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

NCT03704168 | Withdrawn

• 1 other identifier: SECAMS
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Sialorrhea; Neurologic Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To evaluate efficacy of cryoablation of submandibular glands in management of sialorrhea in neurologically impaired populations.

  2 years

Study Arms (1)

CRYOABLATION ARM

EXPERIMENTAL

Device: CRYOABLATION

Interventions

CRYOABLATION DEVICE

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.

Also known as: SeedNet® System

CRYOABLATION ARM

Eligibility Criteria

• Age: 2 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dean Nakamoto: lead

MeSH Terms

Conditions

Sialorrhea; Nervous System Diseases

Interventions

Cryosurgery

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Division Chief, Abdominal Imaging - UH Cleveland Medical Center

Study Record Dates

• First Submitted: February 23, 2018
• First Posted: October 12, 2018
• Study Start: May 1, 2019
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: November 29, 2021

Record last verified: 2021-11