Janus II Feasibility
NCT06556693 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2025-10-29
Summary
The objectives of this study are to evaluate the feasibility of the remedē® Dual Channel System at implant and overnight sleep studies and to assess chronic safety.
Conditions
Interventions
- DEVICE
-
Dual Channel Stimulation
implant of dual channel stimulation device
Sponsors & Collaborators
-
Zoll Medical Corporation
lead INDUSTRY
Principal Investigators
-
Robin Germany, MD · ZOLL Respicardia
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 22 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-12
- Primary Completion
- 2028-04-30
- Completion
- 2034-12-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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