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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04250987
Recruitment Status : Completed
First Posted : January 31, 2020
Results First Posted : September 21, 2020
Last Update Posted : September 21, 2020
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S

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) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
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

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




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   at least 4 of each gender
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04250987


Locations
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Denmark
Department of Urology
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Coloplast A/S
Investigators
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Study Director: Fredrik Ceder, M.Sc Head of Clinical Operations
  Study Documents (Full-Text)

Documents provided by Coloplast A/S:
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Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT04250987    
Other Study ID Numbers: CP304
First Posted: January 31, 2020    Key Record Dates
Results First Posted: September 21, 2020
Last Update Posted: September 21, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No