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

NCT04250987 | Completed Results

• 1 other identifier: CP304
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Compliance, Patient

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

IC connected to a sensor

EXPERIMENTAL

Single use of a IC connected to a sensor

Device: SpeediCath(R)

Interventions

SpeediCath(R) DEVICE

IC SpeediCath ® connected to pressure sensor

IC connected to a sensor

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: at least 4 of each gender
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have given written informed consent
• Be at least 18 years of age and have full legal capacity

You may not qualify if:

• Previous history of genitourinary disease in-cluding congenital abnormalities and surgical procedures performed in the urinary tract
• Symptoms of urinary tract infections (fre-quent urination, stinging and pain at urina-tion)
• Known hypersensitivity toward any of the test products
• Positive pregnancy tes for women

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (1)

Department of Urology

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Vice President, Medical Affairs
• Organization: Coloplast

clinical-studies@coloplast.com

+45 4911 1111

Study Officials

• Fredrik Ceder, M.Sc

  Head of Clinical Operations

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single arm - open-label study

Study Record Dates

• First Submitted: January 21, 2020
• First Posted: January 31, 2020
• Study Start: March 23, 2019
• Primary Completion: April 4, 2019
• Study Completion: April 4, 2019
• Last Updated: September 21, 2020
• Results First Posted: September 21, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)