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Trial registered on ANZCTR


Registration number
ACTRN12624000431527p
Ethics application status
Submitted, not yet approved
Date submitted
16/03/2024
Date registered
9/04/2024
Date last updated
9/04/2024
Date data sharing statement initially provided
9/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Safety and performance of the Infinity balloon dilator for people with upper esophageal sphincter obstruction
Scientific title
Safety and Efficacy of the Infinity Figure 8 balloon dilator for Improvement of Swallowing in Patients with Upper esophageal sphincter obstruction
Secondary ID [1] 311554 0
nil known
Universal Trial Number (UTN)
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dysphagia 332917 0
Upper esophageal sphincter dysfunction 332918 0
Condition category
Condition code
Oral and Gastrointestinal 329630 329630 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Surgery 329631 329631 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
INTERVENTION: Balloon dilation of the upper esophageal sphincter using a new shaped dilator (dumbbell shaped, figure-of-8).
Participants with obstructive dysfunction of the upper oesophageal sphincter (UES) will be offered balloon dilation. They may choose from a standard round balloon or a new dumbbell shaped balloon. Under either local anaesthesia or general anaesthesia, a flexible endoscope will be used to site a guide wire through the UES into the stomach. This will be used to thread a balloon dilator onto, and across the UES region. The balloon will be inflated for 60s and held, then deflated completely. A second inflation of 45-60s may be performed depending on the first response. Then all instruments and the balloon dilator are removed.
This will take place largely in the operating room but some patients may opt for the procedure under local anaesthetic in the clinic. The procedure is performed by Dr Allen, an Otolaryngologist.

Allocation of balloon shaped to each patient is by patient preference.

Follow up videofluoroscopy will be performed to analyse opening of the upper esophageal sphincter.
Intervention code [1] 328209 0
Treatment: Devices
Comparator / control treatment
Balloon dilation with standard round balloon:
Participants with obstructive dysfunction of the upper oesophageal sphincter (UES) will be offered balloon dilation. They may choose from a standard round balloon or a new dumbbell shaped balloon. Under either local anaesthesia or general anaesthesia, a flexible endoscope will be used to site a guide wire through the UES into the stomach. This will be used to thread a balloon dilator onto, and across the UES region. The balloon will be inflated for 60s and held, then deflated completely. A second inflation of 45-60s may be performed depending on the first response. Then all instruments and the balloon dilator are removed.
This will take place largely in the operating room but some patients may opt for the procedure under local anaesthetic in the clinic. The procedure is performed by Dr Allen, an Otolaryngologist.
Follow up videofluoroscopy will be performed to analyse opening of the upper esophageal sphincter.
Control group
Active

Outcomes
Primary outcome [1] 337699 0
Patient reported swallowing ability
Timepoint [1] 337699 0
EAT score will be obtained at eight weeks, 12 weeks (primary endpoint), 26 and 52 weeks post-dilatation..
Primary outcome [2] 337700 0
Quantitative videofluoroscopic assessment of swallowing
Timepoint [2] 337700 0
Videofluoroscopic measures will be obtained at eight weeks post-dilatation.
Secondary outcome [1] 432898 0
satisfaction with procedure
Timepoint [1] 432898 0
Likert scale scores will be collected at clinic visits at eight, 12, 26, and 52 weeks post-dilatation.

Eligibility
Key inclusion criteria
1) Oropharyngeal dysphagia (with or without feeding tube) due to upper esophageal sphincter (UES) dysfunction, of greater than 3 months duration, as documented by fluoroscopic swallow study.
2) Age 18 years and over
3) Diminished upper esophageal sphincter (UES) opening defined as less than .55 cm for individuals less than 65 years of age and less than .40 cm for individuals over 65 years of age on lateral images of fluoroscopic swallow study.
4) Failure of dysphagia therapy prior to study enrollment.
5) Able to undergo a short general anaesthetic or willing to attempt dilation under local anaesthetic in the office.
6) Ability to understand the informed consent and comply with follow-up, as evidenced by appropriate questions, responses, and comments during the initial evaluations.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Oropharyngeal dysphagia not related to upper esophageal sphincter (UES) dysfunction.
2) Esophageal phase dysphagia as defined through personal history and/or documented diagnosis of esophageal dysmotility, hiatal hernia, eosinophilic esophagitis, malignant esophageal disease, erosive peptic esophagitis, and/or systemic disease affecting the esophagus.
3) Normal UES opening, as evidenced by UES opening greater than .55 cm for individuals under 65 years of age and greater than .40 cm for individuals over 65 years of age on fluoroscopic swallow study.
4). Age less than 18 years
5) Not having received dysphagia therapy
6) Malignant disease present in the oropharynx
7) Active tumor involving the cricoid or laryngeal cartilage.
8) Patients with orocutaneous or pharyngocutaneous fistulae at the time of evaluation.
9) Patients with current, at the time of evaluation, and/or documented history of subglottic stenosis, as evidenced on endoscopy (airway issues should be addressed prior to general anaesthesia).
10) Patients with current, at the time of evaluation, and/or documented history of airway obstruction, as evidenced on endoscopy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Pre- and post-treatment t-tests, multivariate analysis between groups using ANOVA and regression analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/04/2024
Actual
Date of last participant enrolment
Anticipated
3/03/2025
Actual
Date of last data collection
Anticipated
31/03/2026
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 26205 0
New Zealand
State/province [1] 26205 0

Funding & Sponsors
Funding source category [1] 315852 0
Hospital
Name [1] 315852 0
North Shore Hospital, Te Whatu Ora Waitemata
Country [1] 315852 0
New Zealand
Primary sponsor type
Hospital
Name
Te Whatu Ora Waitemata
Address
Country
New Zealand
Secondary sponsor category [1] 317986 0
Commercial sector/Industry
Name [1] 317986 0
Bryan Medical
Address [1] 317986 0
Country [1] 317986 0
United States of America

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314705 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 314705 0
https://ethics.health.govt.nz/about/central-health-and-disability-ethics-committee/
Ethics committee country [1] 314705 0
New Zealand
Date submitted for ethics approval [1] 314705 0
05/03/2024
Approval date [1] 314705 0
Ethics approval number [1] 314705 0

Summary
Brief summary
To compare the benefits of using a new dumbbell shaped balloon dilator to expand the upper esophageal sphincter compared with the traditional round shaped balloon. The rest of the procedure will be the same. The dumbbell shape is more similar to the physiological shape of the UES normally, and can reach further side to side to treat scar tissues that form at the edges of the sphincter.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132458 0
A/Prof Jacqueline Allen
Address 132458 0
Auckland ENT Group, 242 Great South Road, Greenlane, Auckland 1051
Country 132458 0
New Zealand
Phone 132458 0
+64 21897444
Fax 132458 0
Email 132458 0
[email protected]
Contact person for public queries
Name 132459 0
Jacqueline Allen
Address 132459 0
Auckland ENT Group, 242 Great South Road, Greenlane, Auckland 1051
Country 132459 0
New Zealand
Phone 132459 0
+64 21897444
Fax 132459 0
Email 132459 0
[email protected]
Contact person for scientific queries
Name 132460 0
Jacqueline Allen
Address 132460 0
Auckland ENT Group, 242 Great South Road, Greenlane, Auckland 1051
Country 132460 0
New Zealand
Phone 132460 0
+64 21897444
Fax 132460 0
Email 132460 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
varying treatment courses prior to the dilation will make isolated data unhelpful to other researchers


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21883Other    From published papers once the study has been comp... [More Details]



Results publications and other study-related documents

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