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Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Hernia Surgery (Enable Hernia Repair)

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Results first posted: May 4, 2026
    • Primary endpoints revised (2)
    • Enrollment target: 193 to 206
    • Secondary endpoints revised (7)
    v8
  2. Primary endpoints revised (2)
    • Study completion date: Mar 15, 2027 to Mar 2027
    • Secondary endpoints revised (7)
    v7
  3. Lead sponsor: [Redacted] to Medtronic - MITGv6 Show 5 more changesShow less
    • Trial status: Withheld to Active, Not Recruiting
    • Primary completion date: Mar 19, 2025
    • Study completion date: Mar 15, 2027
    • Start date: Apr 8, 2024
    • Study title revised
  4. 4 versions Re-verified since Jul 30, 2024, no change to tracked fieldsv2-v5
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A prospective, multicenter, single-arm pivotal study will be performed with 192 subjects enrolled to have an inguinal or ventral robotic hernia repair procedure using the Medtronic Hugo™ RAS system. Subjects will be followed through two years. This study will be conducted using up to ten investigative sites in the United States (US).
Trial Details
NCT Number NCT06445504
Lead Sponsor Medtronic - MITG
Conditions
(from sponsor)		 Inguinal Hernia, Ventral Hernia
Related terms Hernia, Inguinal, Hernia, Ventral
Enrollment 206 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov