Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2026-01-05 @ 1:04 AM
Study NCT ID:
NCT04488666
Status:
COMPLETED
Last Update Posted:
2025-07-03
First Post:
2020-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of a Novel Incisional NPWT System
Sponsor:
Aatru Medical LLC
Organization:
Study Overview
Official Title:
A Clinical Evaluation of a Novel, Single-Use, Negative Pressure Wound Therapy (NPWT) System for the Management of Closed Surgical Wounds
Status:
COMPLETED
Status Verified Date:
2025-07
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:
A study of the first clinical use in humans of a novel NPWT system (npSIMS) to assess the suitability, safety and efficacy of the system for the management of closed surgical wounds
Detailed Description:
The purpose of this investigation is to test the functionality of a novel, non-electric NPWT device: npSIMS (negative pressure Surgical Incision Management System) from Aatru Medical LLC (Ohio, USA) which uses an exothermic chemical process to extract the oxygen from the air contained within the dressing (air contains 21% O2) and hence bring and maintain the system to between -160 and -80 mmHg below atmospheric pressure (760 mmHg). The dressing and the chemical reaction pump module can be manufactured for significantly less than the cost of electromechanical NPWT systems and can be profitably marketed at a discount to the cost of existing commercial devices. The Aatru Medical NPWT system could transform the economics and increase the availability of this therapy across the world.
Study Oversight
Has Oversight DMC:
True
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?:
True
Is an FDA AA801 Violation?: