Trial Review

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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
Scientific title
XII Medical Hypoglossal Nerve Stimulation Evaluation in patients undergoing neck dissection
A Technical Feasibility Study
Secondary ID [1] 309912 0
XII-01 Study
Universal Trial Number (UTN)
U1111-1293-8568
Trial acronym
XII-01 Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea (OSA) 330378 0
Condition category
Condition code
Respiratory 327218 327218 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 326341 0
Treatment: Devices
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335104 0
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.
Timepoint [1] 335104 0
Technical feasibility will be evaluated during the procedure.
Secondary outcome [1] 422997 0
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.
Timepoint [1] 422997 0
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.

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This is an early phase study that is not statistically powered.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
5/09/2023
Actual
12/10/2023
Date of last participant enrolment
Anticipated
1/03/2024
Actual
18/10/2023
Date of last data collection
Anticipated
31/03/2024
Actual
Sample size
Target
10
Accrual to date
Final
3
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 24927 0
Wollongong Hospital - Wollongong
Recruitment hospital [2] 24928 0
Chris O’Brien Lifehouse - Camperdown
Recruitment postcode(s) [1] 40580 0
2050 - Camperdown
Recruitment postcode(s) [2] 40579 0
2500 - Wollongong

Funding & Sponsors
Funding source category [1] 314093 0
Commercial sector/Industry
Name [1] 314093 0
XII Medical, Inc.
Country [1] 314093 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
XII Medical, Inc.
Address
32980 Alvarado Niles Road, Suite 856
Union City, California, 95487
USA
Country
United States of America
Secondary sponsor category [1] 316009 0
Commercial sector/Industry
Name [1] 316009 0
Rozenberg & Co Pty Ltd
Address [1] 316009 0
13A Roslyn Gardens, Elizabeth Bay, Sydney, 2011 NSW, Australia
Country [1] 316009 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313233 0
Bellberry Ltd
Ethics committee address [1] 313233 0
Bellberry Office (SA)
123 Glen Osmond Road Eastwood Adelaide
South Australia 5063
Ethics committee country [1] 313233 0
Australia
Date submitted for ethics approval [1] 313233 0
03/06/2023
Approval date [1] 313233 0
16/06/2023
Ethics approval number [1] 313233 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127430 0
Prof Stuart MacKay FRACS
Address 127430 0
Wollongong Hospital, IllawarraLoftus StreetWollongong NSW 2500
Country 127430 0
Australia
Phone 127430 0
+61 428176990
Fax 127430 0
Email 127430 0
sgmackay@ozemail.com.au
Contact person for public queries
Name 127431 0
Ms Jennifer Murray Hebert
Address 127431 0
XII Medical, Inc.32980 Alvarado Niles Road, Suite 856Union City, California, 95487 USA
Country 127431 0
United States of America
Phone 127431 0
+1 650 400 1837
Fax 127431 0
Email 127431 0
jennifer.mh@xiimedical.com
Contact person for scientific queries
Name 127432 0
Ms Jennifer Murray Hebert
Address 127432 0
XII Medical, Inc.32980 Alvarado Niles Road, Suite 856Union City, California, 95487 USA
Country 127432 0
United States of America
Phone 127432 0
+1 650 400 1837
Fax 127432 0
Email 127432 0
jennifer.mh@xiimedical.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.


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.