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NCT06402097 Clinical Trial

TRIP-patch vs Duplex

Erectile Dysfunction Clinical Trial

Official title:
'Transdermal Rigidity Assessment Via Ischemia of the Penis (TRIP). A New Sensor-driven Device to Measure Maximal Rigidity.'

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06402097
Other study ID # 70945
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 5, 2020
Est. completion date September 25, 2020

Study information
Verified date May 2024
Source St. Antonius Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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

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

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date September 25, 2020
Est. primary completion date September 25, 2020
Accepts healthy volunteers
Gender Male
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Indication for a penile duplex in our andrology clinic Signed informed consent Male Between 18-60 year Exclusion Criteria: - 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Netherlands St Antonius Hospital Nieuwegein Utrecht

Sponsors (1)
Lead Sponsor Collaborator
St. Antonius Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary change in sensor-readings To validate discriminating sensor-readings between flaccid state and full rigidity of the penis 1 hour
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