Ignite Creation Date:
2024-05-06 @ 6:25 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05652010
Status:
COMPLETED
Last Update Posted:
2023-09-01
First Post:
2022-12-07
Brief Title:
Clinical Investigation of an Improved Two-piece Stoma Product for People Living With a Stoma
Sponsor:
Coloplast AS
Organization:
Coloplast AS
Study Overview
Official Title:
A Randomized Controlled Clinical Investigation of an Improved Two-piece Stoma Product for People Living With a Stoma
Status:
COMPLETED
Status Verified Date:
2022-12
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:
CP343
Brief Summary:
Open-label randomized controlled comparative cross-over study with 2 test sequences comparing a new 2p coupling system with SenSura Mio Click
Detailed Description:
Open-label randomized controlled comparative cross-over study with 2 test sequences comparing a new 2p coupling system with SenSura Mio Click Each test period is 3 weeks 2 days total study period is 6 weeks 4 days It will be a 11 randomization into the two possible treatment sequences
The investigation will require 50 randomized subjects exp 20 drop-out leading to at least 40 completed subjects The sample size calculation is based on at least 6 bag changes during each test period 2 chang-es per week
All visits will be performed as remote virtual calls At the visits the investigator or designee will give in-structions for the coming period and check that the trial is running as planned At every bag change the sub-ject will be asked to complete a questionnaire
The investigation will require 50 randomized subjects exp 20 drop-out leading to at least 40 completed subjects The sample size calculation is based on at least 6 bag changes during each test period 2 chang-es per week
All visits will be performed as remote virtual calls At the visits the investigator or designee will give in-structions for the coming period and check that the trial is running as planned At every bag change the sub-ject will be asked to complete a questionnaire
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None