Multi-centre, Open-label, First-in-man Study With Mucopad HA
NCT ID: NCT06276270
Last Updated: 2024-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2023-12-12
2024-12-31
Brief Summary
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Detailed Description
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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 [email protected].
List of investigational sites is in appendix 7.
Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Device is administered directly onto the area affected by mucositis.
Mucopad HA
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.
Interventions
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Mucopad HA
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.
Eligibility Criteria
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Inclusion Criteria
* Oral Mucositis after radiotherapy of grade I - IV according to WHO
* Patient willing and able to provide the written consent
* Ability to communicate well with the investigator in the local language, and to understand and comply with the requirements of the study
Exclusion Criteria
* Pregnant or lactating women
* Patients in terminal stage of living
* Patients with known hypersensitivity or allergy to any of the substances contained in Medical Device
* Alcohol or drug abuse
18 Years
ALL
No
Sponsors
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Contipro Pharma a.s.
OTHER
Responsible Party
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Locations
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Masarykův onkologický ústav, Klinika radiační onkologie
Brno, Česká Republika, Czechia
FN Hradec Králové Klinika onkologie a radioterapie
Hradec Králové, Česká Republika, Czechia
Fakultní nemocnice Ostrava, Klinika onkologická
Ostrava, Česká Republika, Czechia
Etická komise FN Bulovka
Prague, Česká Republika, Czechia
Fakultní Thomayerova nemocnice Onkologická klinika 1.LF UK a FTN
Prague, Česká Republika, Czechia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PT-MUC-1_05-21
Identifier Type: -
Identifier Source: org_study_id
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