Safety Evaluation of the LGL102 in Obese Subjects Treated With OMS102

NCT01539850 | Completed

• 1 other identifier: CS-006
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 3

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.

Conditions

Obesity; Morbid Obesity

Keywords

obesity; gastric stimulation; morbid obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Excess weight loss

  3, 6, and 12 months

• Safety Evaluation

  3, 6, and 12 months

• Quality of Life

  3, 6 and 12 months

• Eating Behavior

  3, 6 and 12 months

• Comorbid Conditions

  3, 6 and 12 months

Interventions

OMS102 DEVICE

Subjects will receive implanted OMS102 System.

Also known as: abiliti System

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IntraPace, Inc: lead

Study Sites (3)

Wolfart Klinik

Gräfelfing, 92166, Germany

Location

Stadtkrankenhaus Schwabach

Schwabach, 91126, Germany

Location

Chirurgische Klinik und Poliklinik I Zentrum für Operative Medizin

Würzburg, Germany

Location

Related Publications (1)

• 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.

  PMID: 25771794 DERIVED

MeSH Terms

Conditions

Obesity; Obesity, Morbid

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas Horbach, MD

  Stadtkrankenhaus Schwabach

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2012
• First Posted: February 28, 2012
• Study Start: March 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: September 1, 2011
• Last Updated: February 28, 2012

Record last verified: 2012-02

Locations

DE (3)