Clinical trial NCT02087150: Study of Safety and Efficacy for the Eustachian Tube Balloon Catheter
Official title: A Randomized Clinical Study of Safety and Efficacy for the Eustachian Tube Balloon Catheter (ELLIOTT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eustachian Tube Dysfunction
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
Collaborators: name: Acclarent
First posted: 2014-03-14
Enrollment: 323
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to determine whether Eustachian tube dilation in conjunction with medical management or medical management alone is effective for treating Eustachian tube dysfunction.


Eligibility criteria: Inclusion Criteria:

* Adult male or female aged 22 years and older
* Persistent Eustachian tube dysfunction
* Failure of medical management
* Positive diagnosis of ETD
* Absence of internal carotid artery (ICA) dehiscence
* Able to read and understand English

Exclusion Criteria:

* Females who are pregnant or lactating
* Anatomy that requires an adjunctive surgical procedure
* Concomitant nasal or sinus procedures planned on the same day as surgical procedure
* Concomitant ear procedures planned on the same day as surgical procedure
* History of major surgery of the head or neck within four (4) months prior to surgery
* History of patulous ET
* History of fluctuating sensorineural hearing loss
* Active acute otitis media
* Tympanic membrane perforation
* Tympanosclerosis
* Acute upper respiratory infection
* Temporomandibular joint disorder
* Cleft palate
* Craniofacial syndrome
* Cystic fibrosis
* Ciliary dysmotility syndrome
* Systemic mucosal or immunodeficiency disease
* Intolerance of medication for ETD
* Prior intervention of Eustachian tube

Primary outcomes:
measure: Primary Efficacy Analysis: Number of Randomized Subjects With Tympanogram Normalization at 6 Weeks
timeFrame: 6 Week Follow-Up Visit
Secondary outcomes:
measure: Secondary Efficacy Endpoint: Number of Randomized Subjects With MID Improvement From Baseline of 0.5 Points or More at 6 Weeks
timeFrame: 6 Week Follow-Up Visit
Other outcomes:
measure: Exploratory Endpoint: Number of Randomized Subjects With Normalized Tympanometry at 12.24,52 Weeks
timeFrame: 12, 24, 52 Week Follow-Up
measure: Exploratory Endpoint: Number of Randomized Subjects With ETDQ-7 Improvement at 12, 24, 52 Weeks
timeFrame: 12,24,52 Week Follow-Up Visit
measure: Exploratory Endpoint: WPAI at 6,12,24,52 Weeks
timeFrame: 6,12,24,52 Week Follow-Up
Locations:
city: East Palo Alto
country: United States
facility: California Ear Institute
state: California
city: Washington
country: United States
facility: George Washington Medical Faculty Associates, ENT Center
state: District of Columbia
city: Boca Raton
country: United States
facility: ENT of South Florida
state: Florida
city: Boynton Beach
country: United States
facility: ENT of South Florida
state: Florida
city: Sarasota
country: United States
facility: Florida Ear & Sinus Center
state: Florida
city: Atlanta
country: United States
facility: ENT of Georgia
state: Georgia
city: Atlanta
country: United States
facility: Piedmont Ear, Nose & Throat &Related Allergy
state: Georgia
city: Lebanon
country: United States
facility: Witham Health Services
state: Indiana
city: Alexandria
country: United States
facility: Red River Sinus Center
state: Louisiana
city: Baton Rouge
country: United States
facility: Our Lady of the Lake Hospital
state: Louisiana
city: Boston
country: United States
facility: Children's Hospital
state: Massachusetts
city: Saint Paul
country: United States
facility: Health Partners Specialty Center
state: Minnesota
city: Ocean Springs
country: United States
facility: The Sinus Center of the South
state: Mississippi
city: New York
country: United States
facility: Vijay Anand, LLC
state: New York
city: Port Jefferson
country: United States
facility: Ear, Nose, Throat and Allergy Associates, LLP
state: New York
city: White Plains
country: United States
facility: Ear, Nose, Throat and Allergy Associates, LLP
state: New York
city: Charlotte
country: United States
facility: Charlotte Eye, Ear, Nose &Throat Associates
state: North Carolina
city: Raleigh
country: United States
facility: Carolina Ear and Hearing Clinic
state: North Carolina
city: Fort Worth
country: United States
facility: Texas Healthcare, PLLC
state: Texas
city: San Antonio
country: United States
facility: Ear Medical Group
state: Texas
city: Monona
country: United States
facility: Meriter Monona
state: Wisconsin
Study officials:
affiliation: Boston Children's Hospital
name: Dennis Poe, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Memorial Sloan Kettering Cancer Center and Weill Medical College of Cornell University
name: Vijay Anand, MD
role: PRINCIPAL_INVESTIGATOR
References: