TRIP-patch vs Duplex
'Transdermal Rigidity Assessment Via Ischemia of the Penis (TRIP). A New Sensor-driven Device to Measure Maximal Rigidity.'
1 other identifier
observational
20
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2020
Shorter than P25 for all trials
1 active site
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 Start
First participant enrolled
June 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 25, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 25, 2020
CompletedFirst Submitted
Initial submission to the registry
May 2, 2024
CompletedFirst Posted
Study publicly available on registry
May 7, 2024
CompletedMay 7, 2024
May 1, 2024
4 months
May 2, 2024
May 2, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change in sensor-readings
To validate discriminating sensor-readings between flaccid state and full rigidity of the penis
1 hour
Eligibility Criteria
Patients with ED
You may qualify if:
- Indication for a penile duplex in our andrology clinic Signed informed consent Male Between 18-60 year
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St Antonius Hospital
Nieuwegein, Utrecht, 3435CM, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Study Principal Investigator
Study Record Dates
First Submitted
May 2, 2024
First Posted
May 7, 2024
Study Start
June 5, 2020
Primary Completion
September 25, 2020
Study Completion
September 25, 2020
Last Updated
May 7, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share