NCT05696444

Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO)

A Prospective, Multi-center, Single-arm Study of the Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety and performance of the Medtronic Hugo™ RAS System when used for urologic RAS procedures.

Detailed description

A prospective, multicenter, single-arm pivotal study in subjects undergoing a urologic RAS procedure using the Medtronic Hugo™ RAS System. Subjects without an oncologic indication will be followed for 30 days post-procedure. Oncologic subjects will be followed annually through 5 years. The study will be conducted in up to 6 investigative sites in the United States of America (USA).

Conditions

• Bladder Cancer
• Prostate Cancer
• Kidney Cancer
• Pelvic Tumor
• Interstitial Cystitis
• Congenital Abnormalities
• End Stage Renal Disease
• Renal Tumor
• Kidney Injury

Interventions

Type	Name	Description
DEVICE	RAS Prostatectomy	Subjects indicated for Robotic Assisted Surgery (RAS) for prostatectomy will have RAS surgery using the Medtronic Hugo RAS system.
DEVICE	RAS Cystectomy	Subjects indicated for Robotic Assisted Surgery (RAS) for cystectomy will have RAS surgery using the Medtronic Hugo RAS system.
DEVICE	RAS Nephrectomy	Subjects indicated for Robotic Assisted Surgery (RAS) for nephrectomy (Radical/Partial) will have RAS surgery using the Medtronic Hugo RAS system.

Timeline

• Start date: 2022-12-14
• Primary completion: 2024-10-10
• Completion: 2030-01-31
• First posted: 2023-01-25
• Last updated: 2025-11-25
• Results posted: 2025-11-25

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study