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

Primary Purpose

Sialorrhea, Neurologic Disorder

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CRYOABLATION
Sponsored by
Dean Nakamoto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sialorrhea

Eligibility Criteria

2 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Written informed consent and assent (as appropriate) obtained from the subject/caregiver who opted voluntarily to participate in the procedure
  2. Male or female 2 to 65 years of age
  3. Confirmed diagnosis of sialorrhea as documented in their medical record
  4. Clinically stable with no significant changes in health status in the 2 weeks before the ablation
  5. Patients diagnosed with cerebral palsy, or other neurological impairment documented in their medical record

Exclusion Criteria:

  1. Open sores/ulcers on skin overlying the submandibular glands
  2. Contraindications to surgery/general anesthesia e.g; coagulopathies, life threatening arrhythmias
  3. Upper respiratory airway obstruction, e.g: severe dystonia
  4. History of previous local surgery
  5. Any congenital abnormalities that may preclude cryoablation, such as vascular abnormalities or atypical size/location
  6. Patients that have received salivary gland Botulinum toxin injections within the prior 3 months
  7. Subjects unlikely to complete the study as determined by the principle investigator

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    CRYOABLATION ARM

    Arm Description

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    February 23, 2018
    Last Updated
    November 26, 2021
    Sponsor
    Dean Nakamoto
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03704168
    Brief Title
    Safety and Efficacy of Cryoablation in Management of Sialorrhea in Patients With Neurological Disorders
    Acronym
    SECAMS
    Official Title
    Safety and Efficacy of Cryoablation in Management of Sialorrhea in Patients With Neurological Disorders.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    The study was never launched.
    Study Start Date
    May 1, 2019 (Anticipated)
    Primary Completion Date
    April 30, 2021 (Anticipated)
    Study Completion Date
    April 30, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Dean Nakamoto

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sialorrhea, Neurologic Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CRYOABLATION ARM
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    CRYOABLATION
    Other Intervention Name(s)
    SeedNet® System
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    To evaluate safety of cryoablation of submandibular glands in management of sialorrhea in neurologically impaired populations.
    Description
    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.
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    To evaluate efficacy of cryoablation of submandibular glands in management of sialorrhea in neurologically impaired populations.
    Description
    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.
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

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