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:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07384559
Eligibility Criteria:
Inclusion Criteria:
1. Has given written informed consent
2. Is at least 18 years old
3. Has full legal capacity
4. Is able (assessed by investigator) and willing to adhere to study procedures during study duration
5. Is able (assessed by investigator) to remain seated in the MRI scanner for minimum 20 minutes\*
6. Known with SCI for a minimum of 1 year\*
7. Has used IC as primary bladder emptying method for at least 3 months\* \* Only for SCI subjects
Exclusion Criteria:
1. Is participating in any other clinical investigation during this investigation
2. Has previously completed this investigation
3. Has any known allergic or hypersensitive reactions to any device or its ingredients used in the investigation
4. Is pregnant
5. Has had surgical procedures performed in the lower urinary tract.
6. Has active/recurrent bladder cancer
7. Has experienced autonomic dysreflexia within the last 2 years
8. Has any MRI-scanning contraindications, according to MR check list provided by the site (e.g. active implants like pacemaker, cochlear implant, event recorder, implanted insulin pump)
9. Has symptoms of UTI at times of inclusion, as judged by the investigator.
10. Has a body weight that exceeds the maximum of 150kg max
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07384559
Study Brief:
Protocol Section:
NCT07384559