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

NCT05715827 | Completed Results

• 1 other identifier: MDT21028
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer; Cholelithiases; Cholecystitis; Gallbladder Polyp

Outcome Measures

Primary Outcomes (1)

• Completion Rate

  The primary endpoint of this study is the completion rate, which is defined as a proportion of subjects who completed the surgery without conversion due to system serious malfunction, and without any major complications within 24-hour post-surgery.

  24 hours

Secondary Outcomes (5)

• Overall Complication Rate Through 30-day Post-surgery

  30 days

• Major Complication Rate Through 30-day Post-surgery

  30 days

• Readmission Rate Through 30-day Post-surgery

  30 days

• Reoperation Rate Through 30-day Post-surgery

  30 days

• Device Deficiency Rate

  Peri-operative

Study Arms (1)

Robotic Assisted Surgery (RAS)

EXPERIMENTAL

Robotic Assisted radical prostatectomy and cholecystectomy

Device: RAS prostatectomy and RAS cholecystectomy

Interventions

RAS prostatectomy and RAS cholecystectomy DEVICE

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.

Robotic Assisted Surgery (RAS)

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patient with a considerable risk for laparoscopic surgery (e.g., severe cardiopulmonary diseases which contraindicated to general anesthesia, uncontrolled coagulopathy, etc.)
• Patients requiring urgent surgery
• Pregnant or lactating women
• 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
• Previous abdominal surgery (open or laparoscopic) within 2 years before enrollment
• Concurrent participation in another clinical study that may confound study results
• Patient has a condition that could compromise study compliance (e.g., mentally incompetent, alcohol or drug abuse) as determined by the investigator
• Subjects who are considered unsuitable to conduct the trial as determined by the investigator

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

Location

Related Publications (1)

• Kwon W, Jang JY, Jeong CW, Anselme S, Pradella F, Woods J. Cholecystectomy with the Hugo robotic-assisted surgery system: the first general surgery clinical study in Korea. Surg Endosc. 2025 Jan;39(1):171-179. doi: 10.1007/s00464-024-11334-4. Epub 2024 Oct 28.

  PMID: 39466427 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Cholelithiasis; Cholecystitis

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases

Results Point of Contact

• Title: Yewon Lee
• Organization: Medtronic

yewon.lee@medtronic.com

1031132023

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 8, 2023
• Study Start: February 12, 2023
• Primary Completion: June 5, 2023
• Study Completion: July 10, 2023
• Last Updated: November 5, 2024
• Results First Posted: November 5, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)