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| Name | Class |
|---|---|
| Syntactx | NETWORK |
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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.
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 chronic wounds. This is a multi-center study that will take place in approximately 5 European countries. The target subjects are male or female, 18 years or older with low to moderate exuding chronic wounds (pressure ulcers (N=68), diabetic foot ulcers (N=34), and venous leg ulcers (N=34)) suitable for NPWT as deemed by the investigator. Two different options of Negative Pressure Wound Therapies (NPWT) will be evaluated through this clinical investigation
A total of 136 subjects will receive treatment with the investigational devices within the intended use according to Instructions for Use (IfU): Group 1: 102 subjects in total, 34 subjects per indication (pressure ulcers, diabetic foot ulcers, and venous leg ulcers) treated with Avance®Solo and Group 2: 34 subjects with pressure ulcers treated with Avance®Solo Adapt. Subjects will be managed and monitored for a maximum of 4 weeks or until withdrawal from investigation for any reason.
The primary performance endpoint will include assessment of wound progress compared to last visit during a maximum 28 days investigation period. Wound progression is determined by the Investigator and will take into account all aspects of wound characteristics. Wound progression will be assessed by the Investigator at each follow-up visit and measured by three outcomes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Avance Solo NPWT System | Experimental | Treatment with negative pressure wound therapy for Venous leg ulcers, Diabetic foot ulcers, and Pressure ulcers. |
|
| Avance Solo Adapt NPWT System | Experimental | Treatment with negative pressure wound therapy for Pressure ulcers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avance Solo NPWT System | Device | Wound treatment with Avance Solo NPWT System for up to 28 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in wound progress | Wound progress compared to last visit and assessed as:
| Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Wound progress | Wound progress compared between baseline and final visit and assessed as:
| 28 days |
| Absolute change in wound area | Absolute change in wound area from baseline to all follow-up visits |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hilde Beele, Prof. Dr. | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diensthoofd wondkliniek, UZ Gent | Ghent | 9000 | Belgium | |||
| AZ Delta |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 25, 2026 | |
| Reset | Apr 13, 2026 |
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Four different patient groups treated with the Avance Solo NPWT System or Avance Solo Adapt NPWT System.
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| Avance Solo Adapt NPWT System | Device | Wound treatment with Avance Solo Adapt NPWT System for up to 28 days. |
|
| Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days) |
| Absolute change in wound volume | Absolute change in wound volume from baseline to all follow-up visits | Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days) |
| Percentage change in wound area | Percentage change in wound area from baseline to all follow-up visits | Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days) |
| Percentage change in wound volume | Percentage change in wound volume from baseline to all follow-up visits | Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days) |
| Tissue type | Change in tissue type (slough, necrotic, granulation or epithelization) from baseline to all follow-up visits. | Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days) |
| Exudate amount | Change in exudate amount using a category scoring system from baseline to all follow-up visits. Amount: none, low, moderate, or high) | Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days) |
| Exudate nature | Change in exudate nature using a category scoring system from baseline to all follow-up visits. Nature: serous, fibrinous, serosanguineous, sanguineous, seropurulent, purulent, foul purulent, heamopurulent, or hemorrhagic | Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days) |
| Exudate odor | Change in exudate odor using a category scoring system from baseline to all follow-up visits. Odor: no odor, slight, moderate, strong, and very strong | Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days) |
| Peri-wound | Change in peri-wound skin condition from baseline to all follow-up visits using the following conditions:
| Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days) |
| Tissue in-growth | Degree of tissue in-growth when Avance Solo foam is utilized at all follow-up visits as well as extra visits. | Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days) with additional assessments in between when dressing is changed |
| Pain assessment | Subject evaluation of pain at Avance Solo dressing or Avance Solo Adapt Film removal using Numeric Rating Scale (NRS) at each follow-up visit. | Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days) |
| Trauma | Proportion of subjects with trauma to the wound site and surrounding skin for Avance Solo Border Dressing, fixation strips or Avance Solo Adapt Film at all follow-up visits. | Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days) |
| Quality of life assessed using Numeric Rating Scale (NRS) | Impact of everyday life by the systems will be captured through a NRS scale where the subject grade how much the treatment has affected the subject's daily life. 0 is equal to no influence and 10 to considerable influence on everyday life or unbearable. If replying >0, the subject will state the presence or absence of the following causes:
| 28 days |
| Alarms | Subject evaluation of the system properties (number of sounding alarms) assessed with a given scale at all follow-up visits
| Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days) |
| Compliance | Evaluate the compliance to the provided therapy by average number of hours per 24h that the system has not provided treatment since last visit. | Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days) |
| Ability to absorb and/or transport exudate via clinical judgement | Evaluation of the Systems ability to absorb and/or transport exudate assessed using a rating scale by the clinician/designee:
| Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days) |
| Ease of application | Clinician evaluation of ease of application and removal of Avance®Solo or Avance®Solo Adapt using a Numeric Rating Scale (NRS) collected at baseline, and each follow-up visit. | Baseline, Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days) |
| Global satisfaction | Evaluate the investigator and subject global satisfaction of the systems in regards to:
| 28 days |
| Product consumption | Product consumption of the utilized products for the system's, from baseline and final visit using the Avance Solo or Avance Solo Adapt NPWT System | Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days) |
| Wear time | Evaluate Avance®Solo or Avance®Solo Adapt wear time in days from baseline to all follow-up visits including potential extra visits | Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days) |
| Roeselare |
| 8800 |
| Belgium |
| North Zeeland Hospital | Hillerød | 3400 | Denmark |
| CHU Montpellier | Montpellier | 34295 | France |
| Franziskus-Krankenhaus Berlin | Berlin | 10787 | Germany |
| Klinik fur Dermatologie, Venerologie und Allergologie Campus Benjamin Franklin | Berlin | 12200 | Germany |
| Klinikum der Ruhr-Universität Bochum | Bochum | 44791 | Germany |
| St James's Hospital | Dublin | D08 NHY1 | Ireland |
| Ospedale San Raffaele S.r.I. | Milan | 20132 | Italy |
| A.O.U. Citta della Salute e della Scienza di Torino - A.O.U. Molinette San Giovanni Battista | Torino | 10126 | Italy |
| Santa casa da Misericórdia de Aveiro | Aveiro | Portugal |
| Unidade de Cuidados Continuados António Francisco Guimarães | Guimarães | Portugal |
| Trofa Saúde Hospital Central Hospital da Trofa | Touguinho | Portugal |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 25, 2026 | Apr 13, 2026 |
| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| D003668 | Pressure Ulcer |
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D003925 | Diabetic Angiopathies |
| D016523 | Foot Ulcer |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
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