SinusitisNCT01612780

Trans-Nasal Maxillary Multi-Sinus Balloon Dilation Study

A study testing XprESS Multi-Sinus Dilation Tool in people with Sinusitis, run by Entellus Medical, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to show clinically meaningful improvement in symptom severity after transnasal balloon dilation of the maxillary sinus outflow tract with or without balloon dilation of the frontal or sphenoid sinuses. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Sinusitis
What is being tested?: XprESS Multi-Sinus Dilation Tool
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 82 participants
Where: 1 siteUnited States
Study dates: Apr 2012to Oct 2013
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

Be at least age 18 years old or older.
Be a candidate for transnasal balloon dilation of the maxillary sinus(es) with or without balloon dilation of the frontal or sphenoid sinus(es) using XprESS consistent with the device's Indication for Use.
Have a sinus CT scan within 12 months of the procedure date.
Be able and willing to provide consent.
Be willing to comply with the protocol requirements.

Who cannot join

Have any prior maxillary sinus surgery (eg, antrostomy, uncinectomy).
Require any concomitant endoscopic sinus surgery (ESS) or nasal surgery (exception: turbinate reduction) at the time of the study procedure.
Have any nasal surgery (eg, septoplasty) or nonmaxillary sinus surgery (eg, frontal sinusotomy, sphenoidotomy, full/partial ethmoidectomy) performed within 3 months prior to enrollment.
Have presence of features consistent with sinus fungal disease.
Be allergic to nickel or barium sulfate.
Be currently participating in any other drug or device clinical studies excluding postapproval or marketing registry studies.

Trial locations and contacts

1 site in 1 country.

United States1 site

Entellus Medical
Plymouth, Minnesota, 55447

Other trials in United States

About this study

Read the detailed description

This is a prospective, non-randomized, single arm, post-approval study conducted under a common protocol designed to evaluate outcomes following trans-nasal balloon dilation of the maxillary sinus outflow tract with or without concurrent balloon dilation of the frontal or sphenoid sinuses and without any concomitant conventional sinus surgery (ie, uncinectomy, complete or partial ethmoidectomy).

Conditions: Sinusitis
Being tested: XprESS Multi-Sinus Dilation Tool
Keywords: Sinusitis, Sinus balloon dilation patients
Medical subject headings: Sinusitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

XprESS Multi-Sinus Dilation ToolDevice
Also called Sinus balloon dilation
Sinus balloon dilation

Study groups in NCT01612780
Study group	Role	What they receive
XprESS Multi-Sinus Dilation Tool	Experimental	Balloon sinus dilation Receives: Device: XprESS Multi-Sinus Dilation Tool

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in SNOT-20 Score
The 20-item Sino-Nasal Outcomes Test (SNOT-20) is a validated patient-reported outcome measure for assessing the presence and severity of symptoms of chronic rhinosinusitis. Symptoms on the SNOT-20 survey are each rated on a scale from 0 (no problem) to 5 (problem as bad as it can be) and the 20 symptom scores are averaged to provide a total score ranging from 0 to 5. The minimal clinically important difference in the SNOT-20 has been determined to be a reduction greater or equal to 0.8 in the total SNOT-20 score.
Measured: Baseline and 1-year post procedure

Secondary outcomes (2)

Revision Sinus Surgery
The number of participants who require revision sinus surgery to address continuing sinus symptoms.
Measured: 1-year post procedure
Number of Participants With Serious Device and/or Procedure-related Adverse Events
Serious adverse events that are considered to be possibly, probably, or definitely related to the balloon device and/or dilation procedure.
Measured: Through 1-year post procedure follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2012Oct 2013

First posted6 Jun 2012 (estimated)
Study startApr 2012
Primary completionOct 2013
Study completionOct 2013

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 (1)Papers the sponsor has linked to this study.
Other trials for 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 82 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01612780
Sponsor's protocol ID: 2233-001
Status last verified: Oct 2020
First submitted: 1 Jun 2012
Last updated: 22 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Gould J, Alexander I, Tomkin E, Brodner D. In-office, multisinus balloon dilation: 1-Year outcomes from a prospective, multicenter, open label trial. Am J Rhinol Allergy. 2014 Mar-Apr;28(2):156-63. doi: 10.2500/ajra.2014.28.4043. Epub 2014 Feb 14.
PubMed 24598043

