Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2025-12-24 @ 11:00 PM
NCT ID:
NCT01015469
Eligibility Criteria:
Inclusion Criteria:
* BMI ≥ 40 kg /m2 to ≤ 50 kg/m2
* Eating habit: sweet eater and volume eater
* Signed informed consent
* Patients with one or more of the following comorbidities: Hypertension, Diabetes mellitus Type 2, Hyperlipidemia, Hyperuricemia, Sleep apnea, Degenerative diseases of: Spine osteochondrosis, hip, knee, feet
Exclusion Criteria:
* History of obesity surgery
* History of major abdominal surgery with consecutive malabsorption (no resections of the stomach, small and large bowel (exception: appendectomy)
* Patients not eligible to implement silastic ring size 6.5 cm
* History of drug or alcohol abuse
* History of major psychiatric illness conflicting with patient's compliance
* History of recent or chronic steroid medication
* Autoimmune disease
* Inflammatory bowel disease or malabsorptive disease
* Liver cirrhosis (CHILD B + C)
* Active viral or bacterial disease (e.g. HIV, Hepatitis B or C, Tbc etc.)
* Pregnant women or women with childbearing potential without efficient contraception
* History of cancer in the last five years
* Need of long-term anticoagulant medication for any reason
* Any medication with ingredient ASA
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01015469
Study Brief:
Protocol Section:
NCT01015469