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:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2025-12-25 @ 1:04 AM
NCT ID:
NCT06407193
Eligibility Criteria:
Inclusion Criteria:
* Women aged between 20 and 55 years who underwent sleeve gastrectomy as primary procedure with either TWL \< 25% or TWL \> 35%.
* Patients who had a follow-up period of 2-3 years after sleeve gastrectomy
Exclusion Criteria:
* Maximum BMI \>50 kg/m2
* Patients with a disease known to affect appetite, gastric emptying or gastrointestinal motility
* Patients who are unable to stop medications that affect gastric emptying and/or motility prior to measurements. It is depending on t1/2 for how long they need to stop medication
* Patients who started menopause
* Patients with gastrointestinal problems or, gastric or intestinal diseases
* Patients with a drug or alcohol addiction
* Patients who are unable to stop smoking for 24h
* Patients who are pregnant or lactating
* Patients who have an intolerance or allergy for one of the components of the test product
* Patients who have a contra-indication to MRI scanning
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT06407193
Study Brief:
Protocol Section:
NCT06407193