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

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: NCT03387878
Recruitment Status : Unknown
Verified December 2017 by ConvaTec Inc..
Recruitment status was:  Active, not recruiting
First Posted : January 2, 2018
Last Update Posted : January 2, 2018
Sponsor:
Information provided by (Responsible Party):
ConvaTec Inc.

Study Description
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Brief Summary:
To evaluate the performance of GentleCath Glide™ Intermittent Catheters

Condition or disease Intervention/treatment Phase
Comfort and Performance of Intermittent Catheter Device: Intermittent Catheter Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Multi-centre Clinical Investigation to Assess the Performance of GentleCath™ Glide Intermittent Catheters
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : January 30, 2018
Estimated Study Completion Date : February 14, 2018
Arms and Interventions
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Arm Intervention/treatment
Single Arm Study
This is a single arm study with no comparator
 Device: Intermittent Catheter
Intermittent urinary catheter for bladder drainage


Outcome Measures
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Primary Outcome Measures :
  1. Performance/Ease of Use [ Time Frame: 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

  2. Ease of Removal [ Time Frame: 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

  3. Residue Acceptability [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT03387878


Locations
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Poland
Specjalistyczny Gabinet Lekarski
Rzeszow, Poland, 35-326
Sponsors and Collaborators
ConvaTec Inc.
More Information
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Responsible Party: ConvaTec Inc.
ClinicalTrials.gov Identifier: NCT03387878    
Other Study ID Numbers: CC-925-17-U378
First Posted: January 2, 2018    Key Record Dates
Last Update Posted: January 2, 2018
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No