Study of Safety and Efficacy for the Eustachian Tube Balloon Catheter

Eustachian Tube Dysfunction Clinical Trial

— ELLIOTT  

Official title:

A Randomized Clinical Study of Safety and Efficacy for the Eustachian Tube Balloon Catheter (ELLIOTT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02087150
• Other study ID #: CPR005029
• Status: Completed
• Phase: N/A
• Start date: February 1, 2014
• Est. completion date: January 12, 2017

Study information

• Verified date: December 2018
• Source: Acclarent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 323
• Est. completion date: January 12, 2017
• Est. primary completion date: December 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eustachian Tube Dysfunction

Intervention

Device:
• Acclarent Eustachian Tube Balloon Catheter (ETBC)

Locations

Country	Name	City	State
United States	Red River Sinus Center	Alexandria	Louisiana
United States	ENT of Georgia	Atlanta	Georgia
United States	Piedmont Ear, Nose & Throat &Related Allergy	Atlanta	Georgia
United States	Our Lady of the Lake Hospital	Baton Rouge	Louisiana
United States	ENT of South Florida	Boca Raton	Florida
United States	Children's Hospital	Boston	Massachusetts
United States	ENT of South Florida	Boynton Beach	Florida
United States	Charlotte Eye, Ear, Nose &Throat Associates	Charlotte	North Carolina
United States	California Ear Institute	East Palo Alto	California
United States	Texas Healthcare, PLLC	Fort Worth	Texas
United States	Witham Health Services	Lebanon	Indiana
United States	Meriter Monona	Monona	Wisconsin
United States	Vijay Anand, LLC	New York	New York
United States	The Sinus Center of the South	Ocean Springs	Mississippi
United States	Ear, Nose, Throat and Allergy Associates, LLP	Port Jefferson	New York
United States	Carolina Ear and Hearing Clinic	Raleigh	North Carolina
United States	Health Partners Specialty Center	Saint Paul	Minnesota
United States	Ear Medical Group	San Antonio	Texas
United States	Florida Ear & Sinus Center	Sarasota	Florida
United States	George Washington Medical Faculty Associates, ENT Center	Washington	District of Columbia
United States	Ear, Nose, Throat and Allergy Associates, LLP	White Plains	New York

Sponsors (1)

Lead Sponsor	Collaborator
Acclarent

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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	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