Testing a 3D-printed device for erectile dysfunction
Non-invasive External Device for Erectile Dysfunction (3D-Erect): a Pilot Study
NA · Stanford University · NCT04624126
This study is testing a new 3D-printed device to see if it can help men with erectile dysfunction have better sexual experiences.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 9 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Stanford University (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Stanford, California) |
| Trial ID | NCT04624126 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and feasibility of a non-invasive, 3D-printed external penile device designed to help men with erectile dysfunction achieve satisfactory sexual intercourse. Participants will include men over 18 years old experiencing moderate to severe erectile dysfunction due to various causes. The study will assess how effectively the device can assist in restoring sexual function and satisfaction. The trial will take place at Stanford Health Care, where participants will be monitored for their experiences and outcomes while using the device.
Who should consider this trial
Good fit: Ideal candidates are men over 18 with moderate to severe erectile dysfunction and a willing female partner.
Not a fit: Patients who are not willing to attempt sexual intercourse or cannot use the device will not benefit from this study.
Why it matters
Potential benefit: If successful, this device could provide a new, non-invasive treatment option for men suffering from erectile dysfunction.
How similar studies have performed: While there have been various approaches to treating erectile dysfunction, the use of a 3D-printed external device is a novel approach that has not been extensively tested in clinical settings.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Stanford, California
- Stanford Health Care, Stanford Hospital — Stanford, California, United States (RECRUITING)
Study contacts
- Principal investigator: Michael Eisenberg, MD — Stanford University
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Erectile Dysfunction, Impotentia Erigendi