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Evaluation of the Safety and Performance of a Bioresorbable Nasal Dressing Containing Mometasone Furoate (MF)

NCT07286201 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2025-12-16

No results posted yet for this study

Summary

The primary objective of the study is to evaluate the safety and effectiveness of OCEAN as an adjunct aid in wound healing after nasal/sinus surgery and to demonstrate that OCEAN is non-inferior compared to a steroid-eluting sinus stent.

Conditions

  • Chronic Rhinosinusitis (CRS)
  • Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps

Interventions

DEVICE

OCEAN

Biodegradable nasal dressing applied after sinus/nasal surgery

DEVICE

Steroid-eluting sinus stent

Applied after sinus/nasal surgery

Sponsors & Collaborators

  • NAMSA

    collaborator OTHER

  • Polyganics BV

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2027-01-31
Completion
2027-01-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07286201 on ClinicalTrials.gov