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

Contipro

Status

Enrolling

Conditions

Oral Mucositis

Treatments

Device: Mucopad HA

Study type

Interventional

Funder types

Other

Identifiers

NCT06276270

PT-MUC-1_05-21

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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