Chronic SinusitisREMODELNCT01525849
Randomized Evaluation of Maxillary Antrostomy Versus Ostial Dilation Efficacy Through Long-Term Follow-Up
A study testing Balloon Sinus Dilation and Functional Endoscopic Sinus Surgery in people with Chronic Sinusitis, run by Entellus Medical, Inc. at 1 site in United States.
Trial summary
The objective of this study is to show that long-term symptom improvement after sinus balloon dilation is not worse than symptom improvement after functional endoscopic sinus surgery (FESS) and that fewer postoperative debridements are required after balloon dilation than after FESS. 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?
- Balloon Sinus Dilation and Functional Endoscopic Sinus Surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to May 2014
- 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
- 18 years or older
- maxillary sinus disease
- chronic sinusitis
Who cannot join
- fungal disease
- Samter's triad
- hemophilia
- prior sinus surgery
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to show that long-term symptom improvement after sinus balloon dilation is not worse than symptom improvement after functional endoscopic sinus surgery (FESS) and that fewer postoperative debridements are required after balloon dilation than after FESS.
Read the detailed description
This is a postmarket, multicenter, prospective, randomized clinical trial conducted at up to 15 US clinical sites comparing the efficacy of balloon sinus dilation with traditional endoscopic sinus surgery. The primary hypotheses were to demonstrate that: 1) long-term change in sinus symptoms after balloon dilation is not worse (non-inferior) than after FESS, and 2) balloon dilation is superior to FESS for a reduction in the number of postoperative debridements per patient. A minimum of 36 participants per arm is required to test the primary hypotheses. All participants will be followed through a minimum of 12 months post treatment.
- Conditions
- Chronic Sinusitis
- Being tested
- Balloon Sinus Dilation, Functional Endoscopic Sinus Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon Sinus DilationDevice
Balloon sinus dilation using the XprESS Multi-Sinus Dilation Tool or the FinESS SInus Treatment
Functional Endoscopic Sinus SurgeryProcedure or surgery
Endoscopic sinus surgery, specifically, maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy
| Study group | Role | What they receive |
|---|---|---|
| Balloon Sinus Dilation | Active comparator | XprESS Multi-Sinus Dilation Balloon, FinESS Sinus Treatment Receives: Device: Balloon Sinus Dilation |
| Functional Endoscopic Sinus Surgery | Active comparator | Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools. Receives: Procedure: Functional Endoscopic Sinus Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sinus Symptom Improvement
Change from baseline in overall 20-item Sino-Nasal Outcome Test (SNOT-20) score. The SNOT-20 is a validated patient reported survey of 20 items related to sinonasal symptoms and severity assessed over the previous 2 weeks. Each item is scored from 0 (no problem) to 5 (problem as bad as it can be). The individual item scores are averaged to provide and overall score that ranges from 0 (best) to 5 (worst).
Measured: Baseline and 1-year
Debridements
Number of postoperative debridements per participant
Measured: 1-year
Secondary outcomes (3)
Revision Rate
Number of participants requiring repeat sinus procedures
Measured: 1-year
Complication Rate
Number of participants experiencing 1 or more serious adverse events related to the device and/or procedure
Measured: Duration of study (minimum of 12 months)
Recovery Time
Mean time (days) after procedure for participants to return to normal activities
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2012 (estimated)
- Study startDec 2011
- Primary completionFeb 2014
- Study completionMay 2014
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.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Entellus Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01525849
- Sponsor's protocol ID
- 1984-001
- Acronym
- REMODEL
- Status last verified
- Jan 2017
- First submitted
- 1 Feb 2012
- Last updated
- 24 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Cutler J, Bikhazi N, Light J, Truitt T, Schwartz M; REMODEL Study Investigators. Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: a prospective, multicenter, randomized, controlled trial. Am J Rhinol Allergy. 2013 Sep-Oct;27(5):416-22. doi: 10.2500/ajra.2013.27.3970. Epub 2013 Aug 5.
PubMed 23920419Bikhazi N, Light J, Truitt T, Schwartz M, Cutler J; REMODEL Study Investigators. Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: a prospective, multicenter, randomized, controlled trial with 1-year follow-up. Am J Rhinol Allergy. 2014 Jul-Aug;28(4):323-9. doi: 10.2500/ajra.2014.28.4064. Epub 2014 May 12.
