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

• ClinicalTrials.gov Identifier: NCT03704168
• Recruitment Status: Withdrawn
• First Posted: October 12, 2018
• Last Update Posted: November 29, 2021
• Sponsor: Dean Nakamoto
• Information provided by (Responsible Party): Dean Nakamoto, University Hospitals Cleveland Medical Center

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

Condition or disease	Intervention/treatment	Phase
Sialorrhea; Neurologic Disorder	Device: CRYOABLATION	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Safety and Efficacy of Cryoablation in Management of Sialorrhea in Patients With Neurological Disorders.
• Estimated Study Start Date: May 1, 2019
• Estimated Primary Completion Date: April 30, 2021
• Estimated Study Completion Date: April 30, 2021

Arms and Interventions

Arm

Intervention/treatment

Experimental: CRYOABLATION ARM

Device: CRYOABLATION; 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.; Other Name: SeedNet® System

Outcome Measures

Primary Outcome Measures :

1. To evaluate safety of cryoablation of submandibular glands in management of sialorrhea in neurologically impaired populations. [ Time Frame: 2 years ]

   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 :

1. To evaluate efficacy of cryoablation of submandibular glands in management of sialorrhea in neurologically impaired populations. [ Time Frame: 2 years ]

   1. 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.

   2. 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.

Eligibility Criteria

• Ages Eligible for Study: 2 Years to 65 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Dean Nakamoto, Division Chief, Abdominal Imaging - UH Cleveland Medical Center, University Hospitals Cleveland Medical Center
• ClinicalTrials.gov Identifier: NCT03704168
• Other Study ID Numbers: SECAMS
• First Posted: October 12, 2018
• Last Update Posted: November 29, 2021
• Last Verified: November 2021

• 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

Additional relevant MeSH terms:

Sialorrhea; Nervous System Diseases; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases