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A Safety and Performance PMCF Investigation of the Avance® Solo NPWT System in Surgically Closed Incisions

NCT04894604 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2021-05-20

No results posted yet for this study

Summary

The ASOLO-SCI investigation is a Post Market Clinical Follow-up (PMCF) study to investigate the safety and performance of the Avance® Solo NPWT System in treating low to moderate exuding surgically closed incisions for up to 14 days when used in accordance with the Instructions for Use (IfU).

Conditions

  • Incision, Surgical
  • Surgical Incision
  • Surgical Wound
  • Surgical Wound, Recent
  • Surgical Wound Dehiscence

Interventions

DEVICE

Avance® Solo NPWT System

Application of the Avance® Solo NPWT System on up to 34 study Subjects, in accordance with the IfU for up to 14 days.

Sponsors & Collaborators

  • Syntactx

    collaborator NETWORK

  • Molnlycke Health Care AB

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-30
Primary Completion
2022-02-28
Completion
2022-03-31

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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 NCT04894604 on ClinicalTrials.gov