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

Compliance, Patient Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04250987
• Other study ID #: CP304
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Compliance, Patient

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