XII Medical Hypoglossal Nerve Stimulation EvaluationA Technical Feasibility Study

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea (OSA); Respiratory - Sleep apnoea

• Registration Number: ACTRN12623000942651
• Lead Sponsor: XII Medical, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-01
• Study Completion: 2024-03-31
• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 3

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified