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 @ 4:47 PM
Ignite Modification Date:
2025-12-24 @ 4:47 PM
NCT ID:
NCT00753350
Eligibility Criteria:
Inclusion Criteria:
* Male or female participants, 25 years of age or older and 55 years of age or younger at the time of the first screening visit.
* BMI (Body Mass Index) prior to the first screening visit between 35 - 40 kg/m2.
* General good health confirmed by medical history, physical examination, medication use in the 30 days prior to the baseline visit, and clinical chemistry and hematology lab test results.
* For women of childbearing potential: negative pregnancy test and willingness to use effective contraception during the entire study period.
* Signed informed consent to participate in the study.
* Ability of the participant to comply with all the requirements of the study and participate in all the intensive activities of the study throughout the study period.
Exclusion Criteria:
* Any contraindication to undergoing endoscopic and/or laparoscopic procedures.
* Known gastric motility disorder and/or history of chronic constipation problems.
* Known peptic ulcer and/or previous gastrointestinal antrum and/or pyloric surgery (open or laparoscopic) and/or structural abnormalities of the gastrointestinal tract (drop out criteria).
* History of chronic intestinal diseases or disorders.
* Prior obesity prevention surgical procedure (intra-gastric balloon, Lap band™ procedure, Bariatric surgery or others).
* Significant weight fluctuations (greater than ±5 kg) within the period of three months prior to first screening visit.
* Participants with significant eating pattern alterations according to participant interview.
* Current systemic intake of laxatives, steroids, non-steroidal anti-inflammatory medications, anticoagulants within 30 days prior to the screening visit and for the entire study duration.
* Participants who have a clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation. Such conditions include significant gastrointestinal, cardiovascular, vascular disease, pulmonary/respiratory, hepatic impairment, renal, metabolic diseases, endocrinological, neurological, immune-deficiency, hematopoietic disease, or malignancies as determined by medical history, physical examination, or laboratory tests.
* Participants with any clinically significant abnormality upon physical examination or in the clinical laboratory test values such as abnormal blood test or abnormal blood coagulation test results prior to the baseline visit.
* Participants with any acute medical situation (e.g. severe febrile illness) or any uncontrollable infection, which is considered of significant by the Principal Investigator.
* Participants who have participated in another clinical trial of any kind within three months prior to the screening visit.
* Organ allograft.
* For female participants: planned pregnancy within 6 months from study start, active pregnancy, or breast-feeding.
* For male participants: intention to have a child within 6 months from the baseline visit.
* Any form of substance abuse (including drug or alcohol abuse), psychiatric disorder, or any chronic condition susceptible, in the opinion of the investigator, of interfering with the conduct of the study.
* Participants who are likely to be non-compliant or uncooperative during the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
55 Years
Study:
NCT00753350
Study Brief:
Protocol Section:
NCT00753350