SinusitisNCT02278484

Sinus Balloon Dilation in Pediatric Patients

A study testing XprESS device and PathAssist confirmation tools in people with Sinusitis, run by Entellus Medical, Inc. at 4 sites in United States.

Completed

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

Official record

Search all trials

Trial summary

Safety and effectiveness of sinus balloon dilation in patients 2-21 years old. Read more about this study

Who is it for?: Ages 2 to 21 years
Conditions the study is for: Sinusitis
What is being tested?: XprESS device and PathAssist confirmation tools
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 4 sitesUnited States
Study dates: Sep 2014to Jan 2016
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 2 to 21 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Patients age ≥ 2 to ≤ 21 years old. Diagnosed with Chronic Rhinosinusitis (CRS). Candidate for trans-nasal balloon sinus dilation.

Who cannot join

History of sinus surgery. Recent nasal or head and neck surgery. Fungal sinus disease. Severe asthma. Cystic fibrosis. Immunodeficiency. Craniofacial abnormalities. Pregnancy (current)

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Medical University of South Carolina
Charleston, South Carolina, 29425
North Valley ENT
Phoenix, Arizona, 85032
Willamette ENT and Facial Plastic Surgery
Salem, Oregon, 97302
Alamo ENT and Associates
San Antonio, Texas, 78258

Other trials in United States

About this study

Official title: XprESS Device and PathAssist Confirmation Tools in Pediatric Patients-Expanded Indication Study

Safety and effectiveness of sinus balloon dilation in patients 2-21 years old.

Conditions: Sinusitis
Being tested: XprESS device and PathAssist confirmation tools
Keywords: sinus infections, sinusitis, chronic sinusitis, rhinosinusitis, allergic sinusitis, allergic rhinitis, chronic rhinosinusitis, sinus disease in children, sinus balloon dilation, balloon dilatation, sinus disease, pediatric
Medical subject headings: Sinusitis, Rhinosinusitis, Rhinitis, Allergic, Paranasal Sinus Diseases

What participants receive

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

XprESS device and PathAssist confirmation toolsDevice

Study groups in NCT02278484
Study group	Role	What they receive
Balloon Sinus Dilation	Other	Not described Receives: Device: XprESS device and PathAssist confirmation tools

What is being measured

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

Technical Success: Sinuses Successfully Treated With Balloon Dilation
Number of successful dilations out of all attempted dilations. Success is defined as the device successfully delivered to the target sinus, inflated, deflated, and withdrawn from the treated sinus.
Measured: Index procedure
Complications
Number of subjects who experience complications. Complications are defined as serious device or procedure related adverse events.
Measured: Index procedure through 3-month follow-up

Secondary outcomes (2)

Change in Quality of Life From Baseline Through Completion
Change in sinonasal symptom severity between the baseline preprocedure assessment and follow-up assessment. Sinus symptom severity is measured using the Sinus and Nasal Quality of Life Survey (SN-5) that is a validated tool for use in pediatric patients (completed by caregivers). The 5 survey items are scored from 1 (best) to 7 (worst) and averaged to provide an overall score.
Measured: Baseline to 6-month follow-up
Number of Subjects Who Undergo a Revision or Additional Surgery During the Study
Any surgical intervention that is performed in the sinus(es) following the index procedure will be reported
Measured: Procedure-6 month follow up

Timeline

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

Sep 2014Jan 2016

First posted30 Oct 2014 (estimated)
Study startSep 2014
Primary completionSep 2015
Study completionJan 2016

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: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02278484
Sponsor's protocol ID: 2827-001
Status last verified: Feb 2017
First submitted: 27 Oct 2014
Last updated: 11 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Soler ZM, Rosenbloom JS, Skarada D, Gutman M, Hoy MJ, Nguyen SA. Prospective, multicenter evaluation of balloon sinus dilation for treatment of pediatric chronic rhinosinusitis. Int Forum Allergy Rhinol. 2017 Mar;7(3):221-229. doi: 10.1002/alr.21889. Epub 2016 Nov 26.
PubMed 27888649

