NCT04624126

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Jul 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Jul 2021Dec 2026

First Submitted

Initial submission to the registry

November 3, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

July 10, 2021

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

5.4 years

First QC Date

November 3, 2020

Last Update Submit

January 12, 2026

Conditions

Erectile DysfunctionImpotentia Erigendi

Outcome Measures

Primary Outcomes (1)

  • Change in modified International Index of Erectile Dysfunction score

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

    baseline and up to 1 month post-baseline

Study Arms (1)

3D-Erect arm

EXPERIMENTAL

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

Device: 3D-Erect

Interventions

3D-ErectDEVICE

3D-printed erectile device for intercourse

3D-Erect arm

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • not willing to attempt sexual vaginal intercourse with their partner
  • inability to wear/operate the external penile device for any reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford Health Care, Stanford Hospital

Stanford, California, 94305, United States

RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Study Officials

  • Michael Eisenberg, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Urology

Study Record Dates

First Submitted

November 3, 2020

First Posted

November 10, 2020

Study Start

July 10, 2021

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

January 13, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)