Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04763863
Status:
COMPLETED
Last Update Posted:
2021-02-21
First Post:
2021-02-17
Brief Title:
The Nordic Consensus Study
Sponsor:
Coloplast AS
Organization:
Coloplast AS
Study Overview
Official Title:
The Nordic Consensus Study
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
RECRUITING
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:
NCS
Brief Summary:
A Body Assessment Tool was developed to provide nurses with a more structured approach when choosing ostomy products The Body Assessment Tool will to be evaluated in clinical settings
Detailed Description:
The primary objective is to evaluate the usability of the Body Assessment Tool for the nurse The secondary objectives are to explore if the use of Body Assessment Tool has an impact on the leakage associated Quality of Life and leakage incidences for individuals living with ostomies
Forty to fifty ostomates will be enrolled from each Nordic country ie Denmark Sweden Norway and Finland The users will be recruited from 5-10 clinics in each country The evaluation will include 1 visit at the clinic and at least 1 phone call visit to the user end-of study phone visit
The usability of the Body Assessment Tool will be evaluated by the nurses The users leakage and QoL will be evaluated by the end-users
Forty to fifty ostomates will be enrolled from each Nordic country ie Denmark Sweden Norway and Finland The users will be recruited from 5-10 clinics in each country The evaluation will include 1 visit at the clinic and at least 1 phone call visit to the user end-of study phone visit
The usability of the Body Assessment Tool will be evaluated by the nurses The users leakage and QoL will be evaluated by the end-users
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None