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

NCT ID: NCT04250987

Last Updated: 2020-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-23
• Study Completion Date: 2019-04-04

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.

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.

Conditions

Compliance, Patient

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

IC connected to a sensor

Single use of a IC connected to a sensor

Group Type: EXPERIMENTAL

SpeediCath(R)

Intervention Type: DEVICE

IC SpeediCath ® connected to pressure sensor

Interventions

SpeediCath(R)

IC SpeediCath ® connected to pressure sensor

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Coloplast A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fredrik Ceder, M.Sc

Role: STUDY_DIRECTOR

Head of Clinical Operations

Locations

Department of Urology

Copenhagen, , Denmark

Countries

Denmark

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CP304

Identifier Type: -

Identifier Source: org_study_id