Safety Evaluation of the LGL102 in Obese Subjects Treated With OMS102

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01539850
• Other study ID #: CS-006
• Status: Completed
• Phase: N/A
• First received: February 22, 2012
• Last updated: February 27, 2012
• Start date: March 2010
• Est. completion date: September 2011

Study information

• Verified date: February 2012
• Source: IntraPace, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: September 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity
• Obesity, Morbid

Intervention

Device:
• OMS102
Subjects will receive implanted OMS102 System.

Locations

Country	Name	City	State
Germany	Wolfart Klinik	Graefelfing
Germany	Stadtkrankenhaus Schwabach	Schwabach
Germany	Chirurgische Klinik und Poliklinik I Zentrum für Operative Medizin	Würzburg

Sponsors (1)

Lead Sponsor	Collaborator
IntraPace, Inc

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transgastric sensor site healing	Food sensor transgastric site healing will be evaluated during a gastro endoscopy exam performed three months after implant.	3 months	Yes
Secondary	Excess weight loss	Percentage of excess body weight loss (%EWL) compared to baseline.	3, 6, and 12 months	No
Secondary	Safety Evaluation	Occurrence and severity of all adverse events	3, 6, and 12 months	Yes
Secondary	Quality of Life	Evaluation of the quality of life using the Moorehead-Ardelt II questionnaire	3, 6 and 12 months	No
Secondary	Eating Behavior	Eating behavior (cognitive restraint, uncontrolled eating, and emotional eating) using the Three Factor Eating Questionnaire (TFEQ)	3, 6 and 12 months	No
Secondary	Comorbid Conditions	Any reduction of blood pressure and oral diabetes medications	3, 6 and 12 months	No