Bladder CancerNCT05696444

Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO)

A study testing RAS Prostatectomy, RAS Cystectomy and RAS Nephrectomy in people with Bladder Cancer and Prostate Cancer, run by Medtronic - MITG at 6 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

This study will evaluate the safety and performance of the Medtronic Hugo™ RAS System when used for urologic RAS procedures. Read more about this study

Who is it for?: Ages 22 years and older
Conditions the study is for: Bladder Cancer, Prostate Cancer, Kidney Cancer
What is being tested?: RAS Prostatectomy, RAS Cystectomy and RAS Nephrectomy
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 144 participants
Where: 6 sitesUnited States
Study dates: 14 Dec 2022to 31 Jan 2030
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 (age ≥ 22 years) as required by local law
Subject has been indicated for a radical prostatectomy, radical cystectomy, or nephrectomy (partial or radical) surgical procedure
Subject is an acceptable candidate for a fully robotic assisted surgical procedure, a laparoscopic surgical procedure, or an open surgical procedure
The subject is willing to participate and consents to participate, as documented by a signed and dated informed consent form

Who cannot join

Subjects for which minimally invasive surgery is contraindicated as determined by the Investigator
Subjects with comorbidities or medical characteristics, which would preclude the surgical procedure in the opinion of the Investigator
Subjects diagnosed with a bleeding disorder and/or cannot be removed from their anticoagulants prior to surgery based on surgeon discretion and standard-of-care
Non-oncology subjects with an estimated life expectancy of less than 6 months; oncology subjects considered for cystectomy with a life expectancy less than 24 months; oncology subjects considered for nephrectomy with a life expectancy less than 60 months; oncology subjects considered for prostatectomy with less than a 10-year life expectancy.
Female subjects pregnant at the time of the surgical procedure.
Subjects who are considered to be part of a vulnerable population (e.g., prisoners or those without sufficient mental capacity)
Subjects who have participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study
Subjects with active infections including but not limited to pneumonia, urinary tract, cellulitis, or bacteremia

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

University of Chiago
Chicago, Illinois, 60612
Cleveland Clinic
Cleveland, Ohio, 44195
City of Hope
Duarte, California, 91010
Duke Medical Center
Durham, North Carolina, 27710
Mount Sinai
New York, New York, 10029
Swedish Medical Center
Seattle, Washington, 98122

Other trials in United States

About this study

Official title: A Prospective, Multi-center, Single-arm Study of the Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO)

This study will evaluate the safety and performance of the Medtronic Hugo™ RAS System when used for urologic RAS procedures.

Read the detailed description

A prospective, multicenter, single-arm pivotal study in subjects undergoing a urologic RAS procedure using the Medtronic Hugo™ RAS System. Subjects without an oncologic indication will be followed for 30 days post-procedure. Oncologic subjects will be followed annually through 5 years. The study will be conducted in up to 6 investigative sites in the United States of America (USA).

Conditions: Bladder Cancer, Prostate Cancer, Kidney Cancer, Pelvic Tumor, Interstitial Cystitis, Congenital Abnormalities
Being tested: RAS Prostatectomy, RAS Cystectomy, RAS Nephrectomy
Medical subject headings: Urinary Bladder Neoplasms, Prostatic Neoplasms, Kidney Neoplasms, Pelvic Neoplasms, Cystitis, Interstitial, Congenital Abnormalities, Kidney Failure, Chronic, Carcinoma, Renal Cell

What participants receive

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

RAS ProstatectomyDevice
Subjects indicated for Robotic Assisted Surgery (RAS) for prostatectomy will have RAS surgery using the Medtronic Hugo RAS system.
RAS CystectomyDevice
Subjects indicated for Robotic Assisted Surgery (RAS) for cystectomy will have RAS surgery using the Medtronic Hugo RAS system.
RAS NephrectomyDevice
Subjects indicated for Robotic Assisted Surgery (RAS) for nephrectomy (Radical/Partial) will have RAS surgery using the Medtronic Hugo RAS system.

