NCT05451563

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress99%
Mar 2024Jun 2026

First Submitted

Initial submission to the registry

July 6, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 11, 2022

Completed
1.7 years until next milestone

Study Start

First participant enrolled

March 21, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

May 22, 2025

Status Verified

May 1, 2025

Enrollment Period

2.2 years

First QC Date

July 6, 2022

Last Update Submit

May 19, 2025

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Change in modified International Index of Erectile Dysfunction score

    score 0 to 30 with higher score meaning better erectile function

    baseline and up to 1 month post-baseline

Study Arms (1)

Double-S arm

EXPERIMENTAL

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

Device: Double-S

Interventions

Double-SDEVICE

Wearable device for intercourse

Double-S arm

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford Healthcare, Stanford Hospital

Stanford, California, 94304, United States

RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Study Officials

  • Michael Eisenberg, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Satvir Basran

CONTACT

650-723-0948sbasran@stanford.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Michael Eisenberg M.D.

Study Record Dates

First Submitted

July 6, 2022

First Posted

July 11, 2022

Study Start

March 21, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

May 22, 2025

Record last verified: 2025-05

Locations

US(1)