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

• Sponsor: Coloplast A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04250987
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1
• Actual Duration (Days): 12
• Patients Per Site Per Month: 30.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Compliance, Patient	Device: SpeediCath(R)	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Single arm - open-label studySingle 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: Mar 23, 2019
• Actual Primary Completion Date: Apr 4, 2019
• Actual Study Completion Date: Apr 4, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IC connected to a sensor Single use of a IC connected to a sensor	Device: SpeediCath(R); IC SpeediCath ® connected to pressure sensor

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Readability of Pressure Sensor Measurements [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Urology	Copenhagen		Denmark	2100

Sponsors and Collaborators

• Coloplast A/S

Investigators

• Study Director: Fredrik Ceder, M.Sc, Head of Clinical Operations

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 30, 2019

More Information

Publications

None provided.

• Responsible Party: Coloplast A/S
• ClinicalTrials.gov Identifier: NCT04250987
• Other Study ID Numbers: CP304
• First Posted: Jan 31, 2020
• Last Update Posted: Sep 21, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

Participant Flow

Arm/Group Title	Participants Undergoing Catheterization With SpeediCath ®
Arm/Group Description	One time use of intermittent catheterization with SpeediCath ® connected to a pressure sensor for 8 males and 4 females
Period Title: Overall Study
STARTED	12
COMPLETED	12
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Participants Undergoing Catheterization With SpeediCath ®
Arm/Group Description	One time use of intermittent catheterization with SpeediCath ® connected to a pressure sensor for 8 males and 4 females
Overall Participants	12
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	12 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	4 33.3%
Male	8 66.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	12 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
Denmark	12 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Readability of Pressure Sensor Measurements
Description	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.
Time Frame	1 hour

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Participants Undergoing Catheterization With SpeediCath ®
Arm/Group Description	One time use of intermittent catheterization with SpeediCath ® connected to a pressure sensor for 8 males and 4 females
Measure Participants	12
Count of Participants [Participants]	11 91.7%

Adverse Events

Time Frame	1 hour
Arm/Group Title	Participants Undergoing Catheterization With SpeediCath ®
Arm/Group Description	One time use of intermittent catheterization with SpeediCath ® connected to a pressure sensor for 8 males and 4 females
All Cause Mortality
	Participants Undergoing Catheterization With SpeediCath ®
	Affected / at Risk (%)	# Events
Total	0/12 (0%)
Serious Adverse Events
	Participants Undergoing Catheterization With SpeediCath ®
	Affected / at Risk (%)	# Events
Total	0/12 (0%)
Other (Not Including Serious) Adverse Events
	Participants Undergoing Catheterization With SpeediCath ®
	Affected / at Risk (%)	# Events
Total	0/12 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.