Chronic Eustachian SalpingitisNCT04055714
Feasibility of Balloon Dilation of the Eustachian Tubes Under Local Anesthesia
A study testing Balloon dilation of the Eustachian tubes in people with Chronic Eustachian Salpingitis, run by Piedmont Ear, Nose, Throat and Related Allergy, PC.
Trial summary
The objective of this study is to demonstrate that balloon dilation of the Eustachian tubes can be done successfully for treatment of chronic dilatory Eustachian tube dysfunction under local anesthesia with acceptable patient discomfort levels. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Eustachian Salpingitis
- What is being tested?
- Balloon dilation of the Eustachian tubes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Oct 2019to Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult male or female aged 22 years and older
- Persistent ETD as defined by patient-reported symptoms of ETD (including pressure and/or pain and/or clogged and/or muffled sensation in the affected ear(s)) for no less than 12 weeks prior to enrollment, and at least one of the following confirmatory indicators of persistent ETD no less than 12 weeks prior to enrollment B1: Confirmation from referring physician that the subject has experienced persistent ETD symptoms (including pressure and/or pain and/or clogged and or muffled sensation in the affected ear(s)) during an office visit no less than 12 weeks prior to enrollment. Persistent symptoms must be confirmed as not waxing and waning. OR B2: Documented evidence in the ENT physician records that the subject has experienced persistent ETD symptoms (including pressure and/or pain and/or clogged and/or muffled sensation in the affected ear(s)) during an office visit no less than 12 weeks prior to enrollment. Persistent symptoms must be confirmed as not waxing and waning. OR B3: Type B or Type C tympanogram in at least one ear no less than 12 weeks prior to enrollment. OR B4: Otoscopic exam demonstrating TM retraction and/or middle ear fluid no less than 12 weeks prior to enrollment.
- Failure of appropriate medical management consisting of either a minimum of 4 weeks of continuous daily usage of any intranasal steroid spray (INS) or a minimum of one completed course of an oral steroid, per the investigator's choice. The failed medical management may occur any time within 90 days prior to study enrollment.
- A positive diagnosis of persistent (i.e. not waxing and waning) ETD, as confirmed with both of the following:
- D1: Abnormal tympanometry (defined as either Type B or Type C) after failed medical management and within 14 days of study enrollment D2: Symptomatic dysfunction as documented by a Eustachian Tube Dysfunction Questionnaire (ETDQ-7) mean item score ≥ 2.1 after failed medical management
- Absence of internal carotid artery (ICA) dehiscence into the ET lumen on both sides as confirmed by a computed tomography (CT scan) including temporal bone - to include paranasal sinuses when clinically appropriate
Who cannot join
- Females who are pregnant or lactating
- Anatomy that requires an adjunctive surgical procedure on the same day as ETBC surgery to allow balloon catheter access to the ET (e.g. septoplasty, polypectomy, turbinate reduction)
- Concomitant nasal or sinus procedures planned on the same day as ETBC surgery or any time during study participation (e.g. adenoidectomy, sinus surgery)
- Concomitant ear procedures planned on the same day as ETBC surgery or any time during study participation (e.g. myringotomy, tympanostomy tube placement)
- History of major surgery of the head or neck within four (4) months prior to enrollment (e.g. adenoidectomy, sinus surgery)
- History of a patulous ET in either ear
Show all 22Show fewer
- History of fluctuating sensorineural hearing loss, in either ear, within the past 5 years, as evidenced by a 20dB change in 3 pure tone average frequencies
- Active chronic or acute otitis media (AOM), in either ear, as evidenced by bulging TM, erythema, purulent effusion, or cholesteatoma
- Tympanic membrane perforation or presence of a tympanostomy tube in either ear
- Tympanosclerosis with opacification of ≥50% of tympanic membrane in either ear
- Evidence of acute upper respiratory infection
- Evidence of active Temporomandibular joint disorder (TMJ) per clinical exam (i.e. pain with mouth opening, chewing, clenching; tenderness to palpation deep into the glenoid capsule on wide mouth opening, especially with right and left lateral movements of the jaw; tenderness of the masseter or lateral pterygoid muscles on bimanual intra/extraoral examination)
- Cleft palate or history of cleft palate repair
- Craniofacial syndrome, including Down's Syndrome
- Cystic fibrosis
- Ciliary dysmotility syndrome
- Other systemic mucosal diseases or immunodeficiency disorders (e.g. Samters triad, Sarcoidosis, Wegener's granulomatosis), including patients actively taking immunosuppressive drugs
- Intolerance of protocol-defined medication regimen
- Prior surgical intervention on Eustachian tube including balloon dilation, laser or mechanical tuboplasty
- Absence of dilatory muscular contractions (tensor veli palatini or levator veli palatini failure, severe dysfunction) as assessed by endoscopic observation of swallows and yawns
- Treatment is planned for one ear, but the opposite ear has normal (Type A) tympanogram and the subject complains of ETD symptoms in that ear
- Treatment is planned for one ear, but the opposite ear has abnormal (Type B or C) tympanogram and the subject has no complaints of ETD symptoms in that ear (asymptomatic)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Feasibility of Balloon Dilation of the Eustachian Tubes for Dilatory Dysfunction Under Local Anesthesia
The objective of this study is to demonstrate that balloon dilation of the Eustachian tubes can be done successfully for treatment of chronic dilatory Eustachian tube dysfunction under local anesthesia with acceptable patient discomfort levels.
