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

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

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

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