Safety Evaluation of the LGL102 in Obese Subjects Treated With OMS102

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01539850
Recruitment Status : Completed
First Posted : February 28, 2012
Last Update Posted : February 28, 2012
Information provided by (Responsible Party):
IntraPace, Inc

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.

Condition or disease Intervention/treatment Phase
Obesity Morbid Obesity Device: OMS102 Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety Evaluation of the LGL102 in Obese Subjects Treated With OMS102. A Prospective Multicenter Study
Study Start Date : March 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : September 2011

Intervention Details:
    Device: OMS102
    Subjects will receive implanted OMS102 System.
    Other Name: abiliti System

Primary Outcome Measures :
  1. Transgastric sensor site healing [ Time Frame: 3 months ]
    Food sensor transgastric site healing will be evaluated during a gastro endoscopy exam performed three months after implant.

Secondary Outcome Measures :
  1. Excess weight loss [ Time Frame: 3, 6, and 12 months ]
    Percentage of excess body weight loss (%EWL) compared to baseline.

  2. Safety Evaluation [ Time Frame: 3, 6, and 12 months ]
    Occurrence and severity of all adverse events

  3. Quality of Life [ Time Frame: 3, 6 and 12 months ]
    Evaluation of the quality of life using the Moorehead-Ardelt II questionnaire

  4. Eating Behavior [ Time Frame: 3, 6 and 12 months ]
    Eating behavior (cognitive restraint, uncontrolled eating, and emotional eating) using the Three Factor Eating Questionnaire (TFEQ)

  5. Comorbid Conditions [ Time Frame: 3, 6 and 12 months ]
    Any reduction of blood pressure and oral diabetes medications

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01539850

Wolfart Klinik
Graefelfing, Germany, 92166
Stadtkrankenhaus Schwabach
Schwabach, Germany, 91126
Chirurgische Klinik und Poliklinik I Zentrum für Operative Medizin
Würzburg, Germany
Sponsors and Collaborators
IntraPace, Inc
Principal Investigator: Thomas Horbach, MD Stadtkrankenhaus Schwabach

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: IntraPace, Inc Identifier: NCT01539850     History of Changes
Other Study ID Numbers: CS-006
First Posted: February 28, 2012    Key Record Dates
Last Update Posted: February 28, 2012
Last Verified: February 2012

Keywords provided by IntraPace, Inc:
gastric stimulation
morbid obesity

Additional relevant MeSH terms:
Obesity, Morbid
Nutrition Disorders
Body Weight
Signs and Symptoms