NCT04250987

Exploratory Investigation of Data Obtained From a Sensor Connected to an Intermittent Catheter

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of the investigational device in the proposed clinical investigation is to capture pressure data prior to and during voiding using a CE-marked commercially available catheter.

Detailed description

This clinical investigation is based on an open explorative design evaluating the sensor ability to record readable data in healthy volunteers and the extent of artifacts influencing data quality and readability in healthy volunteers. Overall: * Single arm. Open-labelled, not randomized * Healthy volunteers Duration: Information visit: Oral and written information about the evaluation is given by the PI or his/her representative. Subjects can continue to visit 0, inclusion visit, the same day - if the subject has decided on participation and if practically possible. Visit 0 - Inclusion visit: Informed consent signed. Subjects can continue to visit 1 - test visit the same day - if practically possible. Visit 1 - test visit: 1h test visit at Rigshospitalet. Fertile females will be asked to perform a pregnancy test. Subject is asked about symptoms for urinary tract infections (frequent urination, stinging or pain at urination). If negative for these symptoms, the subject will be catheterised with (SpeediCath® Standard, male/female, Nelaton tip depending of the gender) with fitted pressure sensor. The urine is led into a standard urine flowmeter.

Conditions

• Compliance, Patient

Interventions

Type	Name	Description
DEVICE	SpeediCath(R)	IC SpeediCath ® connected to pressure sensor

Timeline

• Start date: 2019-03-23
• Primary completion: 2019-04-04
• Completion: 2019-04-04
• First posted: 2020-01-31
• Last updated: 2020-09-21
• Results posted: 2020-09-21

Locations

1 site across 1 country: Denmark