Safety Evaluation of the LGL102 in Obese Subjects Treated With OMS102

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
IntraPace, Inc
ClinicalTrials.gov Identifier:
NCT01539850
First received: February 22, 2012
Last updated: February 27, 2012
Last verified: February 2012
  Purpose

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 Intervention
Obesity
Morbid Obesity
Device: OMS102

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety Evaluation of the LGL102 in Obese Subjects Treated With OMS102. A Prospective Multicenter Study

Resource links provided by NLM:


Further study details as provided by IntraPace, Inc:

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


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


Enrollment: 34
Study Start Date: March 2010
Study Completion Date: September 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: OMS102
    Subjects will receive implanted OMS102 System.
    Other Name: abiliti System
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01539850

Locations
Germany
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
Investigators
Principal Investigator: Thomas Horbach, MD Stadtkrankenhaus Schwabach
  More Information

No publications provided

Responsible Party: IntraPace, Inc
ClinicalTrials.gov Identifier: NCT01539850     History of Changes
Other Study ID Numbers: CS-006
Study First Received: February 22, 2012
Last Updated: February 27, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by IntraPace, Inc:
obesity
gastric stimulation
morbid obesity

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

ClinicalTrials.gov processed this record on July 09, 2014