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Now Enrolling:
An early feasibility study of an investigational device for adults with resistant hypertension on 3 or more antihypertensive medications
Resistant hypertension requires persistent research.
Increasing research demonstrates that renal denervation (RDN), a minimally invasive procedure, is a promising new non-drug treatment method that can effectively control blood pressure.
Now enrolling: a study for adults with resistant hypertension on 3 or more antihypertensive medications
The purpose of this single-arm, open-label, early feasibility study is to evaluate the initial safety and device design concept of the HyperQureTM investigational RDN system in participants 22 to 80 years of age.
The results of this study will be used to:
Prove the concept of complete ablation by laparoscopic RDN
Develop a solid reference for a pivotal clinical investigation
About the HyperQureTM investigational RDN system
Uses a retroperitoneal laparoscopic approach
Designed to ablate the renal nerve from the exterior by wrapping around the renal artery, offering a more complete denervation than catheter-based devices
Learn more about HyperQureTM
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Study Site Locations
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Location
Travel reimbursement can be provided for patients traveling to the available sites
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Who can participate in this study?
Patients who meet the following criteria may qualify:
≥22 and ≤80 years of age at time of enrollment
Diagnosed with resistant hypertension
Currently on at least 3 antihypertensive medications of different classes, including a diuretic, for at least 4 weeks
This is not a full list of criteria. Click to see the full eligibility criteria.
Study Summary
Investigational Device:
HyperQureTM Renal Denervation (RDN) System:
HyperQureTM RDN Generator
HyperQureTM RDN Laparoscopic Instrument
Study Objective:
To assess initial safety and device design concept of laparoscopic RDN therapy using the HyperQureTM RDN System in patients diagnosed with resistant hypertension
Participant Details:
Adults 22 to 80 years of age with resistant hypertension on 3 or more antihypertensive medications
Sponsor
Enrollment Period:
Currently enrolling
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