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This is an observational study to determine the efficacy and safety of Potenfill for temporary penile enhancement.
The pivotal study of Potenfill has already been completed and this observational study determines the long-term efficacy and safety for up to 24 months in subjects who have been participated and treated in the pivotal study.
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| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction with the appearance of penis assessed by the Subject Satisfaction at 18 months after treatment with Potenfill compared to baseline | Satisfaction with the physical appearance of the penis as assessed by the subject at 18 months after application of the investigational medical device compared to baseline. The Subject Satisfaction score ranges from 1 (extremely unsatisfied) to 7 (extremely satisfied). | 18 months |
| Satisfaction with the appearance of penis assessed by the Subject Satisfaction at 24 months after treatment with Potenfill compared to baseline | Satisfaction with the physical appearance of the penis as assessed by the subject at 24 months after application of the investigational medical device compared to baseline. The Subject Satisfaction score ranges from 1 (extremely unsatisfied) to 7 (extremely satisfied). | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kangdong Sacred Heart Hospital | Seoul | Gangdong-gu | 05355 | South Korea |
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