NCT01525849

Brief Summary

The objective of this study is to show that long-term symptom improvement after sinus balloon dilation is not worse than symptom improvement after functional endoscopic sinus surgery (FESS) and that fewer postoperative debridements are required after balloon dilation than after FESS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
151

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2011

Typical duration for not_applicable

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

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
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

February 24, 2017

Completed
Last Updated

February 24, 2017

Status Verified

January 1, 2017

Enrollment Period

2.2 years

First QC Date

February 1, 2012

Results QC Date

November 1, 2016

Last Update Submit

January 4, 2017

Conditions

Chronic Sinusitis

Outcome Measures

Primary Outcomes (2)

  • Sinus Symptom Improvement

    Change from baseline in overall 20-item Sino-Nasal Outcome Test (SNOT-20) score. The SNOT-20 is a validated patient reported survey of 20 items related to sinonasal symptoms and severity assessed over the previous 2 weeks. Each item is scored from 0 (no problem) to 5 (problem as bad as it can be). The individual item scores are averaged to provide and overall score that ranges from 0 (best) to 5 (worst).

    Baseline and 1-year

  • Debridements

    Number of postoperative debridements per participant

    1-year

Secondary Outcomes (3)

  • Revision Rate

    1-year

  • Complication Rate

    Duration of study (minimum of 12 months)

  • Recovery Time

    6-months

Study Arms (2)

Balloon Sinus Dilation

ACTIVE COMPARATOR

XprESS Multi-Sinus Dilation Balloon, FinESS Sinus Treatment

Device: Balloon Sinus Dilation

Functional Endoscopic Sinus Surgery

ACTIVE COMPARATOR

Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.

Procedure: Functional Endoscopic Sinus Surgery

Interventions

Balloon Sinus DilationDEVICE

Balloon sinus dilation using the XprESS Multi-Sinus Dilation Tool or the FinESS SInus Treatment

Balloon Sinus Dilation
Functional Endoscopic Sinus SurgeryPROCEDURE

Endoscopic sinus surgery, specifically, maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy

Functional Endoscopic Sinus Surgery

Eligibility Criteria

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

You may qualify if:

  • years or older
  • maxillary sinus disease
  • chronic sinusitis

You may not qualify if:

  • fungal disease
  • Samter's triad
  • hemophilia
  • prior sinus surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Entellus Medical

Plymouth, Minnesota, 55447, United States

Location

Related Publications (3)

  • Cutler J, Bikhazi N, Light J, Truitt T, Schwartz M; REMODEL Study Investigators. Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: a prospective, multicenter, randomized, controlled trial. Am J Rhinol Allergy. 2013 Sep-Oct;27(5):416-22. doi: 10.2500/ajra.2013.27.3970. Epub 2013 Aug 5.

    PMID: 23920419RESULT

  • Bikhazi N, Light J, Truitt T, Schwartz M, Cutler J; REMODEL Study Investigators. Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: a prospective, multicenter, randomized, controlled trial with 1-year follow-up. Am J Rhinol Allergy. 2014 Jul-Aug;28(4):323-9. doi: 10.2500/ajra.2014.28.4064. Epub 2014 May 12.

    PMID: 24823902RESULT

  • Chandra RK, Kern RC, Cutler JL, Welch KC, Russell PT. REMODEL larger cohort with long-term outcomes and meta-analysis of standalone balloon dilation studies. Laryngoscope. 2016 Jan;126(1):44-50. doi: 10.1002/lary.25507. Epub 2015 Jul 30.

    PMID: 26228589RESULT

Results Point of Contact

Title
Ellen O'Malley
Organization
Entellus Medical
eomalley@entellusmedical.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
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
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

February 1, 2014

Study Completion

May 1, 2014

Last Updated

February 24, 2017

Results First Posted

February 24, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)