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

Last updated: February 21, 2024
Sponsor: Contipro Pharma a.s.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Canker Sores

Mucositis

Treatment

Mucopad HA

Clinical Study ID

NCT06276270
PT-MUC-1_05-21
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 tounderstand and comply with the requirements of the study

Exclusion

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 inMedical Device
  • Alcohol or drug abuse

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Mucopad HA
Phase:
Study Start date:
December 12, 2023
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • Masarykův onkologický ústav, Klinika radiační onkologie

    Brno, Česká Republika 56401
    Czechia

    Active - Recruiting

  • FN Hradec Králové Klinika onkologie a radioterapie

    Hradec Králové, Česká Republika 56401
    Czechia

    Active - Recruiting

  • Fakultní nemocnice Ostrava, Klinika onkologická

    Ostrava, Česká Republika 56401
    Czechia

    Active - Recruiting

  • Etická komise FN Bulovka

    Praha, Česká Republika 56401
    Czechia

    Active - Recruiting

  • Fakultní Thomayerova nemocnice Onkologická klinika 1.LF UK a FTN

    Praha, Česká Republika 56401
    Czechia

    Active - Recruiting

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