External Device for Erectile Dysfunction (3D-Erect)

Not Applicable

Recruiting

• Conditions: Erectile Dysfunction; Impotentia Erigendi
• Interventions: Device: 3D-Erect

• Registration Number: NCT04624126
• Lead Sponsor: Stanford University

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).

Detailed 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.

Study Timeline

• Study First Submitted: 2020-11-03
• Study First Submitted QC: 2020-11-09
• Study First Posted: 2020-11-10
• Study Start: 2021-07-10
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-14
• Last Update Posted: 2024-05-16
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 9

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
3D-Erect arm	3D-Erect	Participants will be asked to use the 3D-printed penile device during their intercourse with partners.

Primary Outcome Measures

Name	Time	Method
Change in modified International Index of Erectile Dysfunction score	baseline and up to 1 month post-baseline	score 0 to 30 with higher score meaning overall better erectile function

Trial Locations

Locations (1)

Stanford Health Care, Stanford Hospital; 🇺🇸 Stanford, California, United States