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Procedure

Extravsacular(Laparoscopic) Renal Denervation for High Blood Pressure (Hypertension)

N/A
Waitlist Available
Research Sponsored by DeepQure Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. Aged ≥22 and ≤80 years old at time of enrollment (consent).
2. Diagnosed with resistant hypertension.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to 1-, 3-, 6-, 12-, 24-, 36-months post-procedure
Awards & highlights

Summary

HQ-HTN-G01 is a prospective, multicenter, single arm, open label, early feasibility study to evaluate initial safety and device design concept of "HyperQureTM RDN System", laparoscopic renal denervation therapy, in patients with resistant hypertension on three(3) or more antihypertensive medications

Who is the study for?
This trial is for patients with resistant hypertension who are taking three or more blood pressure medications without success. It's not suitable for individuals with certain types of heart conditions, kidney diseases, or those who've had previous renal artery interventions.
What is being tested?
The study is testing the 'HyperQureTM RDN System', a new laparoscopic procedure aimed at lowering high blood pressure by disrupting nerves in the kidneys that contribute to hypertension.
What are the potential side effects?
Potential side effects may include pain at the incision site, bleeding, infection, and temporary increases in blood pressure post-procedure. Kidney function might also be affected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 1-, 3-, 6-, 12-, 24-, 36-months post-procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 1-, 3-, 6-, 12-, 24-, 36-months post-procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Decrease in 24-h Ambulatory Systolic Blood Pressure(ASBP)
• Incidence of major adverse events (MAE). Defined as a composite of the following events, through 1-month post-procedure
Secondary outcome measures
Change in 24-h ASBP
Change in 24-h Ambulatory Diastolic Blood Pressure(ADBP)
Change in Home Systolic Blood Pressure(SBP) and Diastolic Blood Pressure(DBP)
+6 more
Other outcome measures
Change in antihypertensive medication usage

Trial Design

1Treatment groups
Experimental Treatment
Group I: Extravsacular(Laparoscopic) Renal DenervationExperimental Treatment1 Intervention
Intervention: Device: HyperQureTM Renal Denervation (RDN) System: * HyperQureTM RDN Generator * HyperQureTM RDN Laparoscopic Instrument

Find a Location

Who is running the clinical trial?

DeepQure Inc.Lead Sponsor
1 Previous Clinical Trials
10 Total Patients Enrolled
~10 spots leftby Aug 2025
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