Chronic SinusitisCONSENSUS IINCT00840970
A Clinical Evaluation of the Sinexus Intranasal Splint Following Functional Endoscopic Sinus Surgery in Patients With Chronic Rhinosinusitis
A study testing non-coated Intranasal Splint and Sinexus Intranasal Splint in people with Chronic Sinusitis, run by Intersect ENT at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety and performance of the Sinexus Intranasal Splint when used following Functional Endoscopic Sinus Surgery (FESS) in patients with Chronic Rhinosinusitis. 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?
- non-coated Intranasal Splint and Sinexus Intranasal Splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Apr 2009
- 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 or older.
- Patient has a diagnosis of bilateral CRS defined as inflammation of the mucosa of the nose and paranasal sinuses of at least 12 consecutive weeks' duration.
- Patient has a clinical indication for and has consented to bilateral FESS.
- CRS diagnosis documented by CT scan within 60 days of the procedure.
- Patient has minimal total CT stage (Lund-Mackay method) of 6.
- Patient has bilateral disease defined as minimal CT stage per side of ≥3.
Who cannot join
- Oral-Steroid dependent COPD, asthma or other condition.
- Immune deficiency (IGG subclass deficiency or IGA deficiency).
- Symptomatic coronary artery disease.
- Patient undergoing chemotherapy treatment.
- Morbid obesity (BMI > 40) or a BMI that, in the opinion of the physician, would compromise health and participation in the study.
- Evidence of active infection.
Trial locations and contacts
1 site in 1 country.
United States1 site
Central California Ear, Nose, Throat
Fresno, California, 93720
About this study
Official title: A Clinical Evaluation of the Steroid-Eluting Sinexus Intranasal Splint Used Following Functional Endoscopic Sinus Surgery (FESS) in Patients With Chronic Rhinosinusitis (CRS)
The purpose of this study is to assess the safety and performance of the Sinexus Intranasal Splint when used following Functional Endoscopic Sinus Surgery (FESS) in patients with Chronic Rhinosinusitis.
Read the detailed description
This was a prospective, multi-center, double blind trial that enrolled patients in three groups as described below. Two groups (Pilot 15 mm and Efficacy 25 mm) used a randomized, double-blind, intra-patient control study design to assess performance of the drug-coated Splint (received in one ethmoid sinus) compared to the control Splint (received in the contralateral ethmoid). The other group of patients (Safety/PK 25 mm) received bilateral drug-coated Splints, and served as a pharmacokinetics (PK) study group.
- Conditions
- Chronic Sinusitis
- Being tested
- non-coated Intranasal Splint, Sinexus Intranasal Splint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-coated Intranasal SplintDevice
placement of non-coated intranasal splint following FESS
Sinexus Intranasal SplintDevice
placement of Sinexus Intranasal Splint placed following FESS
| Study group | Role | What they receive |
|---|---|---|
| Efficacy Unilateral Control | Active comparator | Non-coated splint placed unilaterally in the ethmoid sinus opening randomized to receive the active comparator following FESS (control arm) Receives: Device: non-coated Intranasal Splint |
| Efficacy Unilateral Treatment | Experimental | Drug-coated splint placed unilaterally in the ethmoid sinus opening randomized to receive the intervention following FESS (treatment arm) Receives: Device: Sinexus Intranasal Splint |
| Safety/PK Bilateral Treatment | Experimental | Drug-coated splints placed bilaterally in both ethmoid sinus openings following FESS Receives: Device: Sinexus Intranasal Splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Success Rate
Device success rate defined as a ratio where the numerator is the number of successful deployments of the Sinexus Intranasal Splint and the denominator is the number of attempted sinuses. Deployment was considered successful if the implant procedure concluded with a successful splint placement on the intended side.
Measured: Baseline
Reduction in Ethmoid Sinus Inflammation
Inflammation was scored by the physician using a 100-mm Visual Analog Scale (VAS) during endoscopic evaluation with range of 0 to 100mm. The term inflammation was used as a global descriptor defined to include mucosal edema, erythema, hypertrophy and polypoid changes. 0 represented no inflammation and 100mm was defined as "Severe, involving significant and extensive erythema and edema and/or hypertrophy and/or polypoid changes".
Measured: 21 days
Secondary outcomes (4)
Middle Turbinate Lateralization
Position of the middle turbinate was assessed using a 4-point categorical scale (medialized, normal, partially lateralized, lateralized). For Lateralized Middle Turbinate, a sinus is counted once if this occurs at least once during the 30 Day timeframe. Lateralized Middle Turbinate (worse outcome), if left unaddressed, is often the cause of sinus obstruction.
Measured: 30 days
Middle Meatus Patency
Patency of the middle meatus was assessed using a 3-point categorical scale (patent, narrowed, obstructed). Analysis included patent (better outcome) vs narrowed/obstructed (worse outcome).
