NCT05219071

Brief Summary

In men without erectile problems, night time erections occur during the REM-sleep. For this study the current diagnostic test, the Rigiscan is compared, with the data from the TRIP-Patch during the night. To validate discriminating sensor-readings between flaccid state and full rigidity of the penis. Eventually, to have a validated device, a patch in the size of a postage stamp, that easily measures erectile function at home. Furthermore the temperature on the outside of the thigh will be measured.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 1, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

June 20, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2022

Completed
Last Updated

November 21, 2022

Status Verified

November 1, 2022

Enrollment Period

3 months

First QC Date

January 20, 2022

Last Update Submit

November 16, 2022

Conditions

Erectile Dysfunction

Keywords

RigiscanNocturnal erectionTemperatureSaturation

Outcome Measures

Primary Outcomes (2)

  • Change in saturation

    Change in saturation of corpora cavernosa during an erection

    1 night

  • temperature change

    Change in penile skin temperature during an erection

    1 night

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Residents and medical students in the St Antonius Hospital and other volunteers

You may qualify if:

  • Healthy volunteers without (a history of) erectile dysfunction
  • Signed informed consent
  • Male
  • Between 18-40 year

You may not qualify if:

  • Volunteers who are unwilling to sign written informed consent
  • Volunteers with sickle cell anemia because this could affect the accuracy of the measurements
  • Volunteers with erectile dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Antonius Hospital

Nieuwegein, Utrecht, 3435CM, Netherlands

Location

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Study Officials

  • Evelien Trip, drs, MD

    St. Antonius Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 20, 2022

First Posted

February 1, 2022

Study Start

June 20, 2022

Primary Completion

September 13, 2022

Study Completion

September 14, 2022

Last Updated

November 21, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)