Product Evaluation of a Newly Developed Intermittent Catheter.
1 other identifier
interventional
153
0 countries
N/A
Brief Summary
The aim of the study is to investigate the navigation of a newly developed catheter.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2016
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 15, 2016
CompletedFirst Posted
Study publicly available on registry
November 17, 2016
CompletedResults Posted
Study results publicly available
December 8, 2017
CompletedFebruary 28, 2018
February 1, 2018
Same day
November 15, 2016
August 23, 2017
February 2, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants Successfully Able to Insert Catheter
The subjects had to evaluate if it was possible to insert and navigate the Coloplast Test catheter through urethra by the 5-point Likert question: "How did you find the catheter navigates through the urethra during insertion" ( Very easily, Easily, Neither/nor, Difficultly, Very difficultly, Not possible). The catheterization was considered successful if it was possible to insert the catheter, meaning that ifthey selected any other answer than 'not possible'.
1 week
Study Arms (1)
Testing the new Coloplast Test catheter
EXPERIMENTALThe subjects used the new Coloplast Test catheter for 1 week
Interventions
This is a newly developed catheter
Eligibility Criteria
You may qualify if:
- Male and at least 18 years
- Has used Intermittent self-catheterization at least 3 months
- Has normal to slightly reduced hand mobility
- Use catheter size CH12 or CH14 (must use same size during product evaluation)
You may not qualify if:
- Currently receiving treatment for urinary tract infection
- Currently receiving chemotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Coloplast A/Slead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Head of clinical operations
- Organization
- Clinical operations,Medical Affairs
Study Officials
- STUDY CHAIR
Camilla F Vibjerg, Msc
Head of clinical operation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2016
First Posted
November 17, 2016
Study Start
May 1, 2016
Primary Completion
May 1, 2016
Study Completion
June 1, 2016
Last Updated
February 28, 2018
Results First Posted
December 8, 2017
Record last verified: 2018-02