External Device for Erectile Dysfunction (3D-Erect)

Stanford University

Status: Enrolling

Conditions: Erectile Dysfunction; Impotentia Erigendi

Treatments: Device: 3D-Erect

Study type: Interventional

Funder types: Other

Identifiers

NCT04624126

IRB-57222

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 9 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

3D-Erect arm

Experimental group

Description:

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

Treatment:

Device: 3D-Erect