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ObesityNCT01539850

Safety Evaluation of the LGL102 in Obese Subjects Treated With OMS102

A study testing OMS102 in people with Obesity and Morbid Obesity, run by IntraPace, Inc at 3 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Obesity, Morbid Obesity
What is being tested?
OMS102
Type of treatment
Medical device
How many people
34 participants
Where
3 sitesGermany
Study dates
Mar 2010to Sep 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

3 sites in 1 country.

Germany3 sites

  • Wolfart Klinik

    Gräfelfing, 92166

  • Stadtkrankenhaus Schwabach

    Schwabach, 91126

  • Chirurgische Klinik und Poliklinik I Zentrum für Operative Medizin

    Würzburg

Other trials in Germany

About this study

Official title: 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.

Being tested
OMS102
Keywords
obesity, gastric stimulation, morbid obesity
Medical subject headings
Obesity, Obesity, Morbid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OMS102Device

    Also called abiliti System

    Subjects will receive implanted OMS102 System.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Transgastric sensor site healing

    Food sensor transgastric site healing will be evaluated during a gastro endoscopy exam performed three months after implant.

    Measured: 3 months

Secondary outcomes (5)

  1. Excess weight loss

    Percentage of excess body weight loss (%EWL) compared to baseline.

    Measured: 3, 6, and 12 months

  2. Safety Evaluation

    Occurrence and severity of all adverse events

    Measured: 3, 6, and 12 months

  3. Quality of Life

    Evaluation of the quality of life using the Moorehead-Ardelt II questionnaire

    Measured: 3, 6 and 12 months

  4. Eating Behavior

    Eating behavior (cognitive restraint, uncontrolled eating, and emotional eating) using the Three Factor Eating Questionnaire (TFEQ)

    Measured: 3, 6 and 12 months

  5. Comorbid Conditions

    Any reduction of blood pressure and oral diabetes medications

    Measured: 3, 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2012 (estimated)
  2. Study startMar 2010
  3. Primary completionApr 2011
  4. Study completionSep 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01539850
Sponsor's protocol ID
CS-006
Status last verified
Feb 2012
First submitted
22 Feb 2012
Last updated
28 Feb 2012
Results posted
No
Data monitoring committee
No

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.

    PubMed 25771794

Questions about this trial

What is this clinical trial studying?

A study testing OMS102 in people with Obesity and Morbid Obesity, run by IntraPace, Inc at 3 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Transgastric sensor site healing (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01539850, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2012.

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