Eustachian Tube DysfunctionELLIOTTNCT02087150

Study of Safety and Efficacy for the Eustachian Tube Balloon Catheter

A study testing Acclarent Eustachian Tube Balloon Catheter (ETBC) in people with Eustachian Tube Dysfunction, run by Integra LifeSciences Corporation at 21 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 22 years and older
Conditions the study is for: Eustachian Tube Dysfunction
What is being tested?: Acclarent Eustachian Tube Balloon Catheter (ETBC)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 323 participants
Where: 21 sitesUnited States
Study dates: 1 Feb 2014to 12 Jan 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 19Show fewer

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

Trial locations and contacts

21 sites in 1 country.

City, postcode or hospital

21 sites in 1 country

United States21 sites

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

Other trials in United States

About this study

Official title: 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.

Conditions: Eustachian Tube Dysfunction
Being tested: Acclarent Eustachian Tube Balloon Catheter (ETBC)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Acclarent Eustachian Tube Balloon Catheter (ETBC)Device

Study groups in NCT02087150
Study group	Role	What they receive
Medical management (MM)	No intervention	Medical management will consist of 6 weeks of daily intranasal steroid (triamcinolone acetonide)
Eustachian tube balloon catheter (ETBC) plus MM	Experimental	Eustachian tube dilation with the ETBC plus medical management Receives: Device: Acclarent Eustachian Tube Balloon Catheter (ETBC)

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
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.
Measured: 6 Week Follow-Up Visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 201412 Jan 2017

First posted14 Mar 2014 (estimated)
Study start1 Feb 2014
Primary completion1 Dec 2016
Study completion12 Jan 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Eustachian Tube DysfunctionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 323 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02087150
Sponsor's protocol ID: CPR005029
Acronym: ELLIOTT
Status last verified: Jul 2024
First submitted: 6 Mar 2014
Last updated: 12 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: A publication is planned

Publications

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.
PubMed 40008607

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Nasal Dilator Therapy for Patulous Eustachian Tube Dysfunction
Patulous Eustachian Tube Dysfunction, Eustachian Tube Dysfunction
Not yet recruiting
EarFlo: A Non-Invasive Treatment for Otitis Media With Effusion & Eustachian Tube Dysfunction in Adults
Otitis Media With Effusion (OME), Eustachian Tube Dysfunction
Not yet recruiting
Active vs. Passive VR During Office-based ENT Procedures
Pain, Anxiety
RecruitingObservational study
AERA Pediatrics Registry
Dysfunction of Eustachian Tube
Enrolling by invitationObservational study
Diagnostic Precision and Accuracy Using the Teed Scoring System Versus the O'Neill Grading System
Otic Barotrauma, Pressure Injury

All Eustachian Tube Dysfunction trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Clinical Study of Safety and Efficacy for the Eustachian Tube Balloon Catheter (ELLIOTT)
ClinicalTrials.gov ID: NCT02087150
Acronym / sponsor ID: ELLIOTT / CPR005029
Conditions: Eustachian Tube Dysfunction
Study type: Interventional
Recruitment status: Completed
Enrolment: 323 participants (actual)
Lead sponsor: Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
Collaborators: Acclarent
Study start: 1 Feb 2014 (actual)
Primary completion: 1 Dec 2016 (actual)
Study completion: 12 Jan 2017 (actual)
First posted: 14 Mar 2014 (estimated)
Results: Posted 8 Jan 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Medical management (MM)	No intervention	–Medical management will consist of 6 weeks of daily intranasal steroid (triamcinolone acetonide)
Eustachian tube balloon catheter (ETBC) plus MM	Experimental	Device: Acclarent Eustachian Tube Balloon Catheter (ETBC)Eustachian tube dilation with the ETBC plus medical management

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (19 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Acclarent Eustachian Tube Balloon Catheter (ETBC)	Device	Eustachian tube balloon catheter (ETBC) plus MM

Primary outcome

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

1 secondary outcome

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

Results and safety

Results posted to the registry on 8 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lead-In	81	71
Randomized ETBC	162	128
Randomized MM	80	69

Primary outcome: Primary Efficacy Analysis: Number of Randomized Subjects With Tympanogram Normalization at 6 Weeks

Time frame: 6 Week Follow-Up Visit. Count of participants. Unit: Participants

Measure	Randomized ETBC n = 143	Randomized MM n = 72
Value	73	10

Population analysed: Primary Analysis Cohort (PAC): The PAC is defined as all randomized subjects who receive a study treatment for which they are randomized and have completed their primary analysis visits (i.e. completer analysis with baseline and 6 week tympanogram).

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lead-In	2 of 80 (2.5%)	30 of 80 (37.5%)	0 of 80
Randomized ETBC	5 of 149 (3.4%)	58 of 149 (38.9%)	1 of 149
Crossover MM	0 of 70 (0%)	20 of 70 (28.6%)	0 of 70
ALL ETBC	7 of 299 (2.3%)	108 of 299 (36.1%)	1 of 299
Randomized MM	1 of 80 (1.3%)	18 of 80 (22.5%)	0 of 80

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40008607Swords 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.
Individual participant dataSharing planned: Yes. A publication is planned

Related trials for Eustachian Tube Dysfunction

Recruiting
Nasal Dilator Therapy for Patulous Eustachian Tube Dysfunction
Patulous Eustachian Tube Dysfunction, Eustachian Tube Dysfunction
Not yet recruiting
EarFlo: A Non-Invasive Treatment for Otitis Media With Effusion & Eustachian Tube Dysfunction in Adults
Otitis Media With Effusion (OME), Eustachian Tube Dysfunction
Not yet recruiting
Active vs. Passive VR During Office-based ENT Procedures
Pain, Anxiety
RecruitingObservational study
AERA Pediatrics Registry
Dysfunction of Eustachian Tube
Enrolling by invitationObservational study
Diagnostic Precision and Accuracy Using the Teed Scoring System Versus the O'Neill Grading System
Otic Barotrauma, Pressure Injury

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dennis Poe, MD, PhD principal investigator

Boston Children's Hospital

Vijay Anand, MD principal investigator

Memorial Sloan Kettering Cancer Center and Weill Medical College of Cornell University

21 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Acclarent Eustachian Tube Balloon Catheter (ETBC) in people with Eustachian Tube Dysfunction, run by Integra LifeSciences Corporation at 21 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Efficacy Analysis: Number of Randomized Subjects With Tympanogram Normalization at 6 Weeks (time frame: 6 Week Follow-Up Visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02087150, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.