another investigational device or agent in the 30 days prior to enrollment
A history of life-threatening disease within 5 years prior to enrollment
Any other condition that, in the opinion of the investigator, would make the subject unsuitable for the study