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โ† Trials
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Janus II Feasibility

RecruitingNAAges 22 Years - anyAllZoll Medical Corporation
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In plain words

What the trial is, and whether it could suit you

The objectives of this study are to evaluate the feasibility of the remedฤ“ยฎ Dual Channel System at implant and overnight sleep studies and to assess chronic safety.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Severe sleep disordered breathing * Expected to tolerate study procedures * No heart failure or medically stable heart failure Exclusion Criteria: * Currently implanted with a neurostimulator to treat sleep disordered breathing without sponsor approval * History of severe COPD or pulmonary arterial hypertension * Current or previous history of nerve injury or palsy * Prior cervical surgeries or radiation treatment to head region * Known need for an MRI * History of psychosis or severe bipolar disorder * Active Infection or sepsis within 30 days of enrollment * Currently on kidney dialysis or significantly reduced kidney function * Pacemaker dependance * New defibrillator or any implantable device or device generator changeout within 30 days prior to study implant or anticipated within the first 12 months * Other conditions or anticipated surgical procedure expected to affect ability to complete study procedures * Allergy to contrast dye unless can be prophylactically treated * Known pregnancy or planning to become pregnant
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What it tests

  • Dual Channel Stimulation
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Where

4 sites
The Insomnia and Sleep Institute of Arizona LLC
Scottsdale, United States
The University of Michigan Health-West
Wyoming, United States
The Ohio State University
Columbus, United States
Houston Methodist Institute
Houston, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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