Chronic SinusitisEXCEEDNCT02228720
Clinical Evaluation of Propel Nova Sinus Implant in Peripheral Sinus Ostia
A study testing Propel Nova Sinus Implant in people with Chronic Sinusitis, run by Intersect ENT at 2 sites in United States.
Trial summary
This is a feasibility study is to assess the performance, safety and initial signals of efficacy of the drug-eluting Propel Nova Sinus Implant when used in chronic sinusitis patients undergoing sinus surgery of peripheral sinus ostia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Sinusitis
- What is being tested?
- Propel Nova Sinus Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2014to Jan 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patient is ≥ 18 years of age.
- Patient is willing and able to comply with protocol requirements.
- Patient has CS as confirmed by CT scan and defined as symptoms lasting longer than 8 consecutive weeks in duration with inflammation of the mucosa of the nose and paranasal sinuses.
- Patient's condition and the planned intervention will involve at least two and a maximum of four peripheral sinuses (frontal or maxillary sinuses or combination of both).
- Patient is a candidate for a planned intervention involving sinus surgery in the operating room or office setting.
- Patient has nasal polyps no greater than grade 2.
Show all 15Show fewer
- Patient with nasal polyps greater than 2 are eligible after their reduction/removal during ESS without significant complications that would confound the study results and leaving the patient's anatomy amenable to sinus implant placement, as judged by the operating physician.
- Female patients of child-bearing potential must not be pregnant and must agree to not become pregnant during the course of the study.
- Female patients of child-bearing potential must agree to use consistent and acceptable method/s of birth control during the course of the study.
- CS diagnosis confirmed and documented by CT Scan within 6 months of the procedure.
- Patient has a minimum total CT stage (Lund-Mackay method) of 6.
- Patient has disease in frontal and/or maxillary sinuses confirmed by CT scan.
- Planned ESS includes bilateral ethmoidectomy (if judged necessary), frontal sinus surgery using Draf II (A or B) dissection and/or balloon dilation, with minimum of 5-mm diameter opening created. In the case of maxillary sinus surgery, traditional antrostomy or balloon dilation, with or without removal of uncinate process, should be performed with minimum of 5-mm diameter opening created.
- Technique used for frontal or maxillary sinus surgery was the same on both sides (e.g. surgical dissection alone bilaterally, balloon dilation alone bilaterally, or both bilaterally)
- Septoplasty for access to the ostio-meatal complex is permitted.
Who cannot join
- Patient has presence of grade 3 or 4 polyposis, unless removed during surgery and preceding implant placement.
- Patient has presence of adhesions/scarring grades 3 or 4, unless removed during surgery and preceding implant placement.
- Patient has known history of immune deficiency (e.g., IGG subclass deficiency or IGA deficiency, HIV).
- Patient has concurrent condition requiring active chemotherapy and/or immunotherapy management for the disease (e.g., cancer, HIV, etc.).
- Patient has oral-steroid dependent condition such as COPD, asthma or other condition.
- Patient has known history of allergy or intolerance to corticosteroids or mometasone furoate.
Show all 16Show fewer
- Patient has clinical evidence of acute bacterial sinusitis (e.g. acute increase in purulent discharge, fever, facial pain etc.).
- Patient has clinical evidence or suspicion of invasive fungal sinusitis (e.g. bone erosion on prior CT scan, necrotic sinus tissue, etc.).
- Patient has evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments during the 90-day period.
- Patient is currently participating in another clinical trial.
- Patient has history of insulin dependent diabetes mellitus.
- Patient has previously undergone ESS and experienced a CSF leak or has residual compromised vision as a result of a complication in a prior ESS procedure.
- Patient has known dehiscence of the lamina papyracea.
- Patient has evidence of active viral illness (e.g., tuberculosis, ocular herpes simplex, chickenpox or measles).
- Significant complication during the current peripheral ostia surgery/such as excessive blood loss, CSF leak or punctured lamina papyracea.
