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

Not Applicable

Completed

• Conditions: Comfort and Performance of Intermittent Catheter
• Interventions: Device: Intermittent Catheter

• Registration Number: NCT03387878
• Lead Sponsor: ConvaTec Inc.

Brief Summary

To evaluate the performance of GentleCath Glide™ Intermittent Catheters

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-01
• Study First Submitted: 2017-08-22
• Study First Submitted QC: 2017-12-22
• Study First Posted: 2018-01-02
• Primary Completion: 2018-01-10
• Study Completion: 2018-01-10
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-05
• Last Update Posted: 2022-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm Study	Intermittent Catheter	This is a single arm study with no comparator

Primary Outcome Measures

Name	Time	Method
Performance/Ease of Use	14 Days	Performance and ease of use will be assessed by both the patient and Investigator. The data will be collected via a questionnaire. The responses will be on a 1 to 5 scale with 1 disagreeing with the statement and 5 agreeing with the statement
Ease of Removal	14 Days	Ease of removal will be assessed by both the patient and Investigator. The data will be collected via a questionnaire. The responses will be on a 1 to 5 scale with 1 disagreeing with the statement and 5 agreeing with the statement
Residue Acceptability	14 Days	Residue acceptability will be assessed by both the patient and Investigator. The data will be collected via a questionnaire. The responses will be on a 1 to 5 scale with 1 disagreeing with the statement and 5 agreeing with the statement

Trial Locations

Locations (1)

Specjalistyczny Gabinet Lekarski; 🇵🇱 Rzeszow, Poland