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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRYOABLATION ARM | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRYOABLATION | Device | The SeedNetĀ® 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 SeedNetĀ® 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate efficacy of cryoablation of submandibular glands in management of sialorrhea in neurologically impaired populations. |
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. |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D012798 | Sialorrhea |
| D009422 | Nervous System Diseases |
| ID | Term |
|---|---|
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D003452 | Cryosurgery |
| ID | Term |
|---|---|
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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| 2 years |