Safety Evaluation of the LGL102 in Obese Subjects Treated With OMS102

Safety Evaluation of the LGL102 in Obese Subjects Treated With OMS102. A Prospective Multicenter Study

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Morbid Obesity
• Intervention / Treatment: Device: OMS102

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Graefelfing, Germany, 92166
    • Wolfart Klinik
  • Schwabach, Germany, 91126
    • Stadtkrankenhaus Schwabach
  • Würzburg, Germany
    • Chirurgische Klinik und Poliklinik I Zentrum für Operative Medizin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transgastric sensor site healing	Food sensor transgastric site healing will be evaluated during a gastro endoscopy exam performed three months after implant.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Excess weight loss	Percentage of excess body weight loss (%EWL) compared to baseline.	3, 6, and 12 months
Safety Evaluation	Occurrence and severity of all adverse events	3, 6, and 12 months
Quality of Life	Evaluation of the quality of life using the Moorehead-Ardelt II questionnaire	3, 6 and 12 months
Eating Behavior	Eating behavior (cognitive restraint, uncontrolled eating, and emotional eating) using the Three Factor Eating Questionnaire (TFEQ)	3, 6 and 12 months
Comorbid Conditions	Any reduction of blood pressure and oral diabetes medications	3, 6 and 12 months

Collaborators and Investigators

• Sponsor: IntraPace, Inc
• Investigators: Principal Investigator: Thomas Horbach, MD, Stadtkrankenhaus Schwabach

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (ACTUAL): April 1, 2011
• Study Completion (ACTUAL): September 1, 2011

Study Registration Dates

• First Submitted: February 22, 2012
• First Submitted That Met QC Criteria: February 27, 2012
• First Posted (ESTIMATE): February 28, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): February 28, 2012
• Last Update Submitted That Met QC Criteria: February 27, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: obesity; morbid obesity; gastric stimulation
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: CS-006