Oral Mucositis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEMucopad 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.
Sponsors
Contipro Pharma a.s.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * 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
* Age \< 18 years * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resolution of mucositis symptoms since completion of radiotherapy | 10 weeks | healing time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| - Pain management (VAS scale) | 10 weeks | pain value 1-100 |
| Development of xerostomy | 10 weeks | xerostomy yes/no |
| Subjective evaluation on scale 1-5 of the treatment by investigator/ patient | 10 weeks | scale 1-5 |
Countries
Czechia
Outcome results
None listed