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Withdrawn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
About this trial
This is an interventional treatment trial for Sialorrhea
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
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
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
We'll reach out to this number within 24 hrs