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

NCT06642116 | Not Yet Recruiting FDA Device

• 1 other identifier: CIP-4
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (2)

• Safety

  Rate of serious adverse events related to the use of the OCEAN bioresorbable nasal dressing post nasal surgery

  Up to 25 days after surgery

• Performance

  Endoscopic evaluation of aspects of wound healing as assessed using the Lund-Kennedy Endoscopic Score System (LKS). The LKS assesses various factors like edema, crusting, discharge, polyps, and mucosal inflammation. Each parameter is scored from 0 to 2, with 0 being normal and 2 representing severe findings. Higher scores on the Lund-Kennedy Scale indicate a worse outcome, reflecting more severe disease or poor wound healing. Minimum Value: 0 (This represents no signs of inflammation or disease); Maximum Value: 20 (This indicates the most severe signs of disease or inflammation)

  Up to 25 days after surgery

Study Arms (1)

OCEAN

EXPERIMENTAL

Application of OCEAN after nasal/sinus surgery

Device: OCEAN

Interventions

OCEAN DEVICE

Biodegradable nasal dressing

OCEAN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is 18 years or older
• Patient is scheduled to undergo bilateral endoscopic sinus surgery for Chronic Rhinosinusitis with nasal polyps (CRSwNP) or Chronic Rhinosinusitis without nasal polyps (CRSsNP)
• Patient is willing and able to comply with all study elements as indicated by their written informed consent
• Patients with a pre-operative Lund-MacKay score of ≥ 6.

You may not qualify if:

• Patient is pregnant or nursing
• Patients with a history of chronic epistaxis or experienced a significant epistaxis event (defined as epistaxis requiring medical intervention) in the past 3 months
• Patients with a platelet disorder
• Patients with a known or suspected allergy to device components
• Patients with known hemophilia
• Patients with insulin dependent diabetics
• Patients with an oral steroid dependent condition
• Patients with glaucoma, ocular hypertension, posterior subcapsular cataracts
• Patients with a (previous) diagnosis of Samter's Triad (aspirin-exacerbated respiratory disease (AERD))
• Patients that require nasal ointments or creams at time of device placement
• Patients with a neurological, medical, psychiatric condition, or social circumstance that would potentially increase risk, interfere with study participation, or confound interpretation of study data
• Patients with plans to (or otherwise anticipate the need to) undergo an ear, nose, throat (ENT) procedure within the 90 day study follow up
• Patients participating in another clinical research study (within 30 days prior to screening up till 90 days post-operative).
• Patients that used any form of corticosteroid or immunologics within 2 weeks prior to sinus surgery or during follow-up to day 30.

Sponsors & Collaborators

• Polyganics BV: lead
• NAMSA: collaborator

Central Study Contacts

Carola Hartgers

CONTACT

050 588 6582; chartgers@regenity.com

Betty IJmker

CONTACT

050 588 6582; bijmker@regenity.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 15, 2024
• Study Start: November 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: July 1, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-09