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

Launched by CONTIPRO PHARMA A.S. · Feb 21, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a device called Mucopad HA, which is designed to help treat oral mucositis—a painful condition that can occur in the mouth, often after cancer treatments like radiotherapy. The purpose of the trial is to ensure that this device is safe to use for patients experiencing lesions or sores in their mouths. The trial is currently recruiting participants aged 18 and older who have been diagnosed with oral mucositis of varying severity and are willing to provide their consent to take part in the study.

Eligible participants will receive the Mucopad HA treatment and will be monitored for safety and effectiveness. It's important to note that individuals who are pregnant, have severe allergies to any materials in the device, or are in the final stages of a serious illness are not able to participate. This study aims to gather valuable information that could improve the management of oral mucositis, making it easier for patients to cope with this challenging condition.

Gender

ALL

Eligibility criteria

• 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