TRIP-patch vs Duplex

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06402097

Enrollment

Registered

2024-05-07

Start date

2020-06-05

Completion date

2020-09-25

Last updated

2024-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction

Keywords

rigiscan, erectile dysfunction

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

Detailed description

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

MALE

Age

18 Years to 60 Years

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

Design outcomes

Primary

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

Countries

Netherlands

Outcome results