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New treatment option for Hypertension
Official title SPYRAL GEMINI Pilot Study
ClinicalTrials.gov ID: NCT06907147
What this study is testing
- What it's testing
- The purpose of the SPYRAL GEMINI Pilot Study is to evaluate that multi-organ denervation with the Gemini System is safe and provide evidence of blood pressure reduction when studied in an uncontrolled hypertensive population with and without high cardiovascular risk.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- All people (both cohorts):
- ≥18 and ≤80 years of age.
- Diagnosed with HTN and has a baseline office SBP ≥150 mmHg and \<180 mmHg and an office DBP ≥ 90 mmHg.
- 24-hour average SBP ≥140 mmHg and \<170 mmHg measured by ABPM at Baseline.
You likely can't join if
- Individual lacks appropriate renal artery OR common hepatic artery anatomy.
- Prior renal or hepatic denervation.
- History of NYHA Class III or IV heart failure within 6 months of screening visit.
- Stroke or transient ischemic attack (TIA) within 6 months of screening visit or any history of stroke leading to permanent disability.
- Documented Type 1 diabetes or use of insulin within 6 months.
- Secondary cause of hypertension.
See the full eligibility criteria
- All people (both cohorts):
- ≥18 and ≤80 years of age.
- Diagnosed with HTN and has a baseline office SBP ≥150 mmHg and \<180 mmHg and an office DBP ≥ 90 mmHg.
- 24-hour average SBP ≥140 mmHg and \<170 mmHg measured by ABPM at Baseline.
- Individual lacks appropriate renal artery OR common hepatic artery anatomy.
- Prior renal or hepatic denervation.
- History of NYHA Class III or IV heart failure within 6 months of screening visit.
- Stroke or transient ischemic attack (TIA) within 6 months of screening visit or any history of stroke leading to permanent disability.
- Documented Type 1 diabetes or use of insulin within 6 months.
- Secondary cause of hypertension.
- Documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement.
- Estimated glomerular filtration rate (eGFR) of \<40
- Pregnant, nursing or planning to become pregnant during the study.
- Primary pulmonary arterial hypertension.
- History or evidence of active / suspected chronic liver or biliary disease.
- Current or chronic pancreatitis.
The study team makes the final eligibility decision.
Where it's taking place
- Stanford, California, United States
- Orlando, Florida, United States
- Safety Harbor, Florida, United States
- Atlanta, Georgia, United States
- Boston, Massachusetts, United States
- Southfield, Michigan, United States
- Tupelo, Mississippi, United States
- Reno, Nevada, United States
- Camden, New Jersey, United States
- Chapel Hill, North Carolina, United States
- Dallas, Texas, United States
- Tyler, Texas, United States
- Perth, Australia
- Erlangen, Germany
- Homburg, Germany
- Athens, Greece
- Galway, Ireland
- Basel, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stanford, California, United States; Orlando, Florida, United States; Safety Harbor, Florida, United States; Atlanta, Georgia, United States; Boston, Massachusetts, United States; Southfield, Michigan, United States and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.