Evaluation of the Safety and Performance of a Bioresorbable Nasal Dressing Containing Mometasone Furoate
NCT ID: NCT06642116
Last Updated: 2024-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
20 participants
INTERVENTIONAL
2024-11-30
2025-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of the Safety and Performance of a Bioresorbable Nasal Dressing Containing Mometasone Furoate (MF)
NCT07286201
Comparison of Daily Mometasone Furoate Nasal Spray Alone Versus a Combination With Montelukast for Treatment of Chronic Rhinosinusitis With Asthma After Functional Endoscopic Sinus Surgery
NCT02110654
A Study of the Effectiveness and Safety of Mometasone Furoate Nasal Spray (MFNS, SCH 032088) for the Treatment of Nasal Polyps (P05604)
NCT01386125
Mometasone Furoate Nasal Spray for Treatment of Nasal Polyposis After Surgery (Study P03218)
NCT00731185
Study of Nasonex® for the Treatment of Nasal Polyps in Pediatric Subjects Between Ages of 6 and Less Than 18 Years Old (P04292)
NCT00378378
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
OCEAN
Application of OCEAN after nasal/sinus surgery
OCEAN
Biodegradable nasal dressing
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
OCEAN
Biodegradable nasal dressing
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patient is scheduled to undergo bilateral endoscopic sinus surgery for Chronic Rhinosinusitis with nasal polyps (CRSwNP) or Chronic Rhinosinusitis without nasal polyps (CRSsNP)
3. Patient is willing and able to comply with all study elements as indicated by their written informed consent
4. Patients with a pre-operative Lund-MacKay score of ≥ 6.
Exclusion Criteria
2. Patients with a history of chronic epistaxis or experienced a significant epistaxis event (defined as epistaxis requiring medical intervention) in the past 3 months
3. Patients with a platelet disorder
4. Patients with a known or suspected allergy to device components
5. Patients with known hemophilia
6. Patients with insulin dependent diabetics
7. Patients with an oral steroid dependent condition
8. Patients with glaucoma, ocular hypertension, posterior subcapsular cataracts
9. Patients with a (previous) diagnosis of Samter's Triad (aspirin-exacerbated respiratory disease (AERD))
10. Patients that require nasal ointments or creams at time of device placement
11. 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
12. Patients with plans to (or otherwise anticipate the need to) undergo an ear, nose, throat (ENT) procedure within the 90 day study follow up
13. Patients participating in another clinical research study (within 30 days prior to screening up till 90 days post-operative).
14. Patients that used any form of corticosteroid or immunologics within 2 weeks prior to sinus surgery or during follow-up to day 30.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
NAMSA
OTHER
Polyganics BV
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CIP-4
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.