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Confirm Safety and Performance of Avance Solo and Avance Solo Adapt NPWT Systems

NCT04753294 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2023-09-08

No results posted yet for this study

Summary

The primary objective of this post market clinical follow-up (PMCF) investigation is to confirm the safety and performance of Avance®Solo and Avance®Solo Adapt NPWT Systems in low to moderate exuding chronic wounds when used in accordance with the Instructions for Use, for up to 28 days.

Conditions

  • Venous Leg Ulcer
  • Pressure Ulcer
  • Diabetic Foot Ulcer
  • Chronic Ulcer

Interventions

DEVICE

Avance Solo NPWT System

Wound treatment with Avance Solo NPWT System for up to 28 days.

DEVICE

Avance Solo Adapt NPWT System

Wound treatment with Avance Solo Adapt NPWT System for up to 28 days.

Sponsors & Collaborators

  • Syntactx

    collaborator NETWORK

  • Molnlycke Health Care AB

    lead INDUSTRY

Principal Investigators

  • Hilde Beele, Prof. Dr. · University Hospital, Ghent

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-14
Primary Completion
2023-07-15
Completion
2023-07-21

Countries

  • Belgium
  • Denmark
  • France
  • Germany
  • Ireland
  • Italy
  • Portugal

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 NCT04753294 on ClinicalTrials.gov