Cholecystitis, Cholelithiases, Gallbladder Polyp, Prostate Cancer
Conditions
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.
Detailed description
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.
Interventions
DEVICERAS prostatectomy and RAS cholecystectomy
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.
Sponsors
Medtronic - MITG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion Rate | 24 hours | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall Complication Rate Through 30-day Post-surgery | 30 days | A proportion of subjects with any post-operative complication within 30-days post-surgery using the investigational device |
| Major Complication Rate Through 30-day Post-surgery | 30 days | 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. |
| Readmission Rate Through 30-day Post-surgery | 30 days | A proportion of subjects hospitalized within 30 days post-surgery |
| Reoperation Rate Through 30-day Post-surgery | 30 days | A proportion of subjects go through reoperation for the same indication within 30 days post-surgery |
| Device Deficiency Rate | Peri-operative | A proportion of subjects with any device deficiency (DD) during robotic assisted surgery using the investigational device |
Countries
South Korea
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| Robotic Assisted Cholecystectomy The study population will consist of patients 22 years of age or older indicated for a robotic assisted cholecystectomy with Hugo™ RAS. | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | console communication error | 0 | 1 |
| Overall Study | Physician Decision | 0 | 1 |
Baseline characteristics
| Characteristic | Robotic Assisted Prostatectomy | Robotic Assisted Cholecystectomy | Total |
|---|---|---|---|
| Age, Continuous | 69 years | 58 years | 63 years |
| BMI | 24.7 kg/m2 | 23.9 kg/m2 | 24.6 kg/m2 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment South Korea | 20 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 0 Participants | 12 Participants | 12 Participants |
| Sex: Female, Male Male | 20 Participants | 8 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 4 / 20 | 2 / 20 |
| serious Total, serious adverse events | 1 / 20 | 3 / 20 |
Outcome results
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.
Time frame: 24 hours
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RAS Prostatectomy | Completion Rate | 20 Participants |
| RAS Cholecystectomy | Completion Rate | 19 Participants |
Comparison: The study aimed to confirm the Medtronic Hugo™ RAS System's performance for prostatectomy or cholecystectomy, targeting a 95% completion rate (no conversion due to system issues or major complications within 24 hours). The Full Analysis Set (FAS) included all subjects starting the procedure. Descriptive statistics and 95% confidence intervals were used to assess primary and secondary endpoints, confirming safety and effectiveness.95% CI: [86.8, 99.9]
Secondary
Device Deficiency Rate
A proportion of subjects with any device deficiency (DD) during robotic assisted surgery using the investigational device
Time frame: Peri-operative
Population: subjects who were indicated for robotic-assisted Prostatectomy and Cholecystectomy received a surgery with the Hugo RAS System.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RAS Prostatectomy | Device Deficiency Rate | 10 Participants |
| RAS Cholecystectomy | Device Deficiency Rate | 3 Participants |
Comparison: The secondary objective is to assess the short-term safety outcome of the Medtronic Hugo™ RAS System when used for prostatectomy or cholecystectomy. Overall complication rate through 30-day post-surgery: A proportion of subjects with any postoperative complication within 30-days post-surgery using the investigational device95% CI: [18.6, 49.1]
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.
Time frame: 30 days
Population: subjects indicated for robotic-assisted Cholecystectomy received surgery with Hugo RAS System
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RAS Prostatectomy | Major Complication Rate Through 30-day Post-surgery | 0 Participants |
| RAS Cholecystectomy | Major Complication Rate Through 30-day Post-surgery | 2 Participants |
Comparison: The secondary objective is to assess the short-term safety outcome of the Medtronic Hugo™ RAS System when used for prostatectomy or cholecystectomy. Overall complication rate through 30-day post-surgery: A proportion of subjects with any postoperative complication within 30-days post-surgery using the investigational device95% CI: [0.6, 16.9]
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
Time frame: 30 days
Population: subjects who were indicated for robotic-assisted Prostatectomy and Cholecystectomy who went under procedure with Hugo RAS System
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RAS Prostatectomy | Overall Complication Rate Through 30-day Post-surgery | 5 Participants |
| RAS Cholecystectomy | Overall Complication Rate Through 30-day Post-surgery | 3 Participants |
Comparison: The secondary objective is to assess the short-term safety outcome of the Medtronic Hugo™ RAS System when used for prostatectomy or cholecystectomy. Overall complication rate through 30-day post-surgery: A proportion of subjects with any postoperative complication within 30-days post-surgery using the investigational device95% CI: [9.1, 35.6]
Secondary
Readmission Rate Through 30-day Post-surgery
A proportion of subjects hospitalized within 30 days post-surgery
Time frame: 30 days
Population: subjects who were indicated for robotic-assisted Prostatectomy and Cholecystectomy underwent the procedure with Hugo RAS system
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RAS Prostatectomy | Readmission Rate Through 30-day Post-surgery | 1 Participants |
| RAS Cholecystectomy | Readmission Rate Through 30-day Post-surgery | 3 Participants |
Comparison: The secondary objective is to assess the short-term safety outcome of the Medtronic Hugo™ RAS System when used for prostatectomy or cholecystectomy. Overall complication rate through 30-day post-surgery: A proportion of subjects with any postoperative complication within 30-days post-surgery using the investigational device95% CI: [2.8, 23.7]
Secondary
Reoperation Rate Through 30-day Post-surgery
A proportion of subjects go through reoperation for the same indication within 30 days post-surgery
Time frame: 30 days
Population: subjects who were indicated for robotic-assisted Prostatectomy and Cholecystectomy who underwent procedure with hugo RAS system
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RAS Prostatectomy | Reoperation Rate Through 30-day Post-surgery | 0 Participants |
| RAS Cholecystectomy | Reoperation Rate Through 30-day Post-surgery | 0 Participants |
Comparison: The secondary objective is to assess the short-term safety outcome of the Medtronic Hugo™ RAS System when used for prostatectomy or cholecystectomy. Overall complication rate through 30-day post-surgery: A proportion of subjects with any postoperative complication within 30-days post-surgery using the investigational device