N/A
N=42
A Prospective, Single-center, Single-arm, Pivotal Trial of the Medtronic Hugo™ Robotic Assisted Surgery (RAS) System
Prostate Cancer · Cholelithiases · Cholecystitis · Gallbladder Polyp
Bottom Line
View on ClinicalTrials.gov: NCT05715827 ↗Enrolled (actual)
42
Serious AEs
10.0%
Results posted
Nov 2024
Primary outcome: Primary: Completion Rate — 20; 19 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- RAS prostatectomy and RAS cholecystectomy (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Medtronic - MITG
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Completion Rate |
20; 19 | — |
| SECONDARY Overall Complication Rate Through 30-day Post-surgery |
5; 3 | — |
| SECONDARY Major Complication Rate Through 30-day Post-surgery |
0; 2 | — |
| SECONDARY Readmission Rate Through 30-day Post-surgery |
1; 3 | — |
| SECONDARY Reoperation Rate Through 30-day Post-surgery |
0; 0 | — |
| SECONDARY Device Deficiency Rate |
10; 3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT05715827). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.