Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cholecystitis | — | UNRESOLVED | — |
| Cholelithiases | — | UNRESOLVED | — |
| Gallbladder Polyp | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RAS prostatectomy and RAS cholecystectomy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Robotic Assisted Surgery (RAS)
- description
- Robotic Assisted radical prostatectomy and cholecystectomy
- interventionNames
- Device: RAS prostatectomy and RAS cholecystectomy
Primary outcomes (1)
- measure
- Completion Rate
- timeFrame
- 24 hours
- description
- 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.
Secondary outcomes (5)
- measure
- Overall Complication Rate Through 30-day Post-surgery
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 22 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDKwon 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