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)

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.

Study Overview

• Status: Completed
• Conditions: Eustachian Tube Dysfunction
• Intervention / Treatment: Device: Acclarent Eustachian Tube Balloon Catheter (ETBC)

• Study Type: Interventional
• Enrollment (Actual): 323
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • East Palo Alto, California, United States, 94303
      • California Ear Institute
  • District of Columbia
    • Washington, District of Columbia, United States, 20006
      • George Washington Medical Faculty Associates, ENT Center
  • Florida
    • Boca Raton, Florida, United States, 33487
      • ENT of South Florida
    • Boynton Beach, Florida, United States, 33437
      • ENT of South Florida
    • Sarasota, Florida, United States, 34239
      • Florida Ear & Sinus Center
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • ENT of Georgia
    • Atlanta, Georgia, United States, 30309
      • Piedmont Ear, Nose & Throat &Related Allergy
  • Indiana
    • Lebanon, Indiana, United States, 46052
      • Witham Health Services
  • Louisiana
    • Alexandria, Louisiana, United States, 71303
      • Red River Sinus Center
    • Baton Rouge, Louisiana, United States, 70808
      • Our Lady of the Lake Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Children's Hospital
  • Minnesota
    • Saint Paul, Minnesota, United States, 55130
      • Health Partners Specialty Center
  • Mississippi
    • Ocean Springs, Mississippi, United States, 39564
      • The Sinus Center of the South
  • New York
    • New York, New York, United States, 10021
      • Vijay Anand, LLC
    • Port Jefferson, New York, United States, 11777
      • Ear, Nose, Throat and Allergy Associates, LLP
    • White Plains, New York, United States, 10601
      • Ear, Nose, Throat and Allergy Associates, LLP
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • Charlotte Eye, Ear, Nose &Throat Associates
    • Raleigh, North Carolina, United States, 27609
      • Carolina Ear and Hearing Clinic
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Texas Healthcare, PLLC
    • San Antonio, Texas, United States, 78240
      • Ear Medical Group
  • Wisconsin
    • Monona, Wisconsin, United States, 53716
      • Meriter Monona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Medical management (MM); Medical management will consist of 6 weeks of daily intranasal steroid (triamcinolone acetonide)
Experimental: Eustachian tube balloon catheter (ETBC) plus MM; Eustachian tube dilation with the ETBC plus medical management	Device: Acclarent Eustachian Tube Balloon Catheter (ETBC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Efficacy Endpoint: Number of Randomized Subjects With MID Improvement From Baseline of 0.5 Points or More at 6 Weeks	The secondary efficacy endpoint will consist of comparison of subjects achieving at least a minimally important difference (MID) level improvement of 0.5 points on the ETDQ-7 at 6 weeks post-treatment in the investigational arm versus the proportion of subjects achieving at least an MID level improvement on the ETDQ-7 at 6 weeks post-randomization in the control arm The ETDQ-7 is a seven-item ETD specific validated quality of life survey. A mean item score of greater or equal to 2.1 indicates the presence of ETD.	6 Week Follow-Up Visit

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory Endpoint: Number of Randomized Subjects With Normalized Tympanometry at 12.24,52 Weeks	Evaluation of subjects experiencing normalization of tympanometry at 12 weeks, 24 weeks, and 52 weeks post-treatment in the investigational arm and evaluation of subjects experiencing normalization of tympanometry at 12 weeks, 24 weeks, and 52 weeks post-randomization in the control arm. As MM subjects were allowed to receive a crossover procedure after their 6-week follow-up visit, there is a limited number of MM subjects who completed the 12/24/52 visits.	12, 24, 52 Week Follow-Up
Exploratory Endpoint: Number of Randomized Subjects With ETDQ-7 Improvement at 12, 24, 52 Weeks	Evaluation of subjects achieving at least a MID level improvement of 0.5 points at 12 weeks, 24 weeks, and 52 weeks post-treatment in the investigational arm and evaluation of subjects achieving at least a MID level improvement at 12 weeks, 24 weeks, and 52 weeks post-randomization in the control arm. As MM subjects were allowed to receive a crossover procedure after their 6-week follow-up visit, there is a limited number of MM subjects who completed the 12/24/52 visits.	12,24,52 Week Follow-Up Visit
Exploratory Endpoint: WPAI at 6,12,24,52 Weeks	Evaluation of subjects' work and activity impairment before and after treatment in both the investigational arm and the control arm. The Work Productivity and Activity Impairment (WPAI) questionnaire is a 6-question patient-reported general health assessment of productivity and activity impairment. WPAI results are expressed as the percentage of impairment from 0 to 100 where higher numbers indicate greater impairment or less productivity. Due to an error in the WPAI electronic data collection form, 2 questions were not visible to many subjects resulting in a significant amount of missing data for all scores except non-work activity impairment. Therefore, only the non-work activity impairment results are presented. As MM subjects were allowed to receive a crossover procedure after their 6-week follow-up visit, there is a limited number of MM subjects who completed the 12/24/52 visits.	6,12,24,52 Week Follow-Up

Collaborators and Investigators

• Sponsor: Integra LifeSciences Corporation
• Collaborators: Acclarent
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): January 12, 2017

Study Registration Dates

• First Submitted: March 6, 2014
• First Submitted That Met QC Criteria: March 12, 2014
• First Posted (Estimated): March 14, 2014

Study Record Updates

• Last Update Posted (Actual): July 12, 2024
• Last Update Submitted That Met QC Criteria: July 10, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CPR005029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: A publication is planned

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes