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 @ 5:37 PM
Ignite Modification Date:
2025-12-24 @ 5:37 PM
NCT ID:
NCT03341468
Eligibility Criteria:
Inclusion Criteria:
* Patients scheduled to undergo radical prostatectomy at the Massachusetts General Hospital
* Anticipated intra-operative placement of an 18 or 20 French, latex or silicone urethral catheter at the conclusion of the operation (standard of care)
* At least 18 years of age
Exclusion Criteria:
* Inability to speak, read or understand English
* Apparent sore, rash, or infection on the penis
* Anatomic abnormalities that would prevent proper application and use of the device
* Patients with significant physical or mental disability that, in the opinion of the treating surgeon, might prevent safe placement or removal of the device, or completion of the symptom-based survey.
* Patients with fragile skin
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT03341468
Study Brief:
Protocol Section:
NCT03341468