Safety and Efficacy of Cryoablation in Management of Sialorrhea in Patients With Neurological Disorders

Study Overview
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Brief Summary
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To evaluate safety of cryoablation of submandibular glands in management of sialorrhea in neurologically impaired populations. Secondary Objective: To evaluate efficacy of cryoablation of submandibular glands in management of sialorrhea in neurologically impaired populations. Duration: Estimation for Recruitment: 12 months Estimation for Procedure/Trial: 1 visit with an overnight observation Estimation for Subject Follow Up: 7 days, 14 days, 28 days, 90 days, and 180 days, post ablation, with ultrasound of the bilateral submandibular glands at 28 days and 180 days post ablation Total Expected Duration for Clinical Trial: 2 years

Official Title
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Safety and Efficacy of Cryoablation in Management of Sialorrhea in Patients With Neurological Disorders.

Conditions
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Sialorrhea, Neurologic Disorder

Intervention / Treatment
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* Device: CRYOABLATION


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent and assent (as appropriate) obtained from the subject/caregiver who opted voluntarily to participate in the procedure Male or female 2 to 65 years of age Confirmed diagnosis of sialorrhea as documented in their medical record Clinically stable with no significant changes in health status in the 2 weeks before the ablation Patients diagnosed with cerebral palsy, or other neurological impairment documented in their medical record Exclusion Criteria: Open sores/ulcers on skin overlying the submandibular glands Contraindications to surgery/general anesthesia e.g; coagulopathies, life threatening arrhythmias Upper respiratory airway obstruction, e.g: severe dystonia History of previous local surgery Any congenital abnormalities that may preclude cryoablation, such as vascular abnormalities or atypical size/location Patients that have received salivary gland Botulinum toxin injections within the prior 3 months Subjects unlikely to complete the study as determined by the principle investigator

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CRYOABLATION ARM<br> | Device: CRYOABLATION<br>* The SeedNet® System induces freezing and thawing at the tip of the needle. These freezing and thawing processes are based on the Joule-Thomson effect. The unique technology of the SeedNet® System provides extremely rapid freeze and thaw operations. The system's software controls the flow of gases from the gas sources, through the manifold, to the needle and probe tips. The system can immediately switch from the freezing process to the thawing process, after which the needle can be released. This device is an FDA-cleared medical device. This IDE application is to allow for use of the commercially available device in a new clinical indication, namely cryoablation of the submandibular glands.<br>* Other names: SeedNet® System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate safety of cryoablation of submandibular glands in management of sialorrhea in neurologically impaired populations. | 1. Safety Parameters: Major adverse events will be submitted to the Agency and be reviewed by the medical monitor. In case unexpected events should occur we will evaluate and report them. 2 Methods for Analyzing Safety Parameters: Prior to the enrollment of the first research subject, the study sponsor will organize and conduct an initial meeting for the medical monitor. The medical monitor will review AE logs, deviation logs, procedural details, call logs, phone scripts, study progress notes, patient medical charts, and completed questionnaires, every 5 patients, or quarterly, whichever takes place first. The sponsor-investigator will oversee the conduct of the medical monitor. Directives provided by the medical monitor will be reported accordingly and as necessary to the Food and Drug Administration and the IRB. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate efficacy of cryoablation of submandibular glands in management of sialorrhea in neurologically impaired populations. | Efficacy Parameters: Efficacy is defined as reduced score on the Drooling Impact Scale (range: 10-100) at baseline, 1 and 6 months interval with-in subject self-assessment. Methods for Analyzing Efficacy Parameters: We will qualitatively assess the impact of drooling on patients, their families, and/or caretakers, at baseline, then twice post procedurally, using a questionnaire. The questionnaire known as the Drooling Impact Scale 'DIS' has been devised to evaluate longitudinal changes in children with neurological disorders, and quantify short- to medium-term treatment benefits of saliva-control interventions. | 2 years |