Clinical trial NCT01539850: Safety Evaluation of the LGL102 in Obese Subjects Treated With OMS102
Official title: Safety Evaluation of the LGL102 in Obese Subjects Treated With OMS102. A Prospective Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Morbid Obesity
Keywords: obesity
gastric stimulation
morbid obesity
Lead sponsor: IntraPace, Inc
Sponsor class: INDUSTRY
First posted: 2012-02-28
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Transgastric sensor site healing
timeFrame: 3 months
Secondary outcomes:
measure: Excess weight loss
timeFrame: 3, 6, and 12 months
measure: Safety Evaluation
timeFrame: 3, 6, and 12 months
measure: Quality of Life
timeFrame: 3, 6 and 12 months
measure: Eating Behavior
timeFrame: 3, 6 and 12 months
measure: Comorbid Conditions
timeFrame: 3, 6 and 12 months
Other outcomes:
Locations:
city: Graefelfing
country: Germany
facility: Wolfart Klinik
city: Schwabach
country: Germany
facility: Stadtkrankenhaus Schwabach
city: Würzburg
country: Germany
facility: Chirurgische Klinik und Poliklinik I Zentrum für Operative Medizin
Study officials:
affiliation: Stadtkrankenhaus Schwabach
name: Thomas Horbach, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Horbach T, Thalheimer A, Seyfried F, Eschenbacher F, Schuhmann P, Meyer G. abiliti Closed-Loop Gastric Electrical Stimulation System for Treatment of Obesity: Clinical Results with a 27-Month Follow-Up. Obes Surg. 2015 Oct;25(10):1779-87. doi: 10.1007/s11695-015-1620-z.