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The device´s intended use is to treat defects and/or lesions of the oral mucosa, e.g. oral mucositis.To prove safety of the device in terms of clinical results.
This is an multi-centre, open-label, first-in-man prospective study.
Up to 60 patients in total will be involved in the open-label trial of new medical device - Mucopad HA. Eligible patients will be undergoing treatment with the device for up to 10 weeks, after which it is expected that there should be significant improvement in the healing process of oral mucositis after radiotherapy. It is considered as an improvement when there is a significant reduction or complete resolution of the mucositis. Mucositis will be assessed as a WHO scale.
Quality of life will be assessed by Oral Mucositis Daily Questionnaire (OMDQ) provided by FACIT. The FACIT and all related works are owned and copyrighted by, and the intellectual property of David Cella, Ph.D. Permission for use of the OMDQ questionnaire is obtained by contacting Dr. Cella at information@facit.org.
List of investigational sites is in appendix 7.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device is administered directly onto the area affected by mucositis. | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mucopad HA | Device | The product is a Class III Medical Device incorporating a medicinal substance (antiseptics-octenidine) within the composition made of sodium hyaluronate polysacharide stabilised by calcium chloride. Device is administered directly onto the area affected by mucositis. |
| Measure | Description | Time Frame |
|---|---|---|
| Resolution of mucositis symptoms since completion of radiotherapy | healing time | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| - Pain management (VAS scale) | pain value 1-100 | 10 weeks |
| Development of xerostomy | xerostomy yes/no | 10 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masarykův onkologický ústav, Klinika radiační onkologie | Brno | Česká Republika | 56401 | Czechia | ||
| FN Hradec Králové Klinika onkologie a radioterapie |
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| ID | Term |
|---|---|
| D013280 | Stomatitis |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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|
| Subjective evaluation on scale 1-5 of the treatment by investigator/ patient | scale 1-5 | 10 weeks |
| Hradec Králové |
| Česká Republika |
| 56401 |
| Czechia |
| Fakultní nemocnice Ostrava, Klinika onkologická | Ostrava | Česká Republika | 56401 | Czechia |
| Etická komise FN Bulovka | Prague | Česká Republika | 56401 | Czechia |
| Fakultní Thomayerova nemocnice Onkologická klinika 1.LF UK a FTN | Prague | Česká Republika | 56401 | Czechia |