A Multi-centre Clinical Investigation to Assess the Performance of GentleCath™ Glide Intermittent Catheters

NCT ID: NCT03387878

Last Updated: 2022-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2018-01-10

Brief Summary

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To evaluate the performance of GentleCath Glide™ Intermittent Catheters

Detailed Description

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Conditions

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Comfort and Performance of Intermittent Catheter

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Single Arm Study

This is a single arm study with no comparator

Group Type OTHER

Intermittent Catheter

Intervention Type DEVICE

Intermittent urinary catheter for bladder drainage

Interventions

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Intermittent Catheter

Intermittent urinary catheter for bladder drainage

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subjects of 18 years old and above who require intermittent bladder drainage may be recruited into the study
* Subjects must be willing and able to provide written informed consent
* Subjects may be either inpatients or outpatients but must all be capable of completing a patient diary card to record study data
* Subjects must currently use intermittent catheters and have been using intermittent catheters for the last six months
* Patients who self-catheterise at least three times per day
* Able to attend final assessment visit at day 14

Exclusion Criteria

* Subjects who require intermittent catheterisation to administer irrigation or instillation.
* Subjects who are presently participating in another clinical trial.
* Subjects exhibiting any other medical condition which, according to the investigator, justifies the subject's exclusion from the study
* Subjects with known sensitivity to the device components
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ConvaTec Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Specjalistyczny Gabinet Lekarski

Rzeszów, , Poland

Site Status

Countries

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Poland

Other Identifiers

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CC-925-17-U378

Identifier Type: -

Identifier Source: org_study_id

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