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 @ 10:30 PM
Ignite Modification Date:
2025-12-24 @ 10:30 PM
NCT ID:
NCT07146035
Eligibility Criteria:
Inclusion Criteria:
Has given written informed consent Is at least 18 years old Has full legal capacity Is able (assessed by the investigator) and willing to adhere to study procedures during study duration.
Has had an ileostomy for at least 30 days. Has been self-managing their own ostomy product for at least 14 days. Has experienced leakage under the baseplate at least 3 times within the past 2 weeks.
Is able to fit one of the two test product sizes (Ø50mm or Ø60mm). Uses a flat baseplate Is willing to change their baseplate daily Has intact peristomal skin (assessed by the investigator) Is able to use a smartphone with camera
Exclusion Criteria:
Is participating in any other clinical investigation during this investigation Has previously participated or completed this investigation Has a known hypersensitivity towards the prototype used in the investigation Is pregnant Is breast feeding Has more than one ostomy synchronously Has ongoing non-healed abdominal wounds Has planned MR scans during the 24-hour test recording
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07146035
Study Brief:
Protocol Section:
NCT07146035