Status:
COMPLETED
Confirm Safety and Performance of Avance Solo and Avance Solo Adapt NPWT Systems
Lead Sponsor:
Molnlycke Health Care AB
Collaborating Sponsors:
Syntactx
Conditions:
Venous Leg Ulcer
Pressure Ulcer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
This investigation is designed as a prospective, open and non-comparative PMCF investigation to confirm the safety and performance of Avance®Solo and Avance®Solo Adapt in low to moderate exuding chron...
Eligibility Criteria
Inclusion
- Male or female ≥ 18 years.
- Signed written informed consent.
- Low to moderate exuding chronic wounds (diabetic foot ulcers, venous leg ulcers and pressure ulcers for Avance®Solo or pressure ulcers for Avance®Solo Adapt) suitable for NPWT according to the investigator´s judgement and Instructions for Use.
- Subjects that will be capable and willing to comply with protocol instructions
Exclusion
- Known malignancy in the wound or margins of the wound
- Untreated and previously confirmed osteomyelitis
- Non-enteric and unexplored fistulas
- Necrotic tissue with eschar present
- Exposed nerves, arteries, veins or organs
- Exposed anastomotic site
- Known allergy/hypersensitivity to the dressing or its components.
- Known pregnancy or planning to become pregnant or lactation at time of study participation.
- Participation in another investigative drug or device trial currently or within the last 30 days Subjects not suitable for the investigation according to the Investigator's judgement, Clinical Investigation Plan and Instructions for Use
Key Trial Info
Start Date :
June 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 21 2023
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT04753294
Start Date
June 14 2021
End Date
July 21 2023
Last Update
September 8 2023
Active Locations (13)
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1
Diensthoofd wondkliniek, UZ Gent
Ghent, Belgium, 9000
2
AZ Delta
Roeselare, Belgium, 8800
3
North Zeeland Hospital
Hillerød, Denmark, 3400
4
CHU Montpellier
Montpellier, France, 34295