Study of Safety and Efficacy for the Eustachian Tube Balloon Catheter
ELLIOTT
A Randomized Clinical Study of Safety and Efficacy for the Eustachian Tube Balloon Catheter (ELLIOTT)
1 other identifier
interventional
323
1 country
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2014
Typical duration for not_applicable
21 active sites
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
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 6, 2014
CompletedFirst Posted
Study publicly available on registry
March 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 12, 2017
CompletedResults Posted
Study results publicly available
January 8, 2019
CompletedJuly 12, 2024
July 1, 2024
2.8 years
March 6, 2014
July 27, 2018
July 10, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Primary Efficacy Analysis: Number of Randomized Subjects With Tympanogram Normalization at 6 Weeks
The primary efficacy analysis compares randomized subjects with tympanogram normalization (Types B or C normalized to Type A) in all indicated ears at 6 weeks in the investigational arm versus the control arm. Per protocol, tympanogram types are defined as follows: Type A: Peak compliance occurs between +50 and -100 daPa, with minimum peak height of 0.2ml. Indicates NORMAL middle ear function Type B: No sharp peak and a rounded line. Indicates ABNORMAL middle ear function Type C: Peak compliance occurs beyond -100 daPa. Indicates ABNORMAL middle ear function
6 Week Follow-Up Visit
Secondary Outcomes (1)
Secondary Efficacy Endpoint: Number of Randomized Subjects With MID Improvement From Baseline of 0.5 Points or More at 6 Weeks
6 Week Follow-Up Visit
Other Outcomes (3)
Exploratory Endpoint: Number of Randomized Subjects With Normalized Tympanometry at 12.24,52 Weeks
12, 24, 52 Week Follow-Up
Exploratory Endpoint: Number of Randomized Subjects With ETDQ-7 Improvement at 12, 24, 52 Weeks
12,24,52 Week Follow-Up Visit
Exploratory Endpoint: WPAI at 6,12,24,52 Weeks
6,12,24,52 Week Follow-Up
Study Arms (2)
Medical management (MM)
NO INTERVENTIONMedical management will consist of 6 weeks of daily intranasal steroid (triamcinolone acetonide)
Eustachian tube balloon catheter (ETBC) plus MM
EXPERIMENTALEustachian tube dilation with the ETBC plus medical management
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Integra LifeSciences Corporationlead
- Acclarentcollaborator
Study Sites (21)
California Ear Institute
East Palo Alto, California, 94303, United States
George Washington Medical Faculty Associates, ENT Center
Washington D.C., District of Columbia, 20006, United States
ENT of South Florida
Boca Raton, Florida, 33487, United States
ENT of South Florida
Boynton Beach, Florida, 33437, United States
Florida Ear & Sinus Center
Sarasota, Florida, 34239, United States
ENT of Georgia
Atlanta, Georgia, 30308, United States
Piedmont Ear, Nose & Throat &Related Allergy
Atlanta, Georgia, 30309, United States
Witham Health Services
Lebanon, Indiana, 46052, United States
Red River Sinus Center
Alexandria, Louisiana, 71303, United States
Our Lady of the Lake Hospital
Baton Rouge, Louisiana, 70808, United States
Children's Hospital
Boston, Massachusetts, 02115, United States
Health Partners Specialty Center
Saint Paul, Minnesota, 55130, United States
The Sinus Center of the South
Ocean Springs, Mississippi, 39564, United States
Vijay Anand, LLC
New York, New York, 10021, United States
Ear, Nose, Throat and Allergy Associates, LLP
Port Jefferson, New York, 11777, United States
Ear, Nose, Throat and Allergy Associates, LLP
White Plains, New York, 10601, United States
Charlotte Eye, Ear, Nose &Throat Associates
Charlotte, North Carolina, 28210, United States
Carolina Ear and Hearing Clinic
Raleigh, North Carolina, 27609, United States
Texas Healthcare, PLLC
Fort Worth, Texas, 76104, United States
Ear Medical Group
San Antonio, Texas, 78240, United States
Meriter Monona
Monona, Wisconsin, 53716, United States
Related Publications (1)
Swords C, Smith ME, Patel A, Norman G, Llewellyn A, Tysome JR. Balloon dilatation of the Eustachian tube for obstructive Eustachian tube dysfunction in adults. Cochrane Database Syst Rev. 2025 Feb 26;2(2):CD013429. doi: 10.1002/14651858.CD013429.pub2.
PMID: 40008607DERIVED
Results Point of Contact
- Title
- Patricia Chen
- Organization
- Acclarent
Study Officials
- PRINCIPAL INVESTIGATOR
Dennis Poe, MD, PhD
Boston Children's Hospital
- PRINCIPAL INVESTIGATOR
Vijay Anand, MD
Memorial Sloan Kettering Cancer Center and Weill Medical College of Cornell University
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- 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
March 6, 2014
First Posted
March 14, 2014
Study Start
February 1, 2014
Primary Completion
December 1, 2016
Study Completion
January 12, 2017
Last Updated
July 12, 2024
Results First Posted
January 8, 2019
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will share
A publication is planned