- Current surgical intervention (operating room or office setting) is aborted for any reason.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ohio Sinus Institute
Dublin, Ohio, 43016
South Florida ENT Associates
Miami, Florida, 33176
About this study
Official title: The EXCEED Study: A Clinical Evaluation of the Drug-Eluting Propel Nova Sinus Implant When Placed in Peripheral Sinus Ostia to Maintain Patency
This is a feasibility study is to assess the performance, safety and initial signals of efficacy of the drug-eluting Propel Nova Sinus Implant when used in chronic sinusitis patients undergoing sinus surgery of peripheral sinus ostia.
Read the detailed description
This is a prospective, single-center, single-arm, open label feasibility study aiming to enroll at least 10 patients and a maximum of 15 patients to achieve 30 treated sinuses. The objective of this feasibility study is to assess the performance, safety and initial signals of efficacy of the drug-eluting Propel Nova Sinus Implant when used in chronic sinusitis (CS) patients undergoing sinus surgery of peripheral sinus ostia.
- Conditions
- Chronic Sinusitis
- Being tested
- Propel Nova Sinus Implant
- Keywords
- Chronic Sinusitis, Endoscopic Sinus Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propel Nova Sinus ImplantDevice
Also called Propel Contour Sinus Implant (mometasone furoate, 370 mcg)
Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate released over 30 days
| Study group | Role | What they receive |
|---|---|---|
| Propel Nova Sinus Implant | Experimental | Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate released over 30 days Receives: Device: Propel Nova Sinus Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Placement Success Rate
Defined as successful access to and placement of the Propel Nova Sinus Implant in the frontal or maxillary sinus ostium within two attempts. Calculated as a proportion where the numerator is the number of successful device placements and the denominator is the number of attempted sinuses.
Measured: Baseline Procedure
Secondary outcomes (4)
Ostial Patency
Ostial patency grading scale from 0 (patent) to 1 (Occluded/Restenosed)
Measured: Baseline, Day 30, Day 90
Adhesion/Scarring Grade 2 & 3
Adhesion/scarring grading scale from 0 (No visible granulation/scarring), 1 (Minimal amount of scarring/contraction observed but non-obstructing the frontal or maxillary sinus ostium), 2 (moderate amount of obstructive scar tissue/contraction present in the frontal or maxillary sinus ostium), 3 (Significant scar tissue/ contraction causing obstruction of the frontal or maxillary sinus ostium)
Measured: Baseline, Day 30, Day 90
Degree of Inflammation
Inflammation visual analog scale (VAS) from 0 (no visible inflammation) to 100 (severe inflammation, involving significant and extensive erythema and edema and/or hypertrophy and/or polypoid changes)
Measured: Baseline, Day 30, Day 90
Sino-Nasal Outcome Test (SNOT) 22
Validated, disease-specific, symptom-scoring instrument consisting of 22 questions, each scored by the patient on a scale of 0 (no problem) to 5 (problem as bad as it can be), resulting in a maximum total score of 110
Measured: Baseline, Day 30, Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2014 (estimated)
- Study startJun 2014
- Primary completionOct 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic SinusitisStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Propel Nova Sinus Implant
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intersect ENT
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William J. Brown, MD, Principal investigator, South Florida ENT Associates, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02228720
- Sponsor's protocol ID
- P500-0414
- Acronym
- EXCEED
- Status last verified
- Apr 2017
- First submitted
- 25 Jun 2014
- Last updated
- 4 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The EXCEED Study: A Clinical Evaluation of the Drug-Eluting Propel Nova Sinus Implant When Placed in Peripheral Sinus Ostia to Maintain Patency
- ClinicalTrials.gov ID
- NCT02228720
- Acronym / sponsor ID
- EXCEED / P500-0414
- Conditions
- Chronic Sinusitis
- Keywords
- Chronic Sinusitis, Endoscopic Sinus Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Intersect ENTIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 29 Aug 2014 (estimated)
- Results
- Posted 4 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a feasibility study is to assess the performance, safety and initial signals of efficacy of the drug-eluting Propel Nova Sinus Implant when used in chronic sinusitis patients undergoing sinus surgery of peripheral sinus ostia.
