Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 1:18 AM
NCT ID:
NCT04593693
Brief Summary:
The purpose of this study is to determine if use of the Medela Invia Motion NPWT system supports acceptable progress towards the goal of therapy when treating patients with a variety of wound types during the evaluation period.
Detailed Description:
The primary objective is to evaluate whether clinical opinion of product performance results in expected wound response and outcomes when using the Medela Invia Motion Endure NPWT system during 4-week study duration.
\* Goal of therapy will be defined by the physician according to initial assessment:
Endpoints (dependent on goal of therapy):
* Decrease in wound volume
* Decrease in size of the tunneling area
* Decrease in size of undermining
* Decrease in amount of slough
* Increase in granulation tissue
* Decrease in edema/periwound swelling
* The wound bed is progressing acceptably towards a transition to another treatment modality such as Moist Wound Healing (MWH), surgical closure, or a flap or graft.
\*\*Study endpoint will be determined by physician at the time of enrollment, when the goal of therapy is documented\*\*
Study:
NCT04593693
Study Brief:
Protocol Section:
NCT04593693