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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic Assisted Surgery (RAS) | Experimental | Robotic Assisted radical prostatectomy and cholecystectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Complication Rate Through 30-day Post-surgery | A proportion of subjects with any post-operative complication within 30-days post-surgery using the investigational device | 30 days |
| Major Complication Rate Through 30-day Post-surgery |
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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
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:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | Jongno-gu | 03080 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39466427 | Derived | 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. |
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After enrollment, two Cholecystectomy subjects exited the study before surgery due to a surgeon's decision and a console communication error.
These two subjects did not undergo a procedure with the Hugo™ RAS System and were treated with laparoscopy as Standard-of-care treatment.
The recruitment period was from February 12, 2023, to May 7th, 2023.
Subjects were recruited at Seoul National University Hospital, a major hospital in Seoul, Korea.
Enrollment involved 42 subjects, with 20 subjects indicated for robotic-assisted Prostatectomy and 22 subjects indicated for robotic-assisted Cholecystectomy.
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| ID | Title | Description |
|---|---|---|
| FG000 | Robotic Assisted Radical Prostatectomy | Robotic-assisted Radical Prostatectomy Patients indicated for Robotic Assisted Surgery (RAS) for a Prostatectomy will have the RAS surgery using the Medtronic Hugo RAS system. |
| FG001 | Robotic-assisted Cholecystectomy | Robotic-assisted Cholecystectomy Patients indicated for Robotic Assisted Surgery (RAS) for a Cholecystectomy will have the RAS surgery using the Medtronic Hugo RAS system. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The full Analysis Set (FAS) used to evaluate the primary and secondary endpoints was defined as all enrolled subjects in whom a Hugo™ RAS procedure began. Therefore, the 2 cholecystectomy subjects who did not undergo a procedure with the Hugo™ RAS System and exited the study before surgery were excluded from the FAS.
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| ID | Title | Description |
|---|---|---|
| BG000 | Robotic Assisted Prostatectomy | The study population will consist of patients 22 years of age or older indicated for a robotic assisted prostatectomy with Hugo™ RAS. |
| BG001 | Robotic Assisted Cholecystectomy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | For the analysis, we considered the Full Analysis Set (FAS), defined as all enrolled subjects who began the Hugo™ RAS procedure (first skin incision). Subjects who consented but did not reach the first incision were excluded. Those converted to open or conventional surgery, not due to the Hugo™ RAS System, were included in the safety and descriptive analyses but excluded from the primary endpoint analysis. | Posted | Count of Participants | Participants | 24 hours |
|
Adverse event data were collected throughout the study duration, including the baseline period, surgical procedure, up to hospital discharge, and during the follow-up visits, which extended up to 30 days post-surgery.
In this study, an adverse event (AE) is defined as any untoward medical occurrence in a subject, which does not necessarily have a causal relationship with the study device. A serious adverse event (SAE) is any AE that results in death, is life-threatening, requires hospitalization, results in disability or permanent damage, or necessitates intervention to prevent permanent impairment or damage.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RAS Prostatectomy | 20 subjects who were indicated for robotic-assisted Prostatectomy received a surgery with the Hugo RAS System. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia | General disorders | MedDRA version 26.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yewon Lee | Medtronic | 1031132023 | yewon.lee@medtronic.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 3, 2023 | Aug 11, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 15, 2023 | Aug 11, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D002769 | Cholelithiasis |
| D002764 | Cholecystitis |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
This measure reports the proportion of subjects with post-operative complications classified as Grade 3 or higher by the Clavien-Dindo system within 30 days post-surgery. The Clavien-Dindo system classifies post-operative complications from Grade 1 (minor) to Grade 5 (death).
