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)

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.

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.

Inclusion Criteria:

1. Adult subjects (22 years old or greater) who are willing to participate and provide informed consent

2. Subjects indicated for a radical prostatectomy or a cholecystectomy

   • Prostatectomy: Male patients requiring radical prostatectomy for clinically localized prostate cancer (* Clinically localized prostate cancer is defined as following: biopsy-proven prostate adenocarcinoma, clinical staged as T1-T2N0M0 upon standard imaging findings such as bone scan, MRI, or CT)
   • Cholecystectomy: Patients requiring cholecystectomy for cholelithiasis, cholecystitis, or gallbladder polyps (* For gallbladder polyps, only followings will be considered: gallbladder polyps ≥10 mm, enlarging polyps, or symptomatic gallbladder polyps)

Exclusion Criteria:

1. Patient with a considerable risk for laparoscopic surgery (e.g., severe cardiopulmonary diseases which contraindicated to general anesthesia, uncontrolled coagulopathy, etc.)

2. Patients requiring urgent surgery

3. Pregnant or lactating women

4. Patients with either of followings:

   • Prostatectomy: Metastatic prostate cancer or estimated life expectancy less than 10 years
   • Cholecystectomy: Severe liver cirrhosis (Child-Pugh class C) with portal hypertension, suspicion of gallbladder cancer

5. Previous abdominal surgery (open or laparoscopic) within 2 years before enrollment

6. Concurrent participation in another clinical study that may confound study results

7. Patient has a condition that could compromise study compliance (e.g., mentally incompetent, alcohol or drug abuse) as determined by the investigator

8. Subjects who are considered unsuitable to conduct the trial as determined by the investigator