Measured: 30 days
Significant Adhesion Occurrence
Adhesion formation was assessed using a 5-point categorical scale (none, small/non-obstructing, obstructing/easily separated, *dense/obstructing/difficult to separate, *severe/complete adhesion to lateral nasal wall) with "significant adhesion" denoted by *
Measured: 30 days
Polypoid Tissue Changes
Polyp formation in the ethmoid sinus assessed using an accepted 5-point categorical scale: 0-no visible nasal polyp (NP), 1-small amount NP confined in the middle meatus (MM); 2-multiple NP confined in MM; 3-NP extending beyond MM, within the sphenoethmoid recess not totally obstructing, or both; 4-NP completely obstructing the nasal cavity. 0 is best, and 4 is worst. When a patient's sinus has a change in polyp score at Day 30 it is counted as one.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2009 (estimated)
- Study startMar 2008
- Primary completionMar 2009
- Study completionApr 2009
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intra-patient control where one ethmoid sinus was randomized to receive the intervention (treatment arm) while the contralateral ethmoid received the active comparator (control arm)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intersect ENT
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brent Lanier, MD, Principal investigator, Central California Ear, Nose, Throat
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00840970
- Sponsor's protocol ID
- P500-0208
- Acronym
- CONSENSUS II
- Status last verified
- Sep 2020
- First submitted
- 9 Feb 2009
- Last updated
- 1 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of the Steroid-Eluting Sinexus Intranasal Splint Used Following Functional Endoscopic Sinus Surgery (FESS) in Patients With Chronic Rhinosinusitis (CRS)
- ClinicalTrials.gov ID
- NCT00840970
- Acronym / sponsor ID
- CONSENSUS II / P500-0208
- Conditions
- Chronic Sinusitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Intersect ENTIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 11 Feb 2009 (estimated)
- Results
- Posted 1 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and performance of the Sinexus Intranasal Splint when used following Functional Endoscopic Sinus Surgery (FESS) in patients with Chronic Rhinosinusitis.
Detailed description
This was a prospective, multi-center, double blind trial that enrolled patients in three groups as described below. Two groups (Pilot 15 mm and Efficacy 25 mm) used a randomized, double-blind, intra-patient control study design to assess performance of the drug-coated Splint (received in one ethmoid sinus) compared to the control Splint (received in the contralateral ethmoid). The other group of patients (Safety/PK 25 mm) received bilateral drug-coated Splints, and served as a pharmacokinetics (PK) study group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Intra-patient control where one ethmoid sinus was randomized to receive the intervention (treatment arm) while the contralateral ethmoid received the active comparator (control arm)
| Arm | Type | Receives |
|---|---|---|
| Efficacy Unilateral Control | Active comparator | Device: non-coated Intranasal SplintNon-coated splint placed unilaterally in the ethmoid sinus opening randomized to receive the active comparator following FESS (control arm) |
| Efficacy Unilateral Treatment | Experimental | Device: Sinexus Intranasal SplintDrug-coated splint placed unilaterally in the ethmoid sinus opening randomized to receive the intervention following FESS (treatment arm) |
| Safety/PK Bilateral Treatment | Experimental | Device: Sinexus Intranasal SplintDrug-coated splints placed bilaterally in both ethmoid sinus openings following FESS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient is 18 years of age or older.
- Patient has a diagnosis of bilateral CRS defined as inflammation of the mucosa of the nose and paranasal sinuses of at least 12 consecutive weeks' duration.
- Patient has a clinical indication for and has consented to bilateral FESS.
- CRS diagnosis documented by CT scan within 60 days of the procedure.
- Patient has minimal total CT stage (Lund-Mackay method) of 6.
Key exclusion criteria (6 listed)
- Oral-Steroid dependent COPD, asthma or other condition.
- Immune deficiency (IGG subclass deficiency or IGA deficiency).
- Symptomatic coronary artery disease.
- Patient undergoing chemotherapy treatment.
- Morbid obesity (BMI > 40) or a BMI that, in the opinion of the physician, would compromise health and participation in the study.
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 |
|---|---|---|
| non-coated Intranasal Splintplacement of non-coated intranasal splint following FESS | Device | Efficacy Unilateral Control |
| Sinexus Intranasal Splintplacement of Sinexus Intranasal Splint placed following FESS | Device | Efficacy Unilateral Treatment, Safety/PK Bilateral Treatment |
Primary outcome
Device Success Rate
Time frame: Baseline
Device success rate defined as a ratio where the numerator is the number of successful deployments of the Sinexus Intranasal Splint and the denominator is the number of attempted sinuses. Deployment was considered successful if the implant procedure concluded with a successful splint placement on the intended side.
Reduction in Ethmoid Sinus Inflammation
Time frame: 21 days
Inflammation was scored by the physician using a 100-mm Visual Analog Scale (VAS) during endoscopic evaluation with range of 0 to 100mm. The term inflammation was used as a global descriptor defined to include mucosal edema, erythema, hypertrophy and polypoid changes. 0 represented no inflammation and 100mm was defined as "Severe, involving significant and extensive erythema and edema and/or hypertrophy and/or polypoid changes".
4 secondary outcomes
Middle Turbinate Lateralization
Time frame: 30 days
Middle Meatus Patency
Time frame: 30 days
Significant Adhesion Occurrence
Time frame: 30 days
Polypoid Tissue Changes
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
Brent Lanier, MD principal investigator
Central California Ear, Nose, Throat
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-coated Intranasal Splint and Sinexus Intranasal Splint in people with Chronic Sinusitis, run by Intersect ENT at 1 site 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 6 inclusion and 6 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 1 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 Oct 2020). 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 Success Rate (time frame: Baseline). 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 1 Oct 2020.