Grade 1: Minor deviation, no intervention. Grade 2: Requires medication or transfusion. Grade 3: Requires surgical, endoscopic, or radiological intervention. Grade 4: Life-threatening, requires ICU. Grade 5: Death. Higher grades indicate worse outcomes, with Grade 3 or higher classified as "major complications."
| 30 days |
| Readmission Rate Through 30-day Post-surgery | A proportion of subjects hospitalized within 30 days post-surgery | 30 days |
| Reoperation Rate Through 30-day Post-surgery | A proportion of subjects go through reoperation for the same indication within 30 days post-surgery | 30 days |
| Device Deficiency Rate | A proportion of subjects with any device deficiency (DD) during robotic assisted surgery using the investigational device | Peri-operative |
The study population will consist of patients 22 years of age or older indicated for a robotic assisted cholecystectomy with Hugo™ RAS.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Median | Inter-Quartile Range | kg/m2 |
|
| OG001 | RAS Cholecystectomy | 20 subjects indicated for robotic-assisted Cholecystectomy received surgery with the Hugo RAS system |
|
|
|
| Secondary | Overall Complication Rate Through 30-day Post-surgery | A proportion of subjects with any post-operative complication within 30-days post-surgery using the investigational device | subjects who were indicated for robotic-assisted Prostatectomy and Cholecystectomy who went under procedure with Hugo RAS System | Posted | Count of Participants | Participants | 30 days |
|
|
|
|
| Secondary | Major Complication Rate Through 30-day Post-surgery | This measure reports the proportion of subjects with post-operative complications classified as Grade 3 or higher by the Clavien-Dindo system within 30 days post-surgery. The Clavien-Dindo system classifies post-operative complications from Grade 1 (minor) to Grade 5 (death). Grade 1: Minor deviation, no intervention. Grade 2: Requires medication or transfusion. Grade 3: Requires surgical, endoscopic, or radiological intervention. Grade 4: Life-threatening, requires ICU. Grade 5: Death. Higher grades indicate worse outcomes, with Grade 3 or higher classified as "major complications." | subjects indicated for robotic-assisted Cholecystectomy received surgery with Hugo RAS System | Posted | Count of Participants | Participants | 30 days |
|
|
|
|
| Secondary | Readmission Rate Through 30-day Post-surgery | A proportion of subjects hospitalized within 30 days post-surgery | subjects who were indicated for robotic-assisted Prostatectomy and Cholecystectomy underwent the procedure with Hugo RAS system | Posted | Count of Participants | Participants | 30 days |
|
|
|
|
| Secondary | Reoperation Rate Through 30-day Post-surgery | A proportion of subjects go through reoperation for the same indication within 30 days post-surgery | subjects who were indicated for robotic-assisted Prostatectomy and Cholecystectomy who underwent procedure with hugo RAS system | Posted | Count of Participants | Participants | 30 days |
|
|
|
|
| Secondary | Device Deficiency Rate | A proportion of subjects with any device deficiency (DD) during robotic assisted surgery using the investigational device | subjects who were indicated for robotic-assisted Prostatectomy and Cholecystectomy received a surgery with the Hugo RAS System. | Posted | Count of Participants | Participants | Peri-operative |
|
|
|
|
| 0 |
| 20 |
| 1 |
| 20 |
| 4 |
| 20 |
| EG001 | RAS Cholecystectomy | 20 subjects indicated for robotic-assisted Cholecystectomy received surgery with the Hugo RAS system | 0 | 20 | 3 | 20 | 2 | 20 |
| Vomiting | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
|
| Small Bowel Nos Perforation | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
|
| Abdominal wall hematoma | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
|
| biliary tract disorder | Hepatobiliary disorders | MedDRA version 26.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA version 26.0 | Systematic Assessment |
|
| Intra-abdominal hemmorrhage | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA version 26.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA version 26.0 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA version 26.0 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA version 26.0 | Systematic Assessment |
|
| Seroma | Injury, poisoning and procedural complications | MedDRA version 26.0 | Systematic Assessment |
|
The PI cannot publish or disclose study results until a multicenter publication is released. If not published within one year after study completion at all sites, the PI may then publish, subject to review. The PI must submit publications to Medtronic 60 days before submission for review. Medtronic can request removal of Confidential Information, corrections, and may delay publication by up to 90 days to protect intellectual property.
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D005705 | Gallbladder Diseases |