Read the detailed description
This study is a prospective, non-significant risk, multi-center trial of patients with Eustachian tube dysfunction who are refractory to medical management. Patients will undergo balloon dilation of the Eustachian tubes in the office under local anesthesia. We will assess assess the peri-procedural and post-procedure pain levels, and determine the proportion of subjects experiencing normalization of tympanometry and improvement in quality of of life at 6 weeks, 12 weeks, and 52 weeks post-treatment.
- Conditions
- Chronic Eustachian Salpingitis
- Being tested
- Balloon dilation of the Eustachian tubes
- Keywords
- Eustachian tube dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon dilation of the Eustachian tubesDevice
Use the Aera Balloon through the nose to dilate the Eustachian tubes
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Balloon dilation of the Eustachian Tube(s) with Acclarent Aera Balloon Receives: Device: Balloon dilation of the Eustachian tubes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Pain Assessment Scale to describe procedural pain
Assess peri-procedural pain levels with a visual pain assessment scale. The scale has numbering from 0-10 with associated visual pictures that correspond to the degree of pain. Participants will number their pain level and describe the location of pain (ear, nose, forehead, jaw, teeth).
Measured: during procedure
Visual Pain Assessment Scale to describe postoperative pain
Assess post-procedural pain levels with a visual pain assessment scale. The scale has numbering from 0-10 with associated visual pictures that correspond to the degree of pain. Participants will number their pain level and describe the location of pain (ear, nose, forehead, jaw, teeth).
Measured: 2 weeks after procedure
Visual Pain Assessment Scale to describe postoperative pain
Assess post-procedural pain levels with a visual pain assessment scale. The scale has numbering from 0-10 with associated visual pictures that correspond to the degree of pain. Participants will number their pain level and describe the location of pain (ear, nose, forehead, jaw, teeth).
Measured: 6 weeks after procedure
Visual Pain Assessment Scale to describe postoperative pain
Assess post-procedural pain levels with a visual pain assessment scale. The scale has numbering from 0-10 with associated visual pictures that correspond to the degree of pain. Participants will number their pain level and describe the location of pain (ear, nose, forehead, jaw, teeth).
Measured: 52 weeks after procedure
Secondary outcomes (2)
Tympanometry - an objective measure of the negative pressure in the middle ear
proportion of subjects experiencing normalization of tympanometry post-treatment, indicating improvement or resolution in the negative pressure in the middle ear.
Measured: 6 weeks after procedure
Tympanometry - an objective measure of the negative pressure in the middle ear
proportion of subjects experiencing normalization of tympanometry post-treatment, indicating improvement or resolution in the negative pressure in the middle ear.
Measured: 52 weeks after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study startOct 2019 (estimated)
- Primary completionOct 2020 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Eustachian SalpingitisStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- prospective, non-significant risk, multi-center, non-controlled trial
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Piedmont Ear, Nose, Throat and Related Allergy, PC
- Sponsor type
- University, hospital or other
- Collaborators
- Acclarent
- Responsible party
- Sponsor
- Investigators
- Karen Hoffmann, MD, Principal investigator, Piedmont Ear, Nose, Throat & Related Allergy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04055714
- Sponsor's protocol ID
- IIS A-016
- Status last verified
- Aug 2019
- First submitted
- 3 Aug 2019
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Balloon Dilation of the Eustachian Tubes for Dilatory Dysfunction Under Local Anesthesia
- ClinicalTrials.gov ID
- NCT04055714
- Acronym / sponsor ID
- IIS A-016
- Conditions
- Chronic Eustachian Salpingitis
- Keywords
- Eustachian tube dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Piedmont Ear, Nose, Throat and Related Allergy, PCUniversity, hospital or other
- Collaborators
- Acclarent
- Study start
- Oct 2019 (estimated)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 14 Aug 2019 (actual)
- Results
- Not posted in the source record
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 demonstrate that balloon dilation of the Eustachian tubes can be done successfully for treatment of chronic dilatory Eustachian tube dysfunction under local anesthesia with acceptable patient discomfort levels.
