NCT06445504

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

A Prospective, Multi-center, Single-arm Study of the Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Inguinal and Ventral Hernia Repair Surgery (Enable Hernia)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 193 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Inguinal Hernia
• Ventral Hernia

Interventions

Type	Name	Description
DEVICE	Robotic-Assisted Surgery (RAS) Hernia Repair Surgery	Patients indicated for Robotic-Assisted Surgery (RAS) for ventral and inguinal hernia repair will have the RAS surgery using the Medtronic Hugo RAS system

Timeline

• Start date: 2024-04-08
• Primary completion: 2025-03-19
• Completion: 2027-03-15
• First posted: 2024-06-06
• Last updated: 2025-04-16

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study