Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
165 participants
INTERVENTIONAL
2011-04-30
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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abiliti Group
Subjects will receive implanted abiliti System. The device will be activated to deliver therapy at implant. Gastric stimulation performance testing, therapy adjustment and dietary/exercise counseling will be conducted at each visit.
abiliti system implant
Subjects will receive implanted abiliti System.
Gastric Band Group
Subjects will receive an implanted laparoscopic adjustable gastric band. The subjects will have their band adjusted following the standard of care. Dietary/exercise counseling will be conducted at each visit.
Laparoscopic adjustable gastric band (Allergan Lap Band)
Subjects will receive an implanted laparoscopic adjustable gastric band. Specific brand is at the investigator's discretion.
Interventions
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abiliti system implant
Subjects will receive implanted abiliti System.
Laparoscopic adjustable gastric band (Allergan Lap Band)
Subjects will receive an implanted laparoscopic adjustable gastric band. Specific brand is at the investigator's discretion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BMI of 40 to 55 or 35 to 39 with an obesity related comorbid condition 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
* 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.
* Cirrhosis, chronic pancreatitis
* History of intestinal obstruction or adhesive peritonitis
* Any history of peptic ulcer disease within 5 years prior to enrollment
* 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.
* Chronic use of aspirin and/or non steroidal anti-inflammatory medications and unwillingness to discontinue use
* Cardiac history that physician feels should exclude the patient from the study.
* Concurrent use of weight loss medications.
* 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
18 Years
60 Years
ALL
No
Sponsors
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IntraPace, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas Horbach, MD
Role: PRINCIPAL_INVESTIGATOR
Stadtkrankenhaus Schwabach
Alberic Fiennes, MD
Role: PRINCIPAL_INVESTIGATOR
St Anthony's Hospital, Surrey, England
Locations
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Polyclinique de Rillieux, Clinique Lyon-Nord
Rillieux Cedex, , France
MIC Ev. Krankenhaus Hubertus
Berlin, , Germany
SRH Wald-Klinikum Gera
Gera, , Germany
Wolfart Klinik
Gräfelfing, , Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Stadtkrankenhaus Schwabach
Schwabach, , Germany
Azienda Ospedaliera- University
Pisa, , Italy
Clinica San Luca Torino
Turin, , Italy
Vicenza Regional Hospital
Vicenza, , Italy
Complutense University of Madrid Hospital Clinico "San Carlos"
Madrid, , Spain
Hospital Virgen del Roció
Seville, , Spain
Klinik Lindberg
Winterthur, , Switzerland
Spire Southampton Hospital
Hampshire, Southampton, United Kingdom
St. Anthony's Hospital
North Cheam, Surrey, United Kingdom
Mid Yorkshire NHS Trust
Dewsbury, West Yorkshire, United Kingdom
Countries
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Central Contacts
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Robert Nardelli
Role: CONTACT
Phone: 650-316-4065
Facility Contacts
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Jerome Dargent, MD
Role: primary
Martin Susewind, MD
Role: primary
Christine Stroh, MD
Role: primary
Oliver Mann, MD
Role: primary
Thomas Horbach, MD
Role: primary
Marco Anselmino, MD
Role: primary
Giuseppe M Rovera, MD
Role: primary
Franco Favretti, MD
Role: primary
Antonio J Torres, MD
Role: primary
Salvador Morales Conde, MD
Role: primary
Fritz Horber, MD
Role: primary
James Byrne, MD
Role: primary
Alberic Fiennes, MD
Role: primary
Chinnadorai Rajeswaran, MD
Role: primary
References
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Morales-Conde S, Alarcon Del Agua I, Busetto L, Favretti F, Anselmino M, Rovera GM, Socas-Macias M, Barranco-Moreno A, Province-Azalde R, Torres AJ. Implanted Closed-Loop Gastric Electrical Stimulation (CLGES) System with Sensor-Based Feedback Safely Limits Weight Regain at 24 Months. Obes Surg. 2018 Jun;28(6):1766-1774. doi: 10.1007/s11695-017-3093-8.
Busetto L, Torres AJ, Morales-Conde S, Alarcon Del Agua I, Moretto C, Fierabracci P, Rovera G, Segato G, Rubio MA, Favretti F. Impact of the feedback provided by a gastric electrical stimulation system on eating behavior and physical activity levels. Obesity (Silver Spring). 2017 Mar;25(3):514-521. doi: 10.1002/oby.21760. Epub 2017 Feb 6.
Alarcon Del Agua I, Socas-Macias M, Busetto L, Torres-Garcia A, Barranco-Moreno A, Garcia de Luna PP, Morales-Conde S. Post-implant Analysis of Epidemiologic and Eating Behavior Data Related to Weight Loss Effectiveness in Obese Patients Treated with Gastric Electrical Stimulation. Obes Surg. 2017 Jun;27(6):1573-1580. doi: 10.1007/s11695-016-2495-3.
Other Identifiers
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CS-007-P
Identifier Type: -
Identifier Source: org_study_id