None listed
Conditions
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.
Interventions
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 pr
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.
Sponsors
XII Medical, Inc.
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed