Chronic SinusitisNCT01525862

XprESS Maxillary Balloon Dilation Study

A study testing Balloon sinus dilation in people with Chronic Sinusitis and Chronic Rhinosinusitis (Diagnosis), run by Entellus Medical, Inc. at 2 sites 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

A prospective, single-arm, post approval pilot study. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Sinusitis, Chronic Rhinosinusitis (Diagnosis)
What is being tested?: Balloon sinus dilation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 2 sitesUnited States
Study dates: Dec 2011to Jan 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 18 years of age.
Must have uncomplicated sinusitis of the maxillary sinuses with or without anterior ethmoid disease.
Meet EITHER the Anthem Coverage Guideline OR BlueCross BlueShield of North Carolina Corporate Medical Policy for medically necessary functional endoscopic sinus surgery (FESS) to treat uncomplicated sinusitis.
Have a CT scan within 6 months prior to enrollment.
Be mentally and physically capable (as per physician discretion) to participate in the investigation.
Be willing and able to sign the study-specific informed consent prior to any study-related procedures.
Be willing and able to undergo balloon dilation in the clinic setting.

Who cannot join

Have evidence of posterior ethmoid, sphenoid or frontal sinus (excludes presence of mucous retention cysts) disease requiring endoscopic sinus surgery or balloon dilatation.
Have presence of features consistent with sinus fungal disease.
Have evidence of gross polypoid disease within any of the sinuses or within the infundibulum.
Require concurrent nasal surgery (eg, septoplasty, turbinate reduction, etc).
Have previous sinus surgery (eg, sinus surgery or balloon sinuplasty).
Have nasal surgery (eg, septoplasty, turbinate reduction) performed within 3 months prior to enrollment.

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Have any anatomical anomaly (ie, severe septal deviation) preventing transnasal access to the maxillary sinus outflow tract.
Have a history of primary ciliary dysfunction.
Have hemophilia.
Be currently undergoing, or have undergone in the past 6 months, chemotherapy for cancer or radiation therapy in the head or neck region.
Have a history of cystic fibrosis.
Have Sampter's Triad (ie, defined as having all 3 of the following: aspirin sensitivity, asthma, and sinonasal polyposis).
Have known sinonasal tumors or obstructive lesions.
Be pregnant at the time of enrollment.
Be unable to stop anticoagulant medication (eg, warfarin) until the International Normalized Ratio (INR) is below 1.5.
Be unable to stop antiplatelet (eg, clopidogrel, aspirin, etc.) for at least 7 days prior to study procedure.
Be currently participating in any other drug or device clinical studies excluding postapproval or marketing registry studies.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Entellus Medical
Plymouth, Minnesota, 55447
Synergy ENT Specialists
St Louis, Missouri, 63131

Other trials in United States

About this study

Official title: XprESS Maxillary Sinus Balloon Dilation Study

A prospective, single-arm, post approval pilot study.

Read the detailed description

This study is evaluating transnasal sinus balloon dilation without tissue removal to treat the maxillary sinuses in patients with sinusitis. The study will be assessing symptomatic improvement post procedure.

Conditions: Chronic Sinusitis, Chronic Rhinosinusitis (Diagnosis)
Being tested: Balloon sinus dilation
Keywords: Balloon sinus dilation, Balloon catheters, Sinuplasty
Medical subject headings: Disease

What participants receive

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

Balloon sinus dilationDevice
Also called XprESS Multi-Sinus Balloon Dilation Tool

Study groups in NCT01525862
Study group	Role	What they receive
Balloon sinus dilation	Experimental	Balloon dilation of the maxillary sinus using a transnasal approach. Receives: Device: Balloon sinus dilation

What is being measured

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

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 6 months post procedure

Secondary outcomes (3)

Recovery Time
Patient-reported time from procedure to ability to return to normal daily activities.
Measured: 1 week post procedure
Procedural Pain Scores
Procedure pain/discomfort on a scale of 0 (no pain) to 10 (severe pain) as reported by the participant.
Measured: Immediately post procedure
Revision Rate
The number of participants who require revision sinus surgery during the study duration.
Measured: 6 Months post procedure

