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External Device for Erectile Dysfunction (3D-Erect Trial)
N/A
Recruiting
Led By Michael Eisenberg, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and up to 1 month post-baseline
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a non-invasive 3D-printed external penile device to help men with ED have successful and satisfactory sexual intercourse.
Who is the study for?
This trial is for men over 18 with moderate to severe erectile dysfunction from various causes, such as post-prostate cancer treatment or vascular issues. Participants must have a female partner willing to be involved and must be open to trying sexual intercourse using the device.
What is being tested?
The study is evaluating the safety and effectiveness of a non-invasive, 3D-printed external penile device designed to help men with erectile dysfunction achieve satisfactory sexual intercourse.
What are the potential side effects?
Potential side effects are not specified in the provided information but may include discomfort or skin irritation related to wearing an external device.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and up to 1 month post-baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and up to 1 month post-baseline
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in modified International Index of Erectile Dysfunction score
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: 3D-Erect armExperimental Treatment1 Intervention
Participants will be asked to use the 3D-printed penile device during their intercourse with partners.
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Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,472 Previous Clinical Trials
17,501,809 Total Patients Enrolled
2 Trials studying Erectile Dysfunction
25 Patients Enrolled for Erectile Dysfunction
Michael Eisenberg, MDPrincipal InvestigatorStanford University
2 Previous Clinical Trials
26 Total Patients Enrolled
1 Trials studying Erectile Dysfunction
10 Patients Enrolled for Erectile Dysfunction
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My female partner is willing to join the study with me.I am not willing to have sexual vaginal intercourse.You cannot use the external penile device for any reason.I am a man over 18 with moderate to severe erectile dysfunction from various causes.
Research Study Groups:
This trial has the following groups:- Group 1: 3D-Erect arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Erectile Dysfunction Patient Testimony for trial: Trial Name: NCT04624126 — N/A
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