Clinical trial Recruiting at 1 site Interventional Ages 18 and up Men only

Wearable device for erectile dysfunction

Official title: Double-S: a Wearable Device for Erectile Dysfunction

Run by Stanford University · NCT05451563 · Data updated 2026-11-12

This study is testing a new wearable device to help men with erectile dysfunction have better sexual experiences without using medication.

Quick facts

Study typeInterventional
Ages18 Years and up
SexMen only
Enrollment10 (estimated)
SponsorStanford University
Academic / other
Drugs / interventionsradiation
Locations1 site (Stanford, California)
StatusRecruiting
StartedMarch 21, 2024
Main results expectedJune 2026
Study endsJune 2026
Registry record updatedMay 22, 2025
Trial IDNCT05451563 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are males over 18 years old experiencing moderate to severe erectile dysfunction from various causes, including post-cancer treatment.

Probably not a fit

Patients who are not willing to attempt sexual intercourse or cannot operate the device will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate a minimally invasive wearable device designed to assist men suffering from erectile dysfunction in achieving satisfactory sexual intercourse. The device provides mechanical support to facilitate penetration without the need for medication. It targets men with various causes of erectile dysfunction, including those who have undergone prostate cancer treatments or have other underlying health issues. Participants will be monitored to assess the effectiveness and usability of the device during sexual activity.

Why it matters

Potential benefit: If successful, this device could offer a medication-free solution for men struggling with erectile dysfunction, improving their sexual health and quality of life.

How similar studies have gone: While there have been various approaches to treating erectile dysfunction, the specific use of this wearable device represents a novel intervention that has not been extensively tested in prior studies.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Stanford Healthcare, Stanford Hospital
    Stanford, California, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.