Prostate CancerNCT05715827

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

A study testing RAS prostatectomy and RAS cholecystectomy in people with Prostate Cancer and Cholelithiases, run by Medtronic - MITG at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 22 years and older
Conditions the study is for: Prostate Cancer, Cholelithiases, Cholecystitis
What is being tested?: RAS prostatectomy and RAS cholecystectomy
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 1 siteSouth Korea
Study dates: 12 Feb 2023to 10 Jul 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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

Show all 10Show fewer

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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Seoul National University Hospital
Seoul, Jongno-gu, 03080

Other trials in South Korea

About this study

Official title: A Prospective, Single-center, Single-arm, Pivotal Trial to Evaluate Safety and Efficacy of the Medtronic Hugo™ Robotic Assisted Surgery (RAS) System (Hello Hugo)

Read the 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.

Conditions: Prostate Cancer, Cholelithiases, Cholecystitis, Gallbladder Polyp
Being tested: RAS prostatectomy and RAS cholecystectomy
Medical subject headings: Prostatic Neoplasms, Cholelithiasis, Cholecystitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RAS prostatectomy and RAS cholecystectomyDevice
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.

Study groups in NCT05715827
Study group	Role	What they receive
Robotic Assisted Surgery (RAS)	Experimental	Robotic Assisted radical prostatectomy and cholecystectomy Receives: Device: RAS prostatectomy and RAS cholecystectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 24 hours

Secondary outcomes (5)

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
Measured: 30 days
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."
Measured: 30 days
Readmission Rate Through 30-day Post-surgery
A proportion of subjects hospitalized within 30 days post-surgery
Measured: 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
Measured: 30 days
Device Deficiency Rate
A proportion of subjects with any device deficiency (DD) during robotic assisted surgery using the investigational device
Measured: Peri-operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Feb 202310 Jul 2023

First posted8 Feb 2023
Study start12 Feb 2023
Primary completion5 Jun 2023
Study completion10 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Prostate CancerStudies of the same condition, open and under way.
More trials run by Medtronic - MITGThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05715827
Sponsor's protocol ID: MDT21028
Status last verified: Oct 2024
First submitted: 27 Jan 2023
Last updated: 5 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 39466427

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Single-center, Single-arm, Pivotal Trial to Evaluate Safety and Efficacy of the Medtronic Hugo™ Robotic Assisted Surgery (RAS) System (Hello Hugo)
ClinicalTrials.gov ID: NCT05715827
Acronym / sponsor ID: MDT21028
Conditions: Prostate Cancer, Cholelithiases, Cholecystitis, Gallbladder Polyp
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Medtronic - MITGIndustry (pharma, biotech, devices)
Study start: 12 Feb 2023 (actual)
Primary completion: 5 Jun 2023 (actual)
Study completion: 10 Jul 2023 (actual)
First posted: 8 Feb 2023 (actual)
Results: Posted 5 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Robotic Assisted Surgery (RAS)	Experimental	Device: RAS prostatectomy and RAS cholecystectomyRobotic Assisted radical prostatectomy and cholecystectomy

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RAS prostatectomy and RAS cholecystectomyThere 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.	Device	Robotic Assisted Surgery (RAS)

Primary outcome

Completion Rate
Time frame: 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.

5 secondary outcomes

Overall Complication Rate Through 30-day Post-surgery
Time frame: 30 days
Major Complication Rate Through 30-day Post-surgery
Time frame: 30 days
Readmission Rate Through 30-day Post-surgery
Time frame: 30 days
Reoperation Rate Through 30-day Post-surgery
Time frame: 30 days
Device Deficiency Rate
Time frame: Peri-operative

Results and safety

Results posted to the registry on 5 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Robotic Assisted Radical Prostatectomy	20	20
Robotic-assisted Cholecystectomy	22	20

Primary outcome: Completion Rate

Time frame: 24 hours. Count of participants. Unit: Participants

Measure	RAS Prostatectomy n = 20	RAS Cholecystectomy n = 20
Value	20	19

RAS Prostatectomy vs RAS Cholecystectomy: Completion rate: 97.5 (95% CI 86.8 to 99.9)

Population analysed: 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.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
RAS Prostatectomy	1 of 20 (5%)	4 of 20 (20%)	0 of 20
RAS Cholecystectomy	3 of 20 (15%)	2 of 20 (10%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39466427Kwon 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing RAS prostatectomy and RAS cholecystectomy in people with Prostate Cancer and Cholelithiases, run by Medtronic - MITG at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Completion Rate (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05715827, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.