Safety Evaluation of the LGL102 in Obese Subjects Treated With OMS102
This study has been completed.
Information provided by (Responsible Party):
First received: February 22, 2012
Last updated: February 27, 2012
Last verified: February 2012
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.
||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Safety Evaluation of the LGL102 in Obese Subjects Treated With OMS102. A Prospective Multicenter Study
Primary Outcome Measures:
Secondary Outcome Measures:
- Excess weight loss [ Time Frame: 3, 6, and 12 months ] [ Designated as safety issue: No ]
Percentage of excess body weight loss (%EWL) compared to baseline.
- Safety Evaluation [ Time Frame: 3, 6, and 12 months ] [ Designated as safety issue: Yes ]
Occurrence and severity of all adverse events
- Quality of Life [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
Evaluation of the quality of life using the Moorehead-Ardelt II questionnaire
- Eating Behavior [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
Eating behavior (cognitive restraint, uncontrolled eating, and emotional eating) using the Three Factor Eating Questionnaire (TFEQ)
- Comorbid Conditions [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
Any reduction of blood pressure and oral diabetes medications
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||April 2011 (Final data collection date for primary outcome measure)
Subjects will receive implanted OMS102 System.
Other Name: abiliti System
|Ages Eligible for Study:
||18 Years to 60 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01539850
|Graefelfing, Germany, 92166 |
|Schwabach, Germany, 91126 |
|Chirurgische Klinik und Poliklinik I Zentrum für Operative Medizin
|Würzburg, Germany |
||Thomas Horbach, MD
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 22, 2012
||February 27, 2012
||Germany: Federal Institute for Drugs and Medical Devices
Keywords provided by IntraPace, Inc:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 13, 2014
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