Recruiting

3D-Erect

Sponsor:

Stanford University

Code:

NCT04624126

Conditions

Erectile Dysfunction

Impotentia Erigendi

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

3D-Erect

Study Details

Brief summary:

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).

Conditions

Erectile Dysfunction

Impotentia Erigendi

Study ID

NCT04624126

Start date

Jul 10, 2021

Status verified date

Jan, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

9 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: 3D-Erect arm

Participants will be asked to use the 3D-printed penile device during their intercourse with partners.

Interventions

3D-Erect

3D-printed erectile device for intercourse

Primary outcome measure

  • Change in modified International Index of Erectile Dysfunction score [ Time Frame: baseline and up to 1 month post-baseline ]

Central Contacts and Locations

Locations

Stanford Health Care, Stanford Hospital

Recruiting

Stanford, California, United States, 94305

Contacts

Satvir Basran

(650) 723-0948sbasran@stanford.edu

More Information

Sponsor

Stanford University

Last update posted

Jan 13, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-01-13.