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 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT04496427
Eligibility Criteria:
Inclusion Criteria:
* Males over 19 and under 65 who have participated in the previous clinical investigation (pivotal) and were treated with the investigational medical device and completed all the anticipated visits.
Exclusion Criteria:
* Subjects who have received any procedures or surgeries (penile enhancement procedure, HA filler, collagen, etc.) in the penile area from the time after the participation of the previous clinical investigation (pivotal) and before the screening for this clinical investigation.
* Subjects deemed as ineligible to participate by the investigator
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
19 Years
Maximum Age:
65 Years
Study:
NCT04496427
Study Brief:
Protocol Section:
NCT04496427