NCT01525862

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2011

Geographic Reach
1 country

2 active sites

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

December 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
7.8 years until next milestone

Results Posted

Study results publicly available

October 22, 2020

Completed
Last Updated

November 10, 2020

Status Verified

October 1, 2020

Enrollment Period

1.1 years

First QC Date

February 1, 2012

Results QC Date

September 29, 2020

Last Update Submit

October 21, 2020

Conditions

Chronic SinusitisChronic Rhinosinusitis (Diagnosis)

Keywords

Balloon sinus dilationBalloon cathetersSinuplasty

Outcome Measures

Primary Outcomes (1)

  • 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 6 months post procedure

Secondary Outcomes (3)

  • Recovery Time

    1 week post procedure

  • Procedural Pain Scores

    Immediately post procedure

  • Revision Rate

    6 Months post procedure

Study Arms (1)

Balloon sinus dilation

EXPERIMENTAL

Balloon dilation of the maxillary sinus using a transnasal approach.

Device: Balloon sinus dilation

Interventions

Balloon sinus dilationDEVICE
Also known as: XprESS Multi-Sinus Balloon Dilation Tool
Balloon sinus dilation

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Entellus Medical

Plymouth, Minnesota, 55447, United States

Location

Synergy ENT Specialists

St Louis, Missouri, 63131, United States

Location

Related Links

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Principal Clinical Research & Publications Manager
Organization
Stryker ENT
ellen.omalley@stryker.com
764-463-1598

Study Officials

  • James D. Gould, MD

    Synergy ENT Specialists

    PRINCIPAL INVESTIGATOR

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

February 1, 2012

First Posted

February 3, 2012

Study Start

December 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

November 10, 2020

Results First Posted

October 22, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

US(2)