Exploratory Investigation of Data Obtained From a Sensor Connected to an Intermittent Catheter
|ClinicalTrials.gov Identifier: NCT04250987|
Recruitment Status : Completed
First Posted : January 31, 2020
Results First Posted : September 21, 2020
Last Update Posted : September 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Compliance, Patient||Device: SpeediCath(R)||Not Applicable|
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.
- Single arm. Open-labelled, not randomized
- Healthy volunteers
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single arm - open-label study|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Exploratory Investigation of Data Obtained From a Sensor Connected to an Intermittent Catheter|
|Actual Study Start Date :||March 23, 2019|
|Actual Primary Completion Date :||April 4, 2019|
|Actual Study Completion Date :||April 4, 2019|
Experimental: IC connected to a sensor
Single use of a IC connected to a sensor
IC SpeediCath ® connected to pressure sensor
- Number of Participants With Readability of Pressure Sensor Measurements [ Time Frame: 1 hour ]Determination of whether the sensor could detect changes in pressure in kilopascal (kPa) and provide a readable graph depicting changes in kPa over time of use of IC. Each pressure sensor graph is assessed visually to determine whether the instrument can be used in future studies on a Yes/No basis. The total number of participants with readable pressure sensor measurements were counted.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04250987
|Department of Urology|
|Copenhagen, Denmark, 2100|
|Study Director:||Fredrik Ceder, M.Sc||Head of Clinical Operations|