3D-printed device aims to restore sexual function without drugs or surgery
NCT ID NCT04624126
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This pilot study tests a non-invasive 3D-printed external device to help men with erectile dysfunction achieve satisfactory sexual intercourse. Nine men with moderate to severe ED from any cause, along with their female partners, will try the device. The goal is to see if it is safe and improves erectile function.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 9 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2021
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * not willing to attempt sexual vaginal intercourse with their partner * inability to wear/operate the external penile device for any reason
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Stanford Health Care, Stanford Hospital
RECRUITINGStanford, California, 94305, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Does having multiple wives affect Men's sexual health? a new survey asks
- Can adding shockwaves to platelet therapy boost erectile function?
- Shockwaves may speed up erectile recovery after prostate cancer surgery
- Can a Feather-Light penile monitor replace the uncomfortable gold standard?
- Can a Patient's own blood components outperform daily ED pills?