PubMed 24823902Chandra RK, Kern RC, Cutler JL, Welch KC, Russell PT. REMODEL larger cohort with long-term outcomes and meta-analysis of standalone balloon dilation studies. Laryngoscope. 2016 Jan;126(1):44-50. doi: 10.1002/lary.25507. Epub 2015 Jul 30.
PubMed 26228589
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Evaluation of Maxillary Antrostomy Versus Ostial Dilation Efficacy Through Long-Term Follow-Up
- ClinicalTrials.gov ID
- NCT01525849
- Acronym / sponsor ID
- REMODEL / 1984-001
- Conditions
- Chronic Sinusitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Entellus Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 3 Feb 2012 (estimated)
- Results
- Posted 24 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to show that long-term symptom improvement after sinus balloon dilation is not worse than symptom improvement after functional endoscopic sinus surgery (FESS) and that fewer postoperative debridements are required after balloon dilation than after FESS.
Detailed description
This is a postmarket, multicenter, prospective, randomized clinical trial conducted at up to 15 US clinical sites comparing the efficacy of balloon sinus dilation with traditional endoscopic sinus surgery. The primary hypotheses were to demonstrate that: 1) long-term change in sinus symptoms after balloon dilation is not worse (non-inferior) than after FESS, and 2) balloon dilation is superior to FESS for a reduction in the number of postoperative debridements per patient. A minimum of 36 participants per arm is required to test the primary hypotheses. All participants will be followed through a minimum of 12 months post treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balloon Sinus Dilation | Active comparator | Device: Balloon Sinus DilationXprESS Multi-Sinus Dilation Balloon, FinESS Sinus Treatment |
| Functional Endoscopic Sinus Surgery | Active comparator | Procedure: Functional Endoscopic Sinus SurgeryTraditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- maxillary sinus disease
- chronic sinusitis
Key exclusion criteria (4 listed)
- fungal disease
- Samter's triad
- hemophilia
- prior sinus surgery
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 |
|---|---|---|
| Balloon Sinus DilationBalloon sinus dilation using the XprESS Multi-Sinus Dilation Tool or the FinESS SInus Treatment | Device | Balloon Sinus Dilation |
| Functional Endoscopic Sinus SurgeryEndoscopic sinus surgery, specifically, maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy | Procedure or surgery | Functional Endoscopic Sinus Surgery |
Primary outcome
Sinus Symptom Improvement
Time frame: Baseline and 1-year
Change from baseline in overall 20-item Sino-Nasal Outcome Test (SNOT-20) score. The SNOT-20 is a validated patient reported survey of 20 items related to sinonasal symptoms and severity assessed over the previous 2 weeks. Each item is scored from 0 (no problem) to 5 (problem as bad as it can be). The individual item scores are averaged to provide and overall score that ranges from 0 (best) to 5 (worst).
Debridements
Time frame: 1-year
Number of postoperative debridements per participant
3 secondary outcomes
Revision Rate
Time frame: 1-year
Complication Rate
Time frame: Duration of study (minimum of 12 months)
Recovery Time
Time frame: 6-months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23920419Cutler J, Bikhazi N, Light J, Truitt T, Schwartz M; REMODEL Study Investigators. Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: a prospective, multicenter, randomized, controlled trial. Am J Rhinol Allergy. 2013 Sep-Oct;27(5):416-22. doi: 10.2500/ajra.2013.27.3970. Epub 2013 Aug 5.
- Results publication: PubMed 24823902Bikhazi N, Light J, Truitt T, Schwartz M, Cutler J; REMODEL Study Investigators. Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: a prospective, multicenter, randomized, controlled trial with 1-year follow-up. Am J Rhinol Allergy. 2014 Jul-Aug;28(4):323-9. doi: 10.2500/ajra.2014.28.4064. Epub 2014 May 12.
- Results publication: PubMed 26228589Chandra RK, Kern RC, Cutler JL, Welch KC, Russell PT. REMODEL larger cohort with long-term outcomes and meta-analysis of standalone balloon dilation studies. Laryngoscope. 2016 Jan;126(1):44-50. doi: 10.1002/lary.25507. Epub 2015 Jul 30.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balloon Sinus Dilation and Functional Endoscopic Sinus Surgery in people with Chronic Sinusitis, run by Entellus Medical, Inc. 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 3 inclusion and 4 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 24 Feb 2017. 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 24 Feb 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?
Sinus Symptom Improvement (time frame: Baseline and 1-year). 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?
On the ClinicalTrials.gov record for NCT01525849, which also lists 3 linked publications.
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 24 Feb 2017.