Timeline

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

Dec 2011Jan 2013

First posted3 Feb 2012 (estimated)
Study startDec 2011
Primary completionJan 2013
Study completionJan 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.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01525862
Sponsor's protocol ID: 2091-001
Status last verified: Oct 2020
First submitted: 1 Feb 2012
Last updated: 10 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

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 Chronic Sinusitis trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: XprESS Maxillary Sinus Balloon Dilation Study
ClinicalTrials.gov ID: NCT01525862
Acronym / sponsor ID: 2091-001
Conditions: Chronic Sinusitis, Chronic Rhinosinusitis (Diagnosis)
Keywords: Balloon sinus dilation, Balloon catheters, Sinuplasty
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Entellus Medical, Inc.Industry (pharma, biotech, devices)
Study start: Dec 2011
Primary completion: Jan 2013 (actual)
Study completion: Jan 2013 (actual)
First posted: 3 Feb 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.

A prospective, single-arm, post approval pilot study.

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
Balloon sinus dilation	Experimental	Device: Balloon sinus dilationBalloon dilation of the maxillary sinus using a transnasal approach.

Who may qualify

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

Key inclusion criteria (7 listed)

Be at least 18 years of age.
Must have uncomplicated sinusitis of the maxillary sinuses with or without anterior ethmoid disease.
Meet EITHER the Anthem Coverage Guideline OR BlueCross BlueShield of North Carolina Corporate Medical Policy for medically necessary functional endoscopic sinus surgery (FESS) to treat uncomplicated sinusitis.
Have a CT scan within 6 months prior to enrollment.
Be mentally and physically capable (as per physician discretion) to participate in the investigation.

Key exclusion criteria (17 listed)

Have evidence of posterior ethmoid, sphenoid or frontal sinus (excludes presence of mucous retention cysts) disease requiring endoscopic sinus surgery or balloon dilatation.
Have presence of features consistent with sinus fungal disease.
Have evidence of gross polypoid disease within any of the sinuses or within the infundibulum.
Require concurrent nasal surgery (eg, septoplasty, turbinate reduction, etc).
Have previous sinus surgery (eg, sinus surgery or balloon sinuplasty).

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 dilationAlso: XprESS Multi-Sinus Balloon Dilation Tool	Device	Balloon sinus dilation

Primary outcome

SNOT-20 Score
Time frame: Baseline and 6 months 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.

3 secondary outcomes

Recovery Time
Time frame: 1 week post procedure
Procedural Pain Scores
Time frame: Immediately post procedure
Revision Rate
Time frame: 6 Months post procedure

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	21	21

Primary outcome: SNOT-20 Score

Time frame: Baseline and 6 months post procedure. Mean (Standard Deviation). Unit: score on a scale

Measure	Balloon Sinus Dilation n = 21
Baseline	2.3 (0.8)
6-Month Follow-up	0.8 (0.6)

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

Population analysed: All participants with baseline and 6-month follow-up SNOT-20 assessments (matched pairs).

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months post procedure. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Balloon Sinus Dilation	1 of 21 (4.8%)	0 of 21 (0%)	0 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Chronic Sinusitis

Not yet recruiting
FESS With or Without Intranasal Desmopressin in Chronic Rhinosinusitis With Nasal Polyps
Chronic Sinusitis, Nasal Polyposis
Not yet recruiting
Peppermint and Decongestant Technique on Chronic Sinusitis
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Not yet recruiting
Effect of Probiotic Nasal Irrigation on the Postoperative Care of Chronic Rhinosinusitis
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Active, not recruitingPhase 3
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
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Active, not recruitingObservational study
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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.

James D. Gould, MD principal investigator

Synergy ENT Specialists

2 sites 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 in people with Chronic Sinusitis and Chronic Rhinosinusitis (Diagnosis), run by Entellus Medical, Inc. 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 7 inclusion and 17 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 10 Nov 2020. 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 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?

SNOT-20 Score (time frame: Baseline and 6 months 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 NCT01525862.

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 10 Nov 2020.