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

Dean Nakamoto

Status: Withdrawn

Conditions: Sialorrhea; Neurologic Disorder

Treatments: Device: CRYOABLATION

Study type: Interventional

Funder types: Other

Identifiers

NCT03704168

SECAMS

Details and patient eligibility

About

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

Sex: All

Ages: 2 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

CRYOABLATION ARM

Experimental group

Treatment:

Device: CRYOABLATION