CompletedNot Applicable

Multi-centre, Open-label, First-in-man Study With Mucopad HA

Czechia50 participantsStarted 2023-12-12

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Resolution of mucositis symptoms since completion of radiotherapy

Timeframe: 10 weeks

Trial details

NCT IDNCT06276270

SponsorContipro Pharma a.s.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-30

View on ClinicalTrials.gov More Oral Mucositis trials