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A Dual-center Study Evaluating Clinical Acceptance of a NPWT Wound Care System

NCT04593693 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2021-09-24

No results posted yet for this study

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.

Conditions

  • Diabetic Foot Ulcer
  • Pressure Injury
  • Pressure Ulcer
  • Surgical Wound
  • Acute Wound
  • Traumatic Wound
  • Dehiscence
  • Edema

Interventions

DEVICE

Invia Motion Endure NPWT system

lightweight portable single patient use pump, that provides continous or intermittent operation and multiple negative pressure selection options

Sponsors & Collaborators

  • Joseph M. Still Research Foundation, Inc.

    collaborator OTHER

  • Medela AG

    lead INDUSTRY

Principal Investigators

  • Claus Brandigi, MD · Joseph M. Still Research Foundation, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-10
Primary Completion
2021-05-18
Completion
2021-05-18
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04593693 on ClinicalTrials.gov