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

Not yet recruiting
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)
Respiratory Tract Infection, Smell Disorder
Not yet recruiting
Peppermint and Decongestant Technique on Chronic Sinusitis
Sinus Disease

All Sinusitis trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: XprESS Device and PathAssist Confirmation Tools in Pediatric Patients-Expanded Indication Study
ClinicalTrials.gov ID: NCT02278484
Acronym / sponsor ID: 2827-001
Conditions: Sinusitis
Keywords: sinus infections, sinusitis, chronic sinusitis, rhinosinusitis, allergic sinusitis, allergic rhinitis, chronic rhinosinusitis, sinus disease in children
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Entellus Medical, Inc.Industry (pharma, biotech, devices)
Study start: Sep 2014
Primary completion: Sep 2015 (actual)
Study completion: Jan 2016 (actual)
First posted: 30 Oct 2014 (estimated)
Results: Posted 7 Dec 2016

Clinical summary

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

Safety and effectiveness of sinus balloon dilation in patients 2-21 years old.

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	Other	Device: XprESS device and PathAssist confirmation tools

Who may qualify

Ages: 2 to 21 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (1 listed)

Patients age ≥ 2 to ≤ 21 years old. Diagnosed with Chronic Rhinosinusitis (CRS). Candidate for trans-nasal balloon sinus dilation.

Key exclusion criteria (1 listed)

History of sinus surgery. Recent nasal or head and neck surgery. Fungal sinus disease. Severe asthma. Cystic fibrosis. Immunodeficiency. Craniofacial abnormalities. Pregnancy (current)

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 device and PathAssist confirmation tools	Device	Balloon Sinus Dilation

Primary outcome

Technical Success: Sinuses Successfully Treated With Balloon Dilation
Time frame: Index procedure
Number of successful dilations out of all attempted dilations. Success is defined as the device successfully delivered to the target sinus, inflated, deflated, and withdrawn from the treated sinus.
Complications
Time frame: Index procedure through 3-month follow-up
Number of subjects who experience complications. Complications are defined as serious device or procedure related adverse events.

2 secondary outcomes

Change in Quality of Life From Baseline Through Completion
Time frame: Baseline to 6-month follow-up
Number of Subjects Who Undergo a Revision or Additional Surgery During the Study
Time frame: Procedure-6 month follow up

Results and safety

Results posted to the registry on 7 Dec 2016, 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	50	50

Primary outcome: Technical Success: Sinuses Successfully Treated With Balloon Dilation

Time frame: Index procedure. Number. Unit: sinus dilation attempts

Measure	Balloon Sinus Dilation n = 50
Value	157

Population analysed: All sinus dilations attempted in all participants

Primary outcome: Complications

Time frame: Index procedure through 3-month follow-up. Number. Unit: participants

Measure	Balloon Sinus Dilation n = 50
Value	0

Population analysed: All participants

2 secondary outcomes are reported in the full results.

Adverse events

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

Group	Serious adverse events	Other adverse events	Deaths
Balloon Sinus Dilation	0 of 50 (0%)	0 of 50 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27888649Soler ZM, Rosenbloom JS, Skarada D, Gutman M, Hoy MJ, Nguyen SA. Prospective, multicenter evaluation of balloon sinus dilation for treatment of pediatric chronic rhinosinusitis. Int Forum Allergy Rhinol. 2017 Mar;7(3):221-229. doi: 10.1002/alr.21889. Epub 2016 Nov 26.
Individual participant dataSharing planned: No

Related trials for Sinusitis

Not yet recruiting
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)
Respiratory Tract Infection, Smell Disorder
Not yet recruiting
Peppermint and Decongestant Technique on Chronic Sinusitis
Sinus Disease

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.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing XprESS device and PathAssist confirmation tools in people with Sinusitis, run by Entellus Medical, Inc. at 4 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 1 inclusion and 1 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 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 7 Dec 2016). 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?

Technical Success: Sinuses Successfully Treated With Balloon Dilation (time frame: Index procedure). 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 NCT02278484, 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 11 Apr 2017.