Study groups in NCT05696444
Study group	Role	What they receive
Robotic Assisted Surgery (RAS) Urologic Surgery	Other	Robotic Assisted Surgery (RAS) urologic surgery under the umbrella of procedures outlined by the FDA (prostatectomy, cystectomy and nephrectomy). Receives: Device: RAS Prostatectomy; Device: RAS Cystectomy; Device: RAS Nephrectomy

What is being measured

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

Primary Effectiveness Endpoint - Surgical Success Rate, Defined as the Procedure Not Going Into Conversion
The primary effectiveness endpoint is the surgical success rate, defined as the procedure not going into conversion. Conversion is defined as the switch from a robotic assisted approach using the Hugo system to a robotic assisted approach utilizing an FDA cleared robotic-assisted device, laparoscopic, or open surgery.
Measured: During surgical procedure
Primary Safety Endpoint - Rate of Subjects With Complications Meeting Grade III - Grade V Criteria Per the Clavien-Dindo Classification System.
Complications meeting Grade III criteria or higher per the Clavien-Dindo Classification system, from first incision through 30 days post-procedure.
Clavien-Dindo Classification of Surgical Complications:
Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions.
Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included.
Grade III: Requiring surgical, endoscopic or radiological intervention Grade IIIa: Intervention not under general anesthesia Grade IIIb: Intervention under general anesthesia Grade IV: Life-threatening complication requiring IC/ICU management Grade IVa: Single organ dysfunction (including dialysis) Grade IVb: Multiorgan dysfunction Grade V: Death of a patient
Measured: 30 days

Secondary outcomes (12)

Secondary Endpoint - Overall Complication Rate From First Incision Through 30 Days Post-procedure.
Complication rate: Overall rate of subjects with one or more complications (Clavien-Dindo Grade I or higher), from the first incision through 30 days post-procedure.
Measured: 30 days
Secondary Endpoint - Operative Time (Min)
Operative time shall be collected through the length of the procedure.
Measured: up to 720 minutes
Secondary Endpoint - Intraoperative Estimated Blood Loss (mL).
Intraoperative estimated blood loss shall be collected through the length of the procedure.
Measured: intraoperative
Secondary Endpoint - Transfusion Rate Through 30 Days.
Transfusion rate shall be collected through 30 days post-procedure
Measured: 30 days
Secondary Endpoint - Rate of Device-related Conversions
Rate of device-related conversions shall be collected through the length of the procedure.
Measured: intraoperative
Secondary Endpoint - Hospital Length of Stay (Days)
Hospital length of stay (days) shall be collected through 30 days post-procedure.
Measured: 30 days
Secondary Endpoint - Readmission Rate (Through 30 Days)
Readmission rate shall be collected though 30 days post-procedure.
Measured: 30 days
Secondary Endpoint - Reoperation Rate (Through 30 Days).
Reoperation rate shall be collected through 30 days post-procedure.
Measured: 30 days
Secondary Endpoint - Mortality Rate (Through 30 Days).
Mortality rate shall be collected through 30 days post-procedure.
Measured: 30 days
Secondary Endpoint - Progression-free Survival
Progression-free survival rate will be assessed through 5 years in oncologic subjects.
Measured: 5 years
Secondary Endpoint - Disease-free Survival
Disease-free survival rate will be assessed through 5 years in oncologic subjects.
Measured: 5 years
Secondary Endpoint - Overall Survival
Overall survival rate will be assessed through 5 years in oncologic subjects.
Measured: 5 years

Timeline

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

14 Dec 202231 Jan 2030

First posted25 Jan 2023
Study start14 Dec 2022
Primary completion10 Oct 2024
Study completion31 Jan 2030 (estimated)

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 Bladder 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
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 144 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05696444
Sponsor's protocol ID: MDT19051EINURO
Status last verified: Oct 2026
First submitted: 18 Nov 2022
Last updated: 3 Nov 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Abern MR, Wiklund P, Goh AC, Kaouk JH, Crivellaro S, Lau CS, Zhumkhawala AA, Huang R, Mehrazin R, Sfakianos JP, Madueke I, Inman BA, Blaser C, Masters M, Porter JR. The first United States prospective trial using the Hugo robot-assisted surgery system. BJU Int. 2026 Jul;138(1):85-91. doi: 10.1111/bju.70314. Epub 2026 May 14.
PubMed 42132526

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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All Bladder Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multi-center, Single-arm Study of the Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO)
ClinicalTrials.gov ID: NCT05696444
Acronym / sponsor ID: MDT19051EINURO
Conditions: Bladder Cancer, Prostate Cancer, Kidney Cancer, Pelvic Tumor, Interstitial Cystitis, Congenital Abnormalities
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 144 participants (actual)
Lead sponsor: Medtronic - MITGIndustry (pharma, biotech, devices)
Study start: 14 Dec 2022 (actual)
Primary completion: 10 Oct 2024 (actual)
Study completion: 31 Jan 2030 (estimated)
First posted: 25 Jan 2023 (actual)
Results: Posted 25 Nov 2025

Clinical summary

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

This study will evaluate the safety and performance of the Medtronic Hugo™ RAS System when used for urologic RAS procedures.

Detailed description

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) Urologic Surgery	Other	Device: RAS Prostatectomy, Device: RAS Cystectomy, Device: RAS NephrectomyRobotic Assisted Surgery (RAS) urologic surgery under the umbrella of procedures outlined by the FDA (prostatectomy, cystectomy and nephrectomy).

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 (age ≥ 22 years) as required by local law
Subject has been indicated for a radical prostatectomy, radical cystectomy, or nephrectomy (partial or radical) surgical procedure
Subject is an acceptable candidate for a fully robotic assisted surgical procedure, a laparoscopic surgical procedure, or an open surgical procedure
The subject is willing to participate and consents to participate, as documented by a signed and dated informed consent form

Key exclusion criteria (8 listed)

Subjects for which minimally invasive surgery is contraindicated as determined by the Investigator
Subjects with comorbidities or medical characteristics, which would preclude the surgical procedure in the opinion of the Investigator
Subjects diagnosed with a bleeding disorder and/or cannot be removed from their anticoagulants prior to surgery based on surgeon discretion and standard-of-care
Non-oncology subjects with an estimated life expectancy of less than 6 months; oncology subjects considered for cystectomy with a life expectancy less than 24 months; oncology subjects considered for nephrectomy with a life expectancy less than 60 months; oncology subjects considered for prostatectomy with less than a 10-year life expectancy.
Female subjects pregnant at the time of the surgical procedure.

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 ProstatectomySubjects indicated for Robotic Assisted Surgery (RAS) for prostatectomy will have RAS surgery using the Medtronic Hugo RAS system.	Device	Robotic Assisted Surgery (RAS) Urologic Surgery
RAS CystectomySubjects indicated for Robotic Assisted Surgery (RAS) for cystectomy will have RAS surgery using the Medtronic Hugo RAS system.	Device	Robotic Assisted Surgery (RAS) Urologic Surgery
RAS NephrectomySubjects indicated for Robotic Assisted Surgery (RAS) for nephrectomy (Radical/Partial) will have RAS surgery using the Medtronic Hugo RAS system.	Device	Robotic Assisted Surgery (RAS) Urologic Surgery

Primary outcome

Primary Effectiveness Endpoint - Surgical Success Rate, Defined as the Procedure Not Going Into Conversion
Time frame: During surgical procedure
The primary effectiveness endpoint is the surgical success rate, defined as the procedure not going into conversion. Conversion is defined as the switch from a robotic assisted approach using the Hugo system to a robotic assisted approach utilizing an FDA cleared robotic-assisted device, laparoscopic, or open surgery.
Primary Safety Endpoint - Rate of Subjects With Complications Meeting Grade III - Grade V Criteria Per the Clavien-Dindo Classification System.
Time frame: 30 days
Complications meeting Grade III criteria or higher per the Clavien-Dindo Classification system, from first incision through 30 days post-procedure. Clavien-Dindo Classification of Surgical Complications: Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions. Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included. Grade III: Requiring surgical, endoscopic or radiological intervention Grade IIIa: Intervention not under general anesthesia Grade IIIb: Intervention under general anesthesia Grade IV: Life-threatening complication requiring IC/ICU management Grade IVa: Single organ dysfunction (including dialysis) Grade IVb: Multiorgan dysfunction Grade V: Death of a patient