Detailed description
This study is a prospective, non-significant risk, multi-center trial of patients with Eustachian tube dysfunction who are refractory to medical management. Patients will undergo balloon dilation of the Eustachian tubes in the office under local anesthesia. We will assess assess the peri-procedural and post-procedure pain levels, and determine the proportion of subjects experiencing normalization of tympanometry and improvement in quality of of life at 6 weeks, 12 weeks, and 52 weeks post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective, non-significant risk, multi-center, non-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Device: Balloon dilation of the Eustachian tubesBalloon dilation of the Eustachian Tube(s) with Acclarent Aera Balloon |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult male or female aged 22 years and older
- Persistent ETD as defined by patient-reported symptoms of ETD (including pressure and/or pain and/or clogged and/or muffled sensation in the affected ear(s)) for no less than 12 weeks prior to enrollment, and at least one of the following confirmatory indicators of persistent ETD no less than 12 weeks prior to enrollment B1: Confirmation from referring physician that the subject has experienced persistent ETD symptoms (including pressure and/or pain and/or clogged and or muffled sensation in the affected ear(s)) during an office visit no less than 12 weeks prior to enrollment. Persistent symptoms must be confirmed as not waxing and waning. OR B2: Documented evidence in the ENT physician records that the subject has experienced persistent ETD symptoms (including pressure and/or pain and/or clogged and/or muffled sensation in the affected ear(s)) during an office visit no less than 12 weeks prior to enrollment. Persistent symptoms must be confirmed as not waxing and waning. OR B3: Type B or Type C tympanogram in at least one ear no less than 12 weeks prior to enrollment. OR B4: Otoscopic exam demonstrating TM retraction and/or middle ear fluid no less than 12 weeks prior to enrollment.
- Failure of appropriate medical management consisting of either a minimum of 4 weeks of continuous daily usage of any intranasal steroid spray (INS) or a minimum of one completed course of an oral steroid, per the investigator's choice. The failed medical management may occur any time within 90 days prior to study enrollment.
- A positive diagnosis of persistent (i.e. not waxing and waning) ETD, as confirmed with both of the following:
- D1: Abnormal tympanometry (defined as either Type B or Type C) after failed medical management and within 14 days of study enrollment D2: Symptomatic dysfunction as documented by a Eustachian Tube Dysfunction Questionnaire (ETDQ-7) mean item score ≥ 2.1 after failed medical management
Key exclusion criteria (22 listed)
- Females who are pregnant or lactating
- Anatomy that requires an adjunctive surgical procedure on the same day as ETBC surgery to allow balloon catheter access to the ET (e.g. septoplasty, polypectomy, turbinate reduction)
- Concomitant nasal or sinus procedures planned on the same day as ETBC surgery or any time during study participation (e.g. adenoidectomy, sinus surgery)
- Concomitant ear procedures planned on the same day as ETBC surgery or any time during study participation (e.g. myringotomy, tympanostomy tube placement)
- History of major surgery of the head or neck within four (4) months prior to enrollment (e.g. adenoidectomy, sinus 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 |
|---|---|---|
| Balloon dilation of the Eustachian tubesUse the Aera Balloon through the nose to dilate the Eustachian tubes | Device | Treatment arm |
Primary outcome
Visual Pain Assessment Scale to describe procedural pain
Time frame: during procedure
Assess peri-procedural pain levels with a visual pain assessment scale. The scale has numbering from 0-10 with associated visual pictures that correspond to the degree of pain. Participants will number their pain level and describe the location of pain (ear, nose, forehead, jaw, teeth).
Visual Pain Assessment Scale to describe postoperative pain
Time frame: 2 weeks after procedure
Assess post-procedural pain levels with a visual pain assessment scale. The scale has numbering from 0-10 with associated visual pictures that correspond to the degree of pain. Participants will number their pain level and describe the location of pain (ear, nose, forehead, jaw, teeth).
Visual Pain Assessment Scale to describe postoperative pain
Time frame: 6 weeks after procedure
Assess post-procedural pain levels with a visual pain assessment scale. The scale has numbering from 0-10 with associated visual pictures that correspond to the degree of pain. Participants will number their pain level and describe the location of pain (ear, nose, forehead, jaw, teeth).
Visual Pain Assessment Scale to describe postoperative pain
Time frame: 52 weeks after procedure
Assess post-procedural pain levels with a visual pain assessment scale. The scale has numbering from 0-10 with associated visual pictures that correspond to the degree of pain. Participants will number their pain level and describe the location of pain (ear, nose, forehead, jaw, teeth).
2 secondary outcomes
Tympanometry - an objective measure of the negative pressure in the middle ear
Time frame: 6 weeks after procedure
Tympanometry - an objective measure of the negative pressure in the middle ear
Time frame: 52 weeks after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- 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: No
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.
Karen Hoffmann, MD principal investigator
Piedmont Ear, Nose, Throat & Related Allergy
Questions about this trial
What is this clinical trial studying?
A study testing Balloon dilation of the Eustachian tubes in people with Chronic Eustachian Salpingitis, run by Piedmont Ear, Nose, Throat and Related Allergy, PC.
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 22 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: status not confirmed, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Study Coordinator (404-351-5045, PiedmontENTResearch@piedent.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Pain Assessment Scale to describe procedural pain (time frame: during procedure). The study lists 4 primary outcomes in all. 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 NCT04055714, 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 14 Aug 2019.