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NCT Number: NCT04624126

External Device for Erectile Dysfunction (3D-Erect)

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).

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Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Impotentia Erigendi Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Stanford Health Care, Stanford Hospital

Stanford, California, 94305, United States

Location status: Recruiting

Location contact

Alex M Kasman, MD

SUB_INVESTIGATOR

Francesco Del Giudice, MD

SUB_INVESTIGATOR

Satvir Basran

CONTACT

[email protected]

(650) 723-0948

Tony Chen, MD

SUB_INVESTIGATOR

About this study

A clinical trial to test the safety and feasibility of our newly developed non-invasive 3D-printed external penile device for the treatment and recovery of erectile dysfunction.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3D-Erect

Device

3D-printed erectile device for intercourse

Primary outcomes

  1. Change in modified International Index of Erectile Dysfunction score

    Time frame: baseline and up to 1 month post-baseline

    score 0 to 30 with higher score meaning overall better erectile function

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Non-invasive External Device for Erectile Dysfunction (3D-Erect): a Pilot Study

Acronym: 3D-Erect

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Nov 10, 2020
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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