Clinical trial NCT00986830: Healthcare Utilization and Outcomes of FinESS Treatment in the Office
Official title: Healthcare Utilization and Outcomes of FinESS Treatment in the Office
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rhinosinusitis
Keywords: Rhinosinusitis
Balloon catheters
Office treatment
Otorhinolaryngologic diseases
Respiratory tract infections
Respiratory tract diseases
FinESS Sinus Treatment
Endoscopic sinus surgery
Lead sponsor: Entellus Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2009-09-30
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A prospective, nonrandomized trial to evaluate postoperative healthcare resource utilization after maxillary balloon antrostomy using FinESS Sinus Treatment in the physician's office.

Detailed description: A prospective, nonrandomized trial to evaluate postoperative healthcare resource utilization after maxillary balloon antrostomy using FinESS Sinus Treatment in the physician's office. Also to demonstrate the long-term durability of FinESS Sinus Treatment performed in an office setting.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Male or female subjects
* Diagnosis of rhinosinusitis (CT radiographic evidence and medical evaluation)
* Willing to comply with protocol requirements
* Able to provide consent

Exclusion Criteria:

* Hemophilia
* Cystic fibrosis
* Ciliary dysfunction
* Severe septal deviation causing obstruction of the ostiomeatal unit
* Pregnant females

Primary outcomes:
measure: Sino-Nasal Outcomes Test
timeFrame: Baseline and 12 months post procedure
Secondary outcomes:
measure: Rhinosinusitis Symptom Inventory (RSI) Nasal Symptoms Domain
timeFrame: Baseline and 12 months post procedure
measure: Rhinosinusitis Symptom Inventory (RSI) Facial Symptoms Domain
timeFrame: Baseline and 12 months post procedure
measure: Rhinosinusitis Symptom Inventory (RSI) Oropharyngeal Symptoms Domain
timeFrame: Baseline and 12 months post procedure
measure: Rhinosinusitis Symptom Inventory (RSI) Systemic Symptoms Domain
timeFrame: Baseline and 12 months post procedure
measure: Number of Participants Using Nasal Steroids
timeFrame: Baseline and 12 months post procedure
measure: Number of Participants Using Antihistamines
timeFrame: Baseline and 12 months post procedure
measure: Number of Participants Using Antibiotics
timeFrame: Baseline and 12 months post procedure
measure: Number of Participants With Device and/or Procedure-related Adverse Events
timeFrame: Baseline through 12 months post procedure
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Central California ENT
state: California
city: Denver
country: United States
facility: South Denver ENT and Allergy
state: Colorado
city: Trumbull
country: United States
facility: ENT and Allergy Associates
state: Connecticut
city: Evanston
country: United States
facility: NorthShore University
state: Illinois
city: Louisville
country: United States
facility: Advanced ENT and Allergy
state: Kentucky
city: Saint Cloud
country: United States
facility: St. Cloud Ear, Nose and Throat
state: Minnesota
city: New Bern
country: United States
facility: Coastal Ear, Nose and Throat Associates
state: North Carolina
city: Sioux Falls
country: United States
facility: Midwest Ear, Nose and Throat
state: South Dakota
city: Kingsport
country: United States
facility: Holston Medical Center
state: Tennessee
city: Austin
country: United States
facility: Austin Ear, Nose and Throat
state: Texas
city: Boerne
country: United States
facility: Texas Sinus Center
state: Texas
city: Dallas
country: United States
facility: The Snoring Center
state: Texas
city: Richmond
country: United States
facility: Advanced Otolaryngology PC
state: Virginia
Study officials:
References:
citation: Levine SB, Truitt T, Schwartz M, Atkins J. In-office stand-alone balloon dilation of maxillary sinus ostia and ethmoid infundibula in adults with chronic or recurrent acute rhinosinusitis: a prospective, multi-institutional study with-1-year follow-up. Ann Otol Rhinol Laryngol. 2013 Nov;122(11):665-71. doi: 10.1177/000348941312201101.