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Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
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Trial registered on ANZCTR
Registration number
ACTRN12623000942651
Ethics application status
Approved
Date submitted
15/06/2023
Date registered
1/09/2023
Date last updated
30/11/2023
Date data sharing statement initially provided
1/09/2023
Date results information initially provided
30/11/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
XII Medical Hypoglossal Nerve Stimulation Evaluation
A Technical Feasibility Study
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Scientific title
XII Medical Hypoglossal Nerve Stimulation Evaluation in patients undergoing neck dissection
A Technical Feasibility Study
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Secondary ID [1]
309912
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XII-01 Study
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Universal Trial Number (UTN)
U1111-1293-8568
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Trial acronym
XII-01 Study
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea (OSA)
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Condition category
Condition code
Respiratory
327218
327218
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0
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Sleep apnoea
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The XII Medical Hypoglossal Nerve (HGN) stimulation system is a neurostimulator designed to stimulate the HGN to induce tongue motion. A skilled head and neck surgeon will administer the the stimulation as an add-on to an already planned surgery where the target location is already exposed. The temporary stimulation will be applied for approximately 5 to 15 minutes in total with the investigational portion of the procedure adding approximately 45 minutes. The neurostimulator will be removed prior to completion of the planned neck surgery. There are no further dosage, consultations, or other need for monitoring adherence to the intervention. The participant's medical records will be reviewed at 14 days.
Stimulation Settings:
Pulse Amplitude: 0.1mA to 7.5mA.
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Intervention code [1]
326341
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Treatment: Devices
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Comparator / control treatment
No control group.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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The primary objective of this study is to evaluate safety and technical feasibility of the XII Medical Hypoglossal Nerve Stimulation (HGNS) System in a controlled clinical setting as demonstrated through tongue motion. Assessment of tongue motion will be provided by the head and neck surgeon.
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Assessment method [1]
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Timepoint [1]
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Technical feasibility will be evaluated during the procedure.
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Secondary outcome [1]
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Safety will be evaluated as freedom from device or procedure related AEs. A cranial nerve XII exam will be performed at baseline and again post procedure. The cranial nerve exam will be performed by a healthcare professional qualified to administer this exam.
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Assessment method [1]
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Timepoint [1]
422997
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Participants will undergo an evaluation immediately post procedure and again at 12 hours following the surgery. A review of adverse events will also be performed at 14 days post procedure. If there are no potential AEs related to the study device or procedure that are ongoing, the participant will be exited from the study.
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Eligibility
Key inclusion criteria
The patient has consented to and is scheduled to undergo the planned non-study related neck surgery (the already planned surgery).
The patient is at least 18 years of age at the time of consent.
The patient has been informed of the nature of the trial, has agreed to its provisions, and has provided written informed consent as approved by the EC of the respective clinical site.
The patient has been evaluated and approved for participation by the Investigator.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
The patient is pregnant or nursing (breastfeeding).
The patient has a known history of untreated or unstable psychiatric or other mental health concern or disorder that would impact the patient’s ability to provide informed consent.
The patient is under incarceration.
The patient is actively enrolled in another clinical trial that may compromise study results.
The patient is unwilling, unable to complete, or unable to understand protocol requirements (e.g., mental health issues; visual, auditory, or learning impairment; or who are unable to comprehend English).
The patient has a history of radiation at the target treatment area.
The patient has an active implantable device.
The patient has a BMI >35.
The patient has a history of allergic or hypersensitive reaction to materials used during the surgery and/or to patient contacting components of the investigational device..
The patient has pre-existing target nerve weakness or is undergoing a related procedure which carries risk of injury to the target nerve.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
This is an early phase study that is not statistically powered.
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
5/09/2023
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Actual
12/10/2023
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Date of last participant enrolment
Anticipated
1/03/2024
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Actual
18/10/2023
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Date of last data collection
Anticipated
31/03/2024
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Actual
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Sample size
Target
10
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Accrual to date
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Final
3
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Wollongong Hospital - Wollongong
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Recruitment hospital [2]
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Chris O’Brien Lifehouse - Camperdown
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Recruitment postcode(s) [1]
40579
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2500 - Wollongong
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Recruitment postcode(s) [2]
40580
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2050 - Camperdown
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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XII Medical, Inc.
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Address [1]
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32980 Alvarado Niles Road, Suite 856
Union City, California, 95487
USA
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Country [1]
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United States of America
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Primary sponsor type
Commercial sector/Industry
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Name
XII Medical, Inc.
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Address
32980 Alvarado Niles Road, Suite 856
Union City, California, 95487
USA
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Country
United States of America
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Secondary sponsor category [1]
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Commercial sector/Industry
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Name [1]
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Rozenberg & Co Pty Ltd
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Address [1]
316009
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13A Roslyn Gardens, Elizabeth Bay, Sydney, 2011 NSW, Australia
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Country [1]
316009
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Bellberry Ltd
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Ethics committee address [1]
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Bellberry Office (SA)
123 Glen Osmond Road Eastwood Adelaide
South Australia 5063
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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03/06/2023
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Approval date [1]
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16/06/2023
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Ethics approval number [1]
313233
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Summary
Brief summary
The XII-01 Study is a prospective, non-randomised, multi-centre technical feasibility study that is designed to evaluate initial safety and feasibility of the investigational device. This clinical investigation is the first critical step utilizing the investigational device in a series of planned studies. The main objective of this study is temporary placement of the investigational device to confirm its ability to achieve nerve stimulation. Researchers hypothesize that this system will achieve nerve stimulation representative of stimulation that is used to treat patients with OSA.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Stuart MacKay FRACS
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Address
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Wollongong Hospital, IllawarraLoftus StreetWollongong NSW 2500
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Country
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Australia
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Phone
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+61 428176990
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Ms Jennifer Murray Hebert
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Address
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XII Medical, Inc.32980 Alvarado Niles Road, Suite 856Union City, California, 95487 USA
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Country
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United States of America
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Phone
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+1 650 400 1837
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Ms Jennifer Murray Hebert
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Address
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XII Medical, Inc.32980 Alvarado Niles Road, Suite 856Union City, California, 95487 USA
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Country
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United States of America
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Phone
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+1 650 400 1837
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
The data will be resulting from a maximum of up to 10 subjects. Additional analyses of the data are not anticipated. The results of this study are binary meaning either tongue motion is achieved or it is not.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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