NCT05715827

A Prospective, Single-center, Single-arm, Pivotal Trial of the Medtronic Hugo™ Robotic Assisted Surgery (RAS) System

A Prospective, Single-center, Single-arm, Pivotal Trial to Evaluate Safety and Efficacy of the Medtronic Hugo™ Robotic Assisted Surgery (RAS) System (Hello Hugo)

• Status: Completed
• Phase: —
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to test the safety and effectiveness of the Medtronic Hugo™ RAS System in patients undergoing a prostatectomy or a cholecystectomy. A minimum of 40 subjects will be enrolled at single site in Republic of Korea: 20 for prostatectomy and 20 for cholecystectomy. All participants will be followed for 30 days (±7 days) post-procedure.

Detailed description

This study is a prospective, single-center, single-arm, pivotal trial in 40 patients undergoing prostatectomy (N=20) or cholecystectomy (N=20) using the Medtronic Hugo™ RAS System. The objectives of this study are: * to confirm that the Medtronic Hugo™ RAS System performs as intended when used for prostatectomy or cholecystectomy * to assess the short-term safety outcome of the Medtronic Hugo™ RAS System when used for prostatectomy or cholecystectomy The Medtronic Hugo™ RAS System is intended to be used in this study for prostatectomy and cholecystectomy to be performed in subjects that meet the eligibility criteria. The subjects must be acceptable candidates for a fully robotic assisted procedure with the Medtronic Hugo™ RAS System, as determined by the principal investigator. Adult subjects indicated for a radical prostatectomy for clinically localized prostate cancer, or a cholecystectomy for cholelithiasis, cholecystitis, or gallbladder polyps will be included in this study. The study consists of following study visits: * Baseline: When a subject is consented, the principal investigator will review the subject's medical record and confirms if they meet all specified inclusion criteria and none of the exclusion criteria. * Surgical Procedure: The subject will arrive for admission to the hospital and prepped for surgery. The subject will receive a robotic assisted prostatectomy or cholecystectomy per indication. * Up to Discharge: The subject's condition will be closely monitored until discharge. Vital signs and laboratory test will be conducted. For prostatectomy subjects, pathological exam results will be also collected. * Post-Operative Follow-Up: Prostatectomy subjects will be followed at 7-day, 14-day (±3 days), and 30-day (±7 days) post-operative outpatient visits. Cholecystectomy subjects will be followed at 30-day (±7 days) post-operative outpatient visit.

Conditions

• Prostate Cancer
• Cholelithiases
• Cholecystitis
• Gallbladder Polyp

Interventions

Type	Name	Description
DEVICE	RAS prostatectomy and RAS cholecystectomy	There are two types of interventions in the study. Patients indicated for Robotic Assisted Surgery (RAS) for a prostatectomy will have the RAS surgery using the Medtronic Hugo RAS system. Patients indicated for Robotic Assisted Surgery (RAS) for a cholecystectomy will have the RAS surgery using the Medtronic Hugo RAS system.

Timeline

• Start date: 2023-02-12
• Primary completion: 2023-06-05
• Completion: 2023-07-10
• First posted: 2023-02-08
• Last updated: 2024-11-05
• Results posted: 2024-11-05

Locations

1 site across 1 country: South Korea