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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04250987
Other study ID # CP304
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 23, 2019
Est. completion date April 4, 2019

Study information

Verified date September 2020
Source Coloplast A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date April 4, 2019
Est. primary completion date April 4, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Have given written informed consent

2. Be at least 18 years of age and have full legal capacity

Exclusion Criteria:

1. Previous history of genitourinary disease in-cluding congenital abnormalities and surgical procedures performed in the urinary tract

2. Symptoms of urinary tract infections (fre-quent urination, stinging and pain at urina-tion)

3. Participation in any other clinical investiga-tions during this investigation (Inclusion ? termination)

4. Known hypersensitivity toward any of the test products

5. Positive pregnancy tes for women

Study Design


Related Conditions & MeSH terms


Intervention

Device:
SpeediCath(R)
IC SpeediCath ® connected to pressure sensor

Locations

Country Name City State
Denmark Department of Urology Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Coloplast A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Readability of Pressure Sensor Measurements 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. 1 hour
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