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

July 10, 2024 updated by: Integra LifeSciences Corporation

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
323

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary Efficacy Analysis: Number of Randomized Subjects With Tympanogram Normalization at 6 Weeks
Time Frame: 6 Week Follow-Up Visit
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Time Frame: 6 Week Follow-Up Visit
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Exploratory Endpoint: Number of Randomized Subjects With Normalized Tympanometry at 12.24,52 Weeks
Time Frame: 12, 24, 52 Week Follow-Up
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
Time Frame: 12,24,52 Week Follow-Up Visit
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
Time Frame: 6,12,24,52 Week Follow-Up
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Integra LifeSciences Corporation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Acclarent

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 12, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 14, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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