Detailed description
This is a prospective, single-center, single-arm, open label feasibility study aiming to enroll at least 10 patients and a maximum of 15 patients to achieve 30 treated sinuses. The objective of this feasibility study is to assess the performance, safety and initial signals of efficacy of the drug-eluting Propel Nova Sinus Implant when used in chronic sinusitis (CS) patients undergoing sinus surgery of peripheral sinus ostia.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Propel Nova Sinus Implant
| Arm | Type | Receives |
|---|---|---|
| Propel Nova Sinus Implant | Experimental | Device: Propel Nova Sinus ImplantBioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate released over 30 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patient is ≥ 18 years of age.
- Patient is willing and able to comply with protocol requirements.
- Patient has CS as confirmed by CT scan and defined as symptoms lasting longer than 8 consecutive weeks in duration with inflammation of the mucosa of the nose and paranasal sinuses.
- Patient's condition and the planned intervention will involve at least two and a maximum of four peripheral sinuses (frontal or maxillary sinuses or combination of both).
- Patient is a candidate for a planned intervention involving sinus surgery in the operating room or office setting.
Key exclusion criteria (16 listed)
- Patient has presence of grade 3 or 4 polyposis, unless removed during surgery and preceding implant placement.
- Patient has presence of adhesions/scarring grades 3 or 4, unless removed during surgery and preceding implant placement.
- Patient has known history of immune deficiency (e.g., IGG subclass deficiency or IGA deficiency, HIV).
- Patient has concurrent condition requiring active chemotherapy and/or immunotherapy management for the disease (e.g., cancer, HIV, etc.).
- Patient has oral-steroid dependent condition such as COPD, asthma or other condition.
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 |
|---|---|---|
| Propel Nova Sinus ImplantAlso: Propel Contour Sinus Implant (mometasone furoate, 370 mcg)Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate released over 30 days | Device | Propel Nova Sinus Implant |
Primary outcome
Device Placement Success Rate
Time frame: Baseline Procedure
Defined as successful access to and placement of the Propel Nova Sinus Implant in the frontal or maxillary sinus ostium within two attempts. Calculated as a proportion where the numerator is the number of successful device placements and the denominator is the number of attempted sinuses.
4 secondary outcomes
Ostial Patency
Time frame: Baseline, Day 30, Day 90
Adhesion/Scarring Grade 2 & 3
Time frame: Baseline, Day 30, Day 90
Degree of Inflammation
Time frame: Baseline, Day 30, Day 90
Sino-Nasal Outcome Test (SNOT) 22
Time frame: Baseline, Day 30, Day 90
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Chronic Sinusitis
RecruitingPhase 4
Biologics in Chronic Rhinosinusitis With Nasal Polyposis
Chronic Sinusitis, Nasal Polyps
Active, not recruitingPhase 3
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
Chronic Rhinosinusitis With Nasal Polyps
Active, not recruitingPhase 3
Clinical Trial of TQC2731 Injection in Patients With Chronic Sinusitis and Nasal Polyps
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Not yet recruiting
FESS With or Without Intranasal Desmopressin in Chronic Rhinosinusitis With Nasal Polyps
Chronic Sinusitis, Nasal Polyposis
Not yet recruiting
Effect of Probiotic Nasal Irrigation on the Postoperative Care of Chronic Rhinosinusitis
Sinusitis Chronic, Postoperative Care
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. This study is not recruiting at the moment.
William J. Brown, MD principal investigator
South Florida ENT Associates, PA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propel Nova Sinus Implant in people with Chronic Sinusitis, run by Intersect ENT at 2 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 15 inclusion and 16 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: finished, as of the sponsor's last update on 4 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Yes. Results are posted in the registry (first posted 4 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Device Placement Success Rate (time frame: Baseline Procedure). 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 4 Aug 2017; AzTrials last refreshed its copy on 7 Nov 2026.