Multi-centre, Open-label, First-in-man Study With Mucopad HA
NCT06276270 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2026-03-20
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.
Conditions
- Oral Mucositis
Interventions
- DEVICE
-
Mucopad HA
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.
Sponsors & Collaborators
-
Contipro Pharma a.s.
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-12-12
- Primary Completion
- 2024-11-30
- Completion
- 2024-11-30
Countries
- Czechia
Study Locations
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