Ignite Creation Date:
2025-12-24 @ 12:54 PM
Ignite Modification Date:
2025-12-31 @ 6:12 AM
Study NCT ID:
NCT01284361
Status:
COMPLETED
Last Update Posted:
2017-02-01
First Post:
2011-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Two Intermittent Urinary Catheters
Sponsor:
Hollister Incorporated
Organization:
Study Overview
Official Title:
User Preference Study to Compare a 40cm Intermittent Catheter to a 30cm Intermittent Catheter
Status:
COMPLETED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an unblinded, multi-center, randomized, controlled, cross-over study assessing wheel-chair bound, male user preference and catheter characteristics of two intermittent urinary catheters. Subjects enrolled in the study will be randomized to order of catheter use. Individual participation will consist of approximately 1 week of product use. The null hypothesis to be tested is there no difference between catheters.
Detailed Description:
1. is male and at least 18 years of age.
2. is self-catheterizing at least 3 times a day.
3. has been performing catheterizations for at least 2 months.
4. is wheelchair bound.
5. is able to use a size 12 or 14 French straight catheter.
6. is willing and able to follow the study protocol and Investigator's instructions.
7. is in the opinion of the Investigator, qualified to participate.
2. is self-catheterizing at least 3 times a day.
3. has been performing catheterizations for at least 2 months.
4. is wheelchair bound.
5. is able to use a size 12 or 14 French straight catheter.
6. is willing and able to follow the study protocol and Investigator's instructions.
7. is in the opinion of the Investigator, qualified to participate.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: