Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000169145
Ethics application status
Approved
Date submitted
15/01/2019
Date registered
5/02/2019
Date last updated
28/09/2022
Date data sharing statement initially provided
5/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of the swallowing expansion device in subjects with severe swallowing difficulty.
Scientific title
Safety and Efficacy of the Swallow Expansion Device (SED) for Improvement
of Swallowing in Patients with Aspiration Secondary to Oropharyngeal
Dysphagia: A Single-Site, Open-Label, Phase I Human Trial
Secondary ID [1] 297083 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dysphagia 311090 0
Condition category
Condition code
Diet and Nutrition 309722 309722 0 0
Other diet and nutrition disorders
Oral and Gastrointestinal 310006 310006 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pilot study in which 5 subjects with severe swallow difficulty and aspiration that has failed all available treatment options will be implanted with a small plate-and-pin device (the Swallow Expansion Device, SED). This will be attached to the cricoid cartilage to allow for manual distraction of the upper oesophageal sphincter. Implantation will be performed under local anaesthetic. Eight weeks healing will be allowed before distraction begins. The SED may remain in place or be removed under local anaesthetic at any time. Implantation will be performed only by the Principle Investigator, a Fellowship trained Laryngologist.
Local anaesthetic used will be 0.5% bupivacaine with adrenaline (max volume 20ml) injected via 25G needle. Use of the device (after the specified bedding in time) will involve manual traction on the stem which will then pull the upper oesophageal sphincter open to allow for food passage. This requires some manual dexterity and ability to lift a 2kg weight (this is in the inclusion criteria).
Intervention code [1] 313358 0
Treatment: Devices
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 318690 0
Characterize the safety of the SED. Any implant infection, cricoid cartilage damage, implant rejection necessitating removal or other signs of irritation or injury will be noted. Assessments will be conducted by clinical examination with the researcher. Signs of infection, implant mobility, discomfort or migration will be noted. Need for explantation will be documented as a serious adverse event. Clinical self-rating questionnaires will be administered and collected as below in secondary outcomes.
Timepoint [1] 318690 0
Clinical assessments will be performed weekly for eight weeks post-implantation, then monthly to 12 months post-implantation.
Secondary outcome [1] 365738 0
Dysphagia specific quality of life assessed by subject self-rating the Eating Assessment Tool-10 questionnaire.
Timepoint [1] 365738 0
At enrollment and at 8 weeks, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 weeks post implantation
Secondary outcome [2] 366416 0
Swallowing safety as assessed by the Penetration Aspiration Scale score
Timepoint [2] 366416 0
At enrollment and at 8 weeks, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 weeks post implantation

Eligibility
Key inclusion criteria

1) Profound oropharyngeal dysphagia (with or without feeding tube) of greater than 12 months duration, as documented by the prevalence of aspiration on fluoroscopic swallow study.
2) Age > 18 years, acceptable forms of documentation for verification of age include birth certificate, passport, and/or driver’s license.
3) Diminished 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 fluoroscopic swallow study.
4) Failure of > 3 months of dysphagia therapy within 3 months of study enrollment.
5) No documented history of noncompliance with feeding recommendations.
6) Cognition that is within normal limits, as evidenced by a Mini Mental State Exam score greater than 25.
7) Manual dexterity that allows manipulation of the device.
8) Physical strength to pull the SED forward, as evidenced by the ability to lift a 2kg weight off of a table and keep it elevated for 10 seconds.
9) Ability to understand the informed consent and comply with follow-up, as evidenced by appropriate questions, responses, and comments during the initial evaluations.
10) Bilateral vocal fold mobility or unilateral vocal fold immobility in which the individual is able to attain complete glottic closure as evidenced on endoscopy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Profound oropharyngeal dysphagia < 12 months duration.
2) Esophageal phase dysphagia as defined as personal history and/or documented diagnosis of esophageal dysmotility, hiatal hernia, stricture, eosinophilic esophagitis, 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) Currently pregnant, as evidenced by a positive result on a pregnancy test if the patient is within child bearing age (younger than 45 years of age).
5) Age < 18 years
6) Not having received dysphagia therapy
7) Lack of manual dexterity to operate swallowing expansion device.
8) Inability to lift a 2kg weight off of a table and keep it elevated for 10 seconds.
9) Lack of cognitive ability to operate swallowing expansion device or provide informed consent.
10) Active tumor involving the cricoid or laryngeal cartilage.
11) Known allergic reaction to titanium as evidenced by personal history of allergic or adverse reaction to titanium.
12) Infection of cartilage, head, and/or neck at time of evaluation and/or implantation as documented by recent imaging study or abnormal physical examination.
13) Presence of a tracheotomy tube or airway obstruction necessitating a tracheotomy tube.
14) A documented history of noncompliance with recommendations or inability to attend follow up reviews. 15) Patients with an insensate larynx. Laryngeal sensation will be assessed with laryngopharyngeal sensory testing by laryngeal adductor reflex response on endoscopy.
16) Patients with a current, at the time of evaluation, and/or history of Zenker’s diverticulum.
17) Patients with sialorrhea at the time of evaluation with or without oral commissure incompetence.
18) Patients with profound xerostomia at the time of evaluation.
19) Patients with orocutaneous or pharyngocutaneous fistulae at the time of evaluation.
20) Patients with a current, at the time of evaluation, and/or history of immunosuppression, as defined by the patient having a diagnosed immunodeficiency disorder or on immunosuppressive medication.
21) Patients with a current, at the time of evaluation, and/or history of coagulopathy, as defined by the patient having a diagnosed coagulation disorder or on anticoagulation medication (e.g. baby aspirin, OTC non steroidal antinflammatories, herbal agents, Warfarin, clopidogrel) that cannot be temporarily stopped for the procedure.
22) Patients taking sedatives, narcotics, muscle-relaxants, anxiolytics, medical marijuana, alcohol, nicotine, medicinal nicotine, or other mind-altering medications that may affect safe patient use of the swallowing device.
23) Patients with bilateral vocal fold immobility in any position, as evidenced on endoscopy.
24) Patients with unilateral vocal fold immobility and unable to attain complete glottic closure, as evidenced on endoscopy.
25) Patients with current, at the time of evaluation, and/or documented history of subglottic stenosis, as evidenced on endoscopy.
26) Patients with current, at the time of evaluation, and/or documented history of airway obstruction, as evidenced on endoscopy.
27) Patients with a life expectancy < 2 years.

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)
Nil
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
nil
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
The initial feasibility study will include 5 patients. The cumulative incidence of SED implant infection or other complications, such as cricoid damage and/or implant rejection, related to the SED implant will be shown graphically by a Kaplan-Meier curve, and a six-monthly cumulative incidence of infection and complication will be estimated with 95% confidence intervals by a life-table approach. The same evaluation approaches will be used if the study was expanded to 20 subjects for two-years.
Mean UES opening, swallowing safety (PAS), and EAT-10 scores will be compared before and after placement of the implant by analysis of variance, treating examiner as a fixed effect and patient as a random effect to account for repeated measures. UES opening and PAS scores will be compared before and after anterior traction using analysis of variance as described above. All tests will be one-sided, as this study is designed for screening with interest only in detecting improvements in swallowing; tests will be at level 0.05, with Bonferroni correction for multiple comparison. Quality of life with the EAT-10 will be assessed at baseline, 3 months and at 24 months after device implantation.
Power calculation has been completed. Five patients will be recruited initially. This number of patients will give limited power but provide essential data to evaluate SED safety.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2019
Actual
9/09/2019
Date of last participant enrolment
Anticipated
31/10/2023
Actual
Date of last data collection
Anticipated
31/10/2024
Actual
Sample size
Target
5
Accrual to date
2
Final
Recruitment outside Australia
Country [1] 21199 0
New Zealand
State/province [1] 21199 0
Auckland

Funding & Sponsors
Funding source category [1] 301651 0
University
Name [1] 301651 0
University of California, Davis
Country [1] 301651 0
United States of America
Primary sponsor type
Hospital
Name
Waitemata District Health Board
Address
Hospital Rd,
Takapuna,
Auckland 0740
New Zealand
Country
New Zealand
Secondary sponsor category [1] 301362 0
None
Name [1] 301362 0
Address [1] 301362 0
Country [1] 301362 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302372 0
Central Health and Disabilities Ethics Committee
Ethics committee address [1] 302372 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
Ethics committee country [1] 302372 0
New Zealand
Date submitted for ethics approval [1] 302372 0
01/07/2013
Approval date [1] 302372 0
20/09/2013
Ethics approval number [1] 302372 0
13/CEN/109/AM03

Summary
Brief summary
Biomedical devices, such as artificial joints and pacemakers, are accepted and commonly used in medicine. While great progress in biomedical devices has been made for many other disorders, there is currently no device available to help with swallowing.. We have developed an implantable biomedical device (Swallow Expansion Device, SED) that assists with swallowing by allowing the individual to mechanically pull open the valve (upper esophageal sphincter, UES) at the top of the oesophagus, which will allow food and liquid to safely enter the oesophagus. This device is intended for use in people with severe swallow impairments who still wish to be able to eat something by mouth. Our hypothesis is that the SED can be safely implanted and integrated into the neck of a subject under local anaesthetic, and allow mechanical distraction of the UES to assist in swallow functions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89998 0
Dr Jacqueline Allen
Address 89998 0
Auckland Voice and Swallow Ltd
PO Box 99743
Newmarket
Auckland 1149
New Zealand
Country 89998 0
New Zealand
Phone 89998 0
+64 21897444
Fax 89998 0
Email 89998 0
[email protected]
Contact person for public queries
Name 89999 0
Dr Jacqueline Allen
Address 89999 0
Auckland Voice and Swallow Ltd
PO Box 99743
Newmarket
Auckland 1149
New Zealand
Country 89999 0
New Zealand
Phone 89999 0
+6421897444
Fax 89999 0
Email 89999 0
[email protected]
Contact person for scientific queries
Name 90000 0
Dr Jacqueline Allen
Address 90000 0
Auckland Voice and Swallow Ltd
PO Box 99743
Newmarket
Auckland 1149
New Zealand
Country 90000 0
New Zealand
Phone 90000 0
+64 21897444
Fax 90000 0
Email 90000 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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.