Informations générales (source: ClinicalTrials.gov)
Abiliti™ Treatment in Obese Subjects: A Randomized Post-Market Surveillance Multicenter Study
Interventional
N/A
IntraPace, Inc (Voir sur ClinicalTrials)
avril 2011
janvier 2015
29 juin 2024
The main objective of this post-market surveillance study is to compare the subject's
weight loss and quality of life, and device safety performance of the abiliti System and
the adjustable gastric banding therapies in obese to morbidly obese subjects.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Polyclinique de Rillieux, Clinique Lyon-Nord - 69165 - RILLIEUX Cedex - France | Jerome Dargent, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Age of 18 - 60 years old at time of screening
- 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
- Age of 18 - 60 years old at time of screening
- 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
- 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.
- 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