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 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT05450393
Eligibility Criteria:
Inclusion Criteria:
1. Adult male and female subjects (≥18 years)
2. The subject underwent a SOC PillCamTM SB3 CE procedure and is referred to a subsequent DAE procedure(s), as part of the routine care or The subject underwent a SOC PillCamTM SB3 CE procedure (not necessarily followed by a DAE) and abnormal findings were indicated in the CE report (optional).
3. The subject received an explanation and understands the nature of the study and provided oral consent.
Exclusion Criteria:
1\. The subject is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05450393
Study Brief:
Protocol Section:
NCT05450393