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NCT01525849 Clinical Trial

Randomized Evaluation of Maxillary Antrostomy Versus Ostial Dilation Efficacy Through Long-Term Follow-Up

Chronic Sinusitis Clinical Trial

— REMODEL  

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01525849
Other study ID # 1984-001
Secondary ID
Status Completed
Phase N/A
First received February 1, 2012
Last updated May 22, 2014
Start date December 2011
Est. completion date May 2014

Study information
Verified date May 2014
Source Entellus Medical, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The objective of this study is to show that long-term symptom improvement following sinus balloon dilation is not worse than symptom improvement following functional endoscopic sinus surgery.

Recruitment information / eligibility
Status Completed
Enrollment 151
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 18 years or older

- maxillary sinus disease

- chronic sinusitis

Exclusion Criteria:

- fungal disease

- Samter's triad

- hemophilia

- prior sinus surgery

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Balloon Sinus Dilation
Balloon Sinus Dilation
Procedure:
• Functional Endoscopic Sinus Surgery
Endoscopic sinus surgery

Locations
Country Name City State
United States Entellus Medical Maple Grove Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Entellus Medical, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 Aller — View Citation

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) — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Symptom improvement one year No
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