External Device for Erectile Dysfunction (3D-Erect)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorStanford University
About this trial
The aim of this clinical trial is to test the safety and feasibility of a non-invasive 3D-printed external penile device to achieve successful and satisfactory sexual intercourse in men with erectile dysfunction (ED).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
males >18 years old suffering from any cause moderate to severe erectile dysfunction (e.g. ED after radical prostatectomy and/or radiation therapy for prostate cancer and or other pelvic malignancies affecting the sexual potency; emotional and psychological ED; organic vascular and/or metabolic ED etc.)
having a female partner willing to participate in the study.
Disqualifiers
not willing to attempt sexual vaginal intercourse with their partner
inability to wear/operate the external penile device for any reason
Trial design
Design model
Single group
Treatments tested in this trial
3D-Erect
Device3D-printed erectile device for intercourse
Treatment groups
9 Participants
are divided into 1 treatment groupGroup A: 3D-Erect armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in modified International Index of Erectile Dysfunction score
score 0 to 30 with higher score meaning overall better erectile function
Time frame
baseline and up to 1 month post-baselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov