Erectile DysfunctionNCT06402097
TRIP-patch vs Duplex
An observational study of Erectile Dysfunction, run by St. Antonius Hospital at 1 site in Netherlands.
Trial summary
To measure saturation and desaturation of the cavernosal tissue with a cutaneous placed penile sensor, before and during full rigidity. To validate discriminating sensor-readings between flaccid state and full rigidity of the penis Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Erectile Dysfunction
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 5 Jun 2020to 25 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Adult
Study population: Patients with ED
Who may be able to join
- Indication for a penile duplex in our andrology clinic Signed informed consent Male Between 18-60 year
Who cannot join
- Patients who are unwilling to sign written informed consent
- Patients unable to undergo a duplex of the penis
- Patients with sickle cell anemia because this could affect the accuracy of the measurements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 'Transdermal Rigidity Assessment Via Ischemia of the Penis (TRIP). A New Sensor-driven Device to Measure Maximal Rigidity.'
To measure saturation and desaturation of the cavernosal tissue with a cutaneous placed penile sensor, before and during full rigidity. To validate discriminating sensor-readings between flaccid state and full rigidity of the penis
Read the detailed description
To measure saturation and desaturation of the cavernosal tissue with a cutaneous placed penile sensor, before and during full rigidity. To validate discriminating sensor-readings between flaccid state and full rigidity of the penis
- Conditions
- Erectile Dysfunction
- Keywords
- rigiscan, erectile dysfunction
- Medical subject headings
- Erectile Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
change in sensor-readings
To validate discriminating sensor-readings between flaccid state and full rigidity of the penis
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start5 Jun 2020
- Primary completion25 Sep 2020
- Study completion25 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evelien Trip, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402097
- Sponsor's protocol ID
- 70945
- Status last verified
- May 2024
- First submitted
- 2 May 2024
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 'Transdermal Rigidity Assessment Via Ischemia of the Penis (TRIP). A New Sensor-driven Device to Measure Maximal Rigidity.'
- ClinicalTrials.gov ID
- NCT06402097
- Acronym / sponsor ID
- 70945
- Conditions
- Erectile Dysfunction
- Keywords
- rigiscan, erectile dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Study start
- 5 Jun 2020 (actual)
- Primary completion
- 25 Sep 2020 (actual)
- Study completion
- 25 Sep 2020 (actual)
- First posted
- 7 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To measure saturation and desaturation of the cavernosal tissue with a cutaneous placed penile sensor, before and during full rigidity. To validate discriminating sensor-readings between flaccid state and full rigidity of the penis
Detailed description
To measure saturation and desaturation of the cavernosal tissue with a cutaneous placed penile sensor, before and during full rigidity. To validate discriminating sensor-readings between flaccid state and full rigidity of the penis
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Age groups
- Adult
- Study population
- Patients with ED
Key inclusion criteria (1 listed)
- Indication for a penile duplex in our andrology clinic Signed informed consent Male Between 18-60 year
Key exclusion criteria (3 listed)
- Patients who are unwilling to sign written informed consent
- Patients unable to undergo a duplex of the penis
- Patients with sickle cell anemia because this could affect the accuracy of the measurements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
change in sensor-readings
Time frame: 1 hour
To validate discriminating sensor-readings between flaccid state and full rigidity of the penis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Erectile Dysfunction, run by St. Antonius Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in sensor-readings (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024; AzTrials last refreshed its copy on 27 Oct 2026.