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Clinical Trial 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.


Clinical Trial 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. Forty to fifty ostomates will be enrolled from each Nordic country (i.e. 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 user's leakage and QoL will be evaluated by the end-users. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04763863
Study type Observational
Source Coloplast A/S
Contact Birte Petersen, MD
Phone +4552167100
Email birte@meddevhealt.com
Status Recruiting
Phase
Start date October 20, 2020
Completion date September 30, 2021

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