Can a Feather-Light penile monitor replace the uncomfortable gold standard?
NCT ID NCT07762469
First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time
Summary
This trial evaluates a new ultra-thin flexible penile monitoring system designed to diagnose erectile dysfunction (ED) by measuring nighttime erections. The current standard device, RigiScan, uses mechanical rings that can be uncomfortable and disrupt sleep, potentially skewing results. The study will compare the new flexible system against RigiScan in 60 men—30 with ED and 30 healthy volunteers—to see if it provides equally accurate measurements while being more comfortable and preserving natural sleep.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Intelligent Flexible Penile Monitoring System
- What this could lead to
- If successful, this could provide a more comfortable and accurate way to diagnose erectile dysfunction, potentially improving patient experience and diagnostic reliability.
- What could go wrong
- The trial is relatively small (60 participants) and early-stage, so results may not generalize. The new device must prove it matches the accuracy of the existing gold standard, and any device has potential for technical issues or user discomfort.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study population consists of adult males (18-70 years old) visiting the Urology Outpatient Clinic of Zhongda Hospital with complaints of erectile dysfunction, as well as healthy male volunteers recruited from the community.
- Ages
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18 to 70 years
- Sex
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Male participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Males aged 18-70 years with good communication and compliance. 2. Able to follow clinical Standard Operating Procedures (SOPs) and complete two-stage nocturnal monitoring and clinic-induced tests. 3. Fully informed about the study and signed the informed consent form. 4. For ED Group: Clinically diagnosed with erectile dysfunction with an IIEF-5 score \< 21. 5. For Healthy Group: Normal erectile function, no history of related physiological diseases or sexual psychological disorders, with an IIEF-5 score ≥ 21. Exclusion Criteria: 1. Systemic diseases: Severe cardiovascular disease (e.g., recent myocardial infarction, unstable angina), uncontrolled severe diabetes, or severe obstructive sleep apnea syndrome. 2. Local anatomical factors: Severe penile malformation, spinal cord injury, or organic structural damage caused by pelvic fracture; or major surgery within the last six months. 3. Skin and allergy factors: Active infection or eczema in the penile area, or known allergy to flexible materials (medical-grade silicone/adhesives). 4. Mental and psychological factors: Untreated or unstable severe depression, anxiety, or other mental disorders. 5. Medication interference: Current use of PDE5 inhibitors, androgens, anti-androgens, or drugs that significantly interfere with REM sleep structure. 6. Other factors: Currently participating in other interventional clinical trials, or judged by researchers to have poor compliance.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009, China
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