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 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT01905956
Eligibility Criteria:
Inclusion Criteria:
* Age 18 to 65 years
* 25≤BMI≤35
* Expressed desire for weight loss
* Accustomed to 3 main meals/day
* Generally in good health
* Consistent and stable body weight 3 months prior to study enrolment
* Consistent regular physical activity
* Commitment to avoid the use of other weight loss products during study
* Commitment to adhere to diet and lifestyle recommended for the study
Exclusion Criteria:
* Known sensitivity to the ingredients of the device
* Presence of any active gastrointestinal disease
* Malabsorption disorders
* Pancreatitis
* Stenosis in the GI tract
* Bariatric surgery
* Any other reason deemed suitable for exclusion, per investigator's judgement
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01905956
Study Brief:
Protocol Section:
NCT01905956