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SPYRAL GEMINI Pilot Study

Study acronym: SPYRAL GEMINI
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 16 to 18v13
  2. Trial sites expanded: 13 → 16 locationsv12
  3. Eligibility criteria expanded, about 27 wordsv11 See this version in full on ClinicalTrials.gov ↗
  4. Study sites: 12 to 13v10
  5. Study sites: 10 to 12v9
Show 7 earlier versionsHide 7 earlier versions
  1. Study sites: 9 to 10v8
  2. Study sites: 8 to 9v7
  3. Re-verified, no change to tracked fieldsv6
  4. Study sites: 7 to 8v5
  5. Study sites: 6 to 7v4
  6. Study sites: 4 to 6v3
  7. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 4 · Start date changed from estimate of Apr 3, 2025 to May 1, 2025v2 Show 2 more changesShow less
    • Study sites: 0 to 4
    • Start date changed from estimate of Apr 3, 2025 to May 1, 2025
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Medtronic Vascular
11 trials monitored
See all monitored trials
Diabetes
4,286 trials monitored
See 187 trials at risk
Heart Disease
2,136 trials monitored
See 109 trials at risk
Hypertension
1,795 trials monitored
See 85 trials at risk
and 1 more disease
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.
Trial Details
NCT Number NCT06907147
Lead Sponsor Medtronic Vascular
Conditions Hypertension, Vascular Diseases, Cardiovascular Diseases, Chronic Kidney Diseases, Diabetes Mellitus
Enrollment 175 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov