SialorrheaSECAMSNCT03704168
Safety and Efficacy of Cryoablation in Management of Sialorrhea in Patients With Neurological Disorders
A study testing CRYOABLATION in people with Sialorrhea and Neurologic Disorder, run by Dean Nakamoto.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 65 years
- Conditions the study is for
- Sialorrhea, Neurologic Disorder
- What is being tested?
- CRYOABLATION
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2019to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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
- Conditions
- Sialorrhea, Neurologic Disorder
- Being tested
- CRYOABLATION
- Medical subject headings
- Sialorrhea, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRYOABLATIONDevice
Also called SeedNet® System
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.
| Study group | Role | What they receive |
|---|---|---|
| CRYOABLATION ARM | Experimental | Not described Receives: Device: CRYOABLATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate safety of cryoablation of submandibular glands in management of sialorrhea in neurologically impaired populations.
- 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.
Measured: 2 years
Secondary outcomes (1)
To evaluate efficacy of cryoablation of submandibular glands in management of sialorrhea in neurologically impaired populations.
- 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.
- 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2018
- Study start1 May 2019 (estimated)
- Primary completion30 Apr 2021 (estimated)
- Study completion30 Apr 2021 (estimated)
Why it stopped: The study was never launched.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SialorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dean Nakamoto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dean Nakamoto, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03704168
- Sponsor's protocol ID
- SECAMS
- Acronym
- SECAMS
- Status last verified
- Nov 2021
- First submitted
- 23 Feb 2018
- Last updated
- 29 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Cryoablation in Management of Sialorrhea in Patients With Neurological Disorders.
- ClinicalTrials.gov ID
- NCT03704168
- Acronym / sponsor ID
- SECAMS / SECAMS
- Conditions
- Sialorrhea, Neurologic Disorder
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was never launched.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dean NakamotoUniversity, hospital or other
- Study start
- 1 May 2019 (estimated)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 12 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRYOABLATION ARM | Experimental | Device: CRYOABLATION |
Who may qualify
- Ages
- 2 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRYOABLATIONAlso: SeedNet® SystemThe 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. | Device | CRYOABLATION ARM |
Primary outcome
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.
1 secondary outcome
To evaluate efficacy of cryoablation of submandibular glands in management of sialorrhea in neurologically impaired populations.
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing CRYOABLATION in people with Sialorrhea and Neurologic Disorder, run by Dean Nakamoto.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate safety of cryoablation of submandibular glands in management of sialorrhea in neurologically impaired populations. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2021.