NCT01612780

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 6, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
7.1 years until next milestone

Results Posted

Study results publicly available

October 22, 2020

Completed
Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

1.5 years

First QC Date

June 1, 2012

Results QC Date

September 29, 2020

Last Update Submit

October 21, 2020

Conditions

Sinusitis

Keywords

SinusitisSinus balloon dilation patients

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and 1-year post procedure

Secondary Outcomes (2)

  • Revision Sinus Surgery

    1-year post procedure

  • Number of Participants With Serious Device and/or Procedure-related Adverse Events

    Through 1-year post procedure follow-up

Study Arms (1)

XprESS Multi-Sinus Dilation Tool

EXPERIMENTAL

Balloon sinus dilation

Device: XprESS Multi-Sinus Dilation Tool

Interventions

XprESS Multi-Sinus Dilation ToolDEVICE

Sinus balloon dilation

Also known as: Sinus balloon dilation
XprESS Multi-Sinus Dilation Tool

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Entellus Medical

Plymouth, Minnesota, 55447, United States

Location

Related Publications (1)

  • 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.

    PMID: 24598043RESULT

Related Links

MeSH Terms

Conditions

Sinusitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Results Point of Contact

Title
Principal Clinical Research & Publications Manager
Organization
Stryker ENT
ellen.omalley@stryker.com
763-463-1598

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2012

First Posted

June 6, 2012

Study Start

April 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

October 22, 2020

Results First Posted

October 22, 2020

Record last verified: 2020-10

Locations

US(1)