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OpenTrials
Completed

NCT Number: NCT06402097

TRIP-patch vs Duplex

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

Completed

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Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year–60 year

Sex eligibility

Male

Study type

Observational

Primary location

St Antonius Hospital

Nieuwegein, Utrecht, 3435CM, Netherlands

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. change in sensor-readings

    Time frame: 1 hour

    To validate discriminating sensor-readings between flaccid state and full rigidity of the penis

Sponsors and collaborators

Lead sponsor

St. Antonius Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 7, 2024
Registry last updated
May 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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