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Sinusitis trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Trans-Nasal Maxillary Multi-Sinus Balloon Dilation Study
ClinicalTrials.gov ID: NCT01612780
Acronym / sponsor ID: 2233-001
Conditions: Sinusitis
Keywords: Sinusitis, Sinus balloon dilation patients
Study type: Interventional
Recruitment status: Completed
Enrolment: 82 participants (actual)
Lead sponsor: Entellus Medical, Inc.Industry (pharma, biotech, devices)
Study start: Apr 2012
Primary completion: Oct 2013 (actual)
Study completion: Oct 2013 (actual)
First posted: 6 Jun 2012 (estimated)
Results: Posted 22 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
XprESS Multi-Sinus Dilation Tool	Experimental	Device: XprESS Multi-Sinus Dilation ToolBalloon sinus dilation

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Be at least age 18 years old or older.
Be a candidate for transnasal balloon dilation of the maxillary sinus(es) with or without balloon dilation of the frontal or sphenoid sinus(es) using XprESS consistent with the device's Indication for Use.
Have a sinus CT scan within 12 months of the procedure date.
Be able and willing to provide consent.
Be willing to comply with the protocol requirements.

Key exclusion criteria (6 listed)

Have any prior maxillary sinus surgery (eg, antrostomy, uncinectomy).
Require any concomitant endoscopic sinus surgery (ESS) or nasal surgery (exception: turbinate reduction) at the time of the study procedure.
Have any nasal surgery (eg, septoplasty) or nonmaxillary sinus surgery (eg, frontal sinusotomy, sphenoidotomy, full/partial ethmoidectomy) performed within 3 months prior to enrollment.
Have presence of features consistent with sinus fungal disease.
Be allergic to nickel or barium sulfate.

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
XprESS Multi-Sinus Dilation ToolAlso: Sinus balloon dilationSinus balloon dilation	Device	XprESS Multi-Sinus Dilation Tool

Primary outcome

Change in SNOT-20 Score
Time frame: Baseline and 1-year post procedure
The 20-item Sino-Nasal Outcomes Test (SNOT-20) is a validated patient-reported outcome measure for assessing the presence and severity of symptoms of chronic rhinosinusitis. Symptoms on the SNOT-20 survey are each rated on a scale from 0 (no problem) to 5 (problem as bad as it can be) and the 20 symptom scores are averaged to provide a total score ranging from 0 to 5. The minimal clinically important difference in the SNOT-20 has been determined to be a reduction greater or equal to 0.8 in the total SNOT-20 score.

2 secondary outcomes

Revision Sinus Surgery
Time frame: 1-year post procedure
Number of Participants With Serious Device and/or Procedure-related Adverse Events
Time frame: Through 1-year post procedure follow-up

Results and safety

Results posted to the registry on 22 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Balloon Sinus Dilation	82	76

Primary outcome: Change in SNOT-20 Score

Time frame: Baseline and 1-year post procedure. Mean (Standard Deviation). Unit: score on a scale

Measure	Balloon Sinus Dilation n = 75
Baseline	2.3 (0.92)
1-Year follow-up	0.7 (0.75)

Balloon Sinus Dilation: p <0.0001, t-test, 2 sided

Population analysed: All participants who had 1 or more sinuses successfully treated with the XprESS device and both baseline and 1-year follow-up SNOT-20 scores available for analysis.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were systematically collected by standardized case report forms through 1 year post procedure.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Balloon Sinus Dilation	1 of 82 (1.2%)	0 of 82 (0%)	0 of 82

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 24598043Gould J, Alexander I, Tomkin E, Brodner D. In-office, multisinus balloon dilation: 1-Year outcomes from a prospective, multicenter, open label trial. Am J Rhinol Allergy. 2014 Mar-Apr;28(2):156-63. doi: 10.2500/ajra.2014.28.4043. Epub 2014 Feb 14.
Entellus Medical patient-facing website about sinusitisLink provided by the sponsor.

Related trials for Sinusitis

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FESS With or Without Intranasal Desmopressin in Chronic Rhinosinusitis With Nasal Polyps
Chronic Sinusitis, Nasal Polyposis
RecruitingPhase 4
Comparative Effectiveness of Available Treatments for Sinus and Ear Infections in Children (Acute Sinusitis)
ACUTE SINUSITIS, Sinusitis
Not yet recruitingObservational study
Post-market Clinical Follow-up Study of an Isotonic Saline Solution for the Relief of Nasal Congestion in Infants and Toddlers
Nasal Congestion, Common Cold
RecruitingObservational study
Longitudinal Deep Phenotyping of Central Mechanisms in Dysosmia: A Pilot Study Using Electrobulbogram (EBG), Functional MRI (fMRI), and Diffusion-Weighted Imaging (DWI)
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Not yet recruiting
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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 XprESS Multi-Sinus Dilation Tool in people with 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 5 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 22 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 22 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?

Change in SNOT-20 Score (time frame: Baseline and 1-year post procedure). 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 NCT01612780, which also lists 1 linked publication.

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 22 Oct 2020.