Double-S: a Wearable Device for Erectile Dysfunction

NCT ID: NCT05451563

Last Updated: 2025-05-22

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

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-21

Study Completion Date

2026-06-30

Brief Summary

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The purpose of this study is to use a minimally invasive erectile device for patients suffering from erectile dysfunction.

Detailed Description

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The purpose of the study is to use a minimally invasive erectile device support to provide to patients suffering from erectile dysfunction the possibility to achieve satisfactory penetrating intercourse.

The goal of this is to help men who have issues with erectile function (e.g.after radical prostatectomy for prostate cancer, vascular or metabolic erectile dysfunction non-responsive to phosphodiesterase-5 inhibitor medications, etc.) to have medication-free mechanical support for their penis in order to obtain sexual penetration satisfactorily.

Conditions

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Erectile Dysfunction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Double-S arm

Participants will be asked to use the wearable penile device during intercourse.

Group Type EXPERIMENTAL

Double-S

Intervention Type DEVICE

Wearable device for intercourse

Interventions

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Double-S

Wearable 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

Michael Eisenberg M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Eisenberg, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford Healthcare, Stanford Hospital

Stanford, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Satvir Basran

Role: CONTACT

650-723-0948

Other Identifiers

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65457

Identifier Type: -

Identifier Source: org_study_id

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