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 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT03389269
Eligibility Criteria:
Inclusion Criteria:
* Patient who have had the Aspire Assist inserted (the aspiration therapy group)
* Age between 18-75 years
* Able to understand written patient information and sign informed consent
Exclusion Criteria:
* Diagnosis of type 1 diabetes
* Severe comorbidities that, at the discretion of the investigators, exclude study participation (e.g. chronic obstructive pulmonary disease (COPD) stage III, significant cardiac arrhythmias etc.)
* Previous gastrointestinal surgery (excluding cholecystectomy and appendectomy)
* Gastrointestinal conditions making the participant unsuitable for participation (e.g. ulcerative colitis, Crohn´s disease, clinically significant food allergies, candidiasis etc.)
* Anaemia with a haemoglobin value \<6.2 mmol/l (\<10 g/dl) for women and \<7.4 mmol/l (\< 12 g/dl) for men at time of screening
* Abuse of alcohol and/or drugs, or any other co-existing conditions that will make the participant unsuitable to attend to the study schedule, as deemed by the investigators
* Pregnancy or desire to become pregnant during the study period
* Exceptional conditions which, at the discretion of the investigators, preclude the participation in the study.
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03389269
Study Brief:
Protocol Section:
NCT03389269