NCT07286201

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

A Multicenter, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of a Bioresorbable Nasal Dressing Containing Mometasone Furoate Compared to a Steroid-eluting Sinus Stent

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Polyganics BV · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A multicenter, randomized, single-blinded, controlled, intra-patient non-inferiority study enrolling 110 subjects at up to 13 sites in the United States.

Conditions

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

Interventions

Type	Name	Description
DEVICE	OCEAN	Biodegradable nasal dressing applied after sinus/nasal surgery
DEVICE	Steroid-eluting sinus stent	Applied after sinus/nasal surgery

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2025-12-16
• Last updated: 2025-12-16

Regulatory

• FDA-regulated device study