Performance and Safety Evaluation of the SenSura® Mio Baby Device in Subjects With a Stoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03929978|
Recruitment Status : Not yet recruiting
First Posted : April 29, 2019
Last Update Posted : September 25, 2019
The aim of the non-interventional Post Market Clinical Follow-up (PMCF) study is to follow performance and safety of the newly marketed SenSura® Mio Baby device in a real-life setting.
The objective is to evaluate the SenSura® Mio Baby device performance and safety.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||A Multi-Centre Post Market Clinical Follow-up Study Evaluating Performance and Safety of the SenSura® Mio Baby Device in Subjects With a Stoma|
|Estimated Study Start Date :||October 30, 2019|
|Estimated Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||October 30, 2020|
- Median wear time [ Time Frame: 3 weeks ]