Evaluation of the Safety and Performance of a Bioresorbable Nasal Dressing Containing Mometasone Furoate
NCT06642116 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2024-10-15
Summary
The objective of this study is to investigate the safety and performance of OCEAN® as an adjunct in wound healing after nasal/sinus surgery by using OCEAN® in patients undergoing nasal/sinus surgery.
Conditions
- Rhinosinusitis Chronic
- Wound Healing
- Sinus Surgery
- Mometasone Furoate
Interventions
- DEVICE
-
OCEAN
Biodegradable nasal dressing
Sponsors & Collaborators
-
NAMSA
collaborator OTHER -
Polyganics BV
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- DEVICE_FEASIBILITY
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-11-30
- Primary Completion
- 2025-05-31
- Completion
- 2025-07-31
- FDA Device
- Yes
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