Chronic Rhinosinusitis (CRS)ENHANCE IINCT07286201
Evaluation of the Safety and Performance of a Bioresorbable Nasal Dressing Containing Mometasone Furoate (MF)
A study testing OCEAN and Steroid-eluting sinus stent in people with Chronic Rhinosinusitis (CRS) and Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps, run by Polyganics BV at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinosinusitis (CRS), Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
- What is being tested?
- OCEAN and Steroid-eluting sinus stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 9 sitesUnited States
- Study dates
- 19 Mar 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is 18 years or older
- Subject is scheduled to undergo bilateral endoscopic sinus surgery for Chronic Rhinosinusitus with nasal polyps (CRSwNP) or without nasal polyps (CRSsNP) and is indicated for bilateral complete ethmoidectomy (anterior and posterior ethmoidectomy) at a minimum. Additional sinuses may be operated on at the surgeon's discretion.
- Subject is willing and able to provide informed consent.
- Subject is willing and able to comply with the investigational plan requirements.
- Subjects with a pre-operative Lund-MacKay stage of 6 (≥3 per nostril).
- Subject with a pre-operative Lund-Mackay stage side-to-side difference ≤ 2.
- Subject of child-bearing potential is not pregnant and agrees to not become pregnant during the course of the study.
Who cannot join
- Subject with a history of chronic epistaxis or experienced a significant epistaxis event (defined as epistaxis requiring medical intervention) in the past 3 months.
- Subject with an underlying systemic disorders known to affect the nose (e.g., Wegener's granulomatosis, sarcoidosis, Churg-Strauss syndrome, or other systemic vasculitides).
- Subject with any bleeding disorder or use of medication increasing bleeding risk, except low-dose aspirin.
- Subject with a known or suspected allergy to device components.
- Subject with known hemophilia.
- Subject with insulin dependent diabetes.
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- Subject with an oral steroid dependent condition.
- Subject with glaucoma, ocular hypertension, posterior subcapsular cataracts.
- Subject with a (previous) diagnosis of Samter's Triad (AERD).
- Subject that requires nasal ointments or creams at time of device placement.
- Subject with a neurological, medical, psychiatric condition, or social circumstance that would potentially increase risk, interfere with study participation, or confound interpretation of study data.
- Subject with plans to (or otherwise anticipate the need to) undergo an ENT procedure within the 90-day study follow-up.
- Subject participating in another clinical research study (within 30 days prior to screening up to 90 days post-operative).
- Subject that used any form of biologics within 90 days prior to sinus surgery and during follow-up to day 25.
- Subject that used any form of corticosteroid within 2 weeks prior to sinus surgery.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites
Emory University
Atlanta, Georgia, 30308
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Illinois at Chicago
Chicago, Illinois, 60612
Colorado ENT & Allergy
Colorado Springs, Colorado, 80923
University of Texas Health
Houston, Texas, 77030
Ogden Clinic
Ogden, Utah, 84403
ENT Allergy & Associates
Puyallup, Washington, 98374
Louisiana State University Health at Shreveport
Shreveport, Louisiana, 71103
Centers for Advanced ENT Care
Towson, Maryland, 21204
About this study
Official title: 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
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.
Read the 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.
- Being tested
- OCEAN, Steroid-eluting sinus stent
- Keywords
- Nasal Packing, Mometasone Furoate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCEANDevice
Biodegradable nasal dressing applied after sinus/nasal surgery
Steroid-eluting sinus stentDevice
Applied after sinus/nasal surgery
| Study group | Role | What they receive |
|---|---|---|
| OCEAN | Experimental | Application after nasal/sinus surgery Receives: Device: OCEAN |
| Steroid-eluting Sinus Stent | Active comparator | Application after nasal/sinus surgery Receives: Device: Steroid-eluting sinus stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Serious Adverse Events
Rate of serious adverse events related to the use of OCEAN bioresorbable nasal dressing.
Measured: Up to Day 25
Endoscopic Assessment
Endoscopic assessment of wound healing to compare test-treated and control-treated cavities.
Measured: Day 25
Secondary outcomes (3)
Rate of Adverse Events
Assessment of all adverse events.
Measured: Up to Day 90
Endoscopic Evaluation of Sinonasal Cavities
Endoscopic evaluation of sinonasal cavities for to evaluate wound healing.
Measured: Days 25 and 90
Rate of post-operative interventions
Rate of post-operative interventions, including surgical intervention to separate adhesions, and/or oral steroid intervention, and/or biologics.
Measured: Up to Day 25 and Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start19 Mar 2026
- Primary completionMar 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis (CRS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Intra-patient study design comparing test-treated to control-treated cavities.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Polyganics BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07286201
- Sponsor's protocol ID
- CIP-6
- Acronym
- ENHANCE II
- Status last verified
- Jun 2026
- First submitted
- 10 Dec 2025
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07286201
- Acronym / sponsor ID
- ENHANCE II / CIP-6
- Keywords
- Nasal Packing, Mometasone Furoate
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Polyganics BVIndustry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Study start
- 19 Mar 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Intra-patient study design comparing test-treated to control-treated cavities.
| Arm | Type | Receives |
|---|---|---|
| OCEAN | Experimental | Device: OCEANApplication after nasal/sinus surgery |
| Steroid-eluting Sinus Stent | Active comparator | Device: Steroid-eluting sinus stentApplication after nasal/sinus surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject is 18 years or older
- Subject is scheduled to undergo bilateral endoscopic sinus surgery for Chronic Rhinosinusitus with nasal polyps (CRSwNP) or without nasal polyps (CRSsNP) and is indicated for bilateral complete ethmoidectomy (anterior and posterior ethmoidectomy) at a minimum. Additional sinuses may be operated on at the surgeon's discretion.
- Subject is willing and able to provide informed consent.
- Subject is willing and able to comply with the investigational plan requirements.
- Subjects with a pre-operative Lund-MacKay stage of 6 (≥3 per nostril).
Key exclusion criteria (15 listed)
- Subject with a history of chronic epistaxis or experienced a significant epistaxis event (defined as epistaxis requiring medical intervention) in the past 3 months.
- Subject with an underlying systemic disorders known to affect the nose (e.g., Wegener's granulomatosis, sarcoidosis, Churg-Strauss syndrome, or other systemic vasculitides).
- Subject with any bleeding disorder or use of medication increasing bleeding risk, except low-dose aspirin.
- Subject with a known or suspected allergy to device components.
- Subject with known hemophilia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCEANBiodegradable nasal dressing applied after sinus/nasal surgery | Device | OCEAN |
| Steroid-eluting sinus stentApplied after sinus/nasal surgery | Device | Steroid-eluting Sinus Stent |
Primary outcome
Rate of Serious Adverse Events
Time frame: Up to Day 25
Rate of serious adverse events related to the use of OCEAN bioresorbable nasal dressing.
Endoscopic Assessment
Time frame: Day 25
Endoscopic assessment of wound healing to compare test-treated and control-treated cavities.
3 secondary outcomes
Rate of Adverse Events
Time frame: Up to Day 90
Endoscopic Evaluation of Sinonasal Cavities
Time frame: Days 25 and 90
Rate of post-operative interventions
Time frame: Up to Day 25 and Day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OCEAN and Steroid-eluting sinus stent in people with Chronic Rhinosinusitis (CRS) and Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps, run by Polyganics BV at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Serious Adverse Events (time frame: Up to Day 25). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.