12 secondary outcomes

Secondary Endpoint - Overall Complication Rate From First Incision Through 30 Days Post-procedure.
Time frame: 30 days
Secondary Endpoint - Operative Time (Min)
Time frame: up to 720 minutes
Secondary Endpoint - Intraoperative Estimated Blood Loss (mL).
Time frame: intraoperative
Secondary Endpoint - Transfusion Rate Through 30 Days.
Time frame: 30 days
Secondary Endpoint - Rate of Device-related Conversions
Time frame: intraoperative
Secondary Endpoint - Hospital Length of Stay (Days)
Time frame: 30 days
Secondary Endpoint - Readmission Rate (Through 30 Days)
Time frame: 30 days
Secondary Endpoint - Reoperation Rate (Through 30 Days).
Time frame: 30 days
Secondary Endpoint - Mortality Rate (Through 30 Days).
Time frame: 30 days
Secondary Endpoint - Progression-free Survival
Time frame: 5 years
Secondary Endpoint - Disease-free Survival
Time frame: 5 years
Secondary Endpoint - Overall Survival
Time frame: 5 years

Results and safety

Results posted to the registry on 25 Nov 2025, 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 Surgery (RAS) Urologic Surgery - Prostatectomy	55	55
Robotic Assisted Surgery (RAS) Urologic Surgery - Cystectomy	29	28
Robotic Assisted Surgery (RAS) Urologic Surgery - Nephrectomy	53	53

Primary outcome: Primary Effectiveness Endpoint - Surgical Success Rate, Defined as the Procedure Not Going Into Conversion

Time frame: During surgical procedure. Count of participants. Unit: Participants

Measure	Robotic Assisted Surgery (RAS) Urologic Surgery n = 136
Value	134

Robotic Assisted Surgery (RAS) Urologic Surgery: p <0.0001, Exact test

Population analysed: One subject in the cystectomy cohort who met the criteria to be included in the Full Analysis set (FAS), as they received their first incision with intent of using Hugo, was excluded from the analysis as their procedure was aborted after an hour of exploration due to an advanced disease state. Data from the three RAS Urologic Surgery cohorts: Prostatectomy, Cystectomy, \& Nephrectomy were combined for analysis per pre-specified analysis plan.

Primary outcome: Primary Safety Endpoint - Rate of Subjects With Complications Meeting Grade III - Grade V Criteria Per the Clavien-Dindo Classification System.

Time frame: 30 days. Count of participants. Unit: Participants

Measure	Robotic Assisted Surgery (RAS) Urologic Surgery - Prostatectomy n = 54	Robotic Assisted Surgery (RAS) Urologic Surgery - Cystectomy n = 28	Robotic Assisted Surgery (RAS) Urologic Surgery - Nephrectomy n = 52
Value	2	5	1

Robotic Assisted Surgery (RAS) Urologic Surgery - Prostatectomy: p = 0.0006, Exact test
Robotic Assisted Surgery (RAS) Urologic Surgery - Cystectomy: p = 0.0025, Exact test
Robotic Assisted Surgery (RAS) Urologic Surgery - Nephrectomy: p = 0.0001, Exact test

Population analysed: Three subjects (1 prostatectomy, 1 cystectomy, 1 nephrectomy) had a missed 30-day follow-up visit. Subjects must have met one of the following conditions to be included: * They experienced a documented major complication within 30 days of the index procedure, regardless of whether the 30-day visit occurred. OR * They completed their 30-day visit, confirming that no major complication occurred.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: All Adverse Events were collected from the time of consent through 30 days post procedure.. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Robotic Assisted Surgery (RAS) Urologic Surgery - Prostatectomy	5 of 55 (9.1%)	19 of 55 (34.5%)	1 of 55
Robotic Assisted Surgery (RAS) Urologic Surgery - Cