Ignite Creation Date:
2025-12-26 @ 4:04 PM
Ignite Modification Date:
2026-02-28 @ 3:30 AM
Study NCT ID:
NCT02746406
Status:
COMPLETED
Last Update Posted:
2017-01-11
First Post:
2016-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Human Factor Study To Asses The Usability And Feasibility Of The Peritron+ During Intended Use
Sponsor:
Laborie Medical Technologies Inc.
Organization:
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2016-09
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:
In a hospital setting, the self-measurement of intravesical pressure (SMIP) assessment will be conducted at full and empty bladder using the Peritron+ and a ruler-based manometry method. In the home setting a human factor/usability study will be conducted to measure the subject's ability to perform a successful SMIP assessment at full and empty bladder with the Peritron+. This study involves the use of the Peritron+, Air-Trap Tubing, a ruler and a clean intermittent catheter (CIC).
Detailed Description:
None
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?: