Multi-centre, Open-label, First-in-man Study With Mucopad HA
1 other identifier
interventional
50
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2023
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 12, 2023
CompletedFirst Submitted
Initial submission to the registry
February 14, 2024
CompletedFirst Posted
Study publicly available on registry
February 23, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2024
CompletedMarch 20, 2026
March 1, 2026
12 months
February 14, 2024
March 18, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Resolution of mucositis symptoms since completion of radiotherapy
healing time
10 weeks
Secondary Outcomes (3)
- Pain management (VAS scale)
10 weeks
Development of xerostomy
10 weeks
Subjective evaluation on scale 1-5 of the treatment by investigator/ patient
10 weeks
Study Arms (1)
Device is administered directly onto the area affected by mucositis.
EXPERIMENTALInterventions
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Masarykův onkologický ústav, Klinika radiační onkologie
Brno, Česká Republika, 56401, Czechia
FN Hradec Králové Klinika onkologie a radioterapie
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2024
First Posted
February 23, 2024
Study Start
December 12, 2023
Primary Completion
November 30, 2024
Study Completion
November 30, 2024
Last Updated
March 20, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share