External Device for Erectile Dysfunction (3D-Erect)

NCT ID: NCT04624126

Last Updated: 2026-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-10

Study Completion Date

2026-12-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Erectile Dysfunction Impotentia Erigendi

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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3D-Erect arm

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

Group Type EXPERIMENTAL

3D-Erect

Intervention Type DEVICE

3D-printed erectile device for intercourse

Interventions

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3D-Erect

3D-printed erectile device for intercourse

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Michael Eisenberg

Associate Professor of Urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Eisenberg, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford Health Care, Stanford Hospital

Stanford, California, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Satvir Basran

Role: primary

(650) 723-0948

Other Identifiers

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IRB-57222

Identifier Type: -

Identifier Source: org_study_id

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