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Clinical Evaluation of a Novel Incisional NPWT System

NCT04488666 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2025-07-03

No results posted yet for this study

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

Conditions

  • Surgical Wound

Interventions

DEVICE

npSIMS

incisional NPWT

Sponsors & Collaborators

  • NAMSA

    collaborator OTHER

  • Aatru Medical LLC

    lead INDUSTRY

Principal Investigators

  • Jon Mathy, MD · 1Auckland Regional Plastic Surgery Unit and University of Auckland School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-26
Primary Completion
2023-08-31
Completion
2025-06-16
FDA Device
Yes

Countries

  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04488666 on ClinicalTrials.gov