Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-27 @ 3:31 AM
Study NCT ID:
NCT04593693
Status:
COMPLETED
Last Update Posted:
2021-09-24
First Post:
2020-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Dual-center Study Evaluating Clinical Acceptance of a NPWT Wound Care System
Sponsor:
Medela AG
Organization:
Study Overview
Official Title:
A Dual-center Study Evaluating Clinical Acceptance of a NPWT Wound Care System to Expected Standards of Care in Post-acute Patients With a Variety of Wound Types
Status:
COMPLETED
Status Verified Date:
2021-09
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:
None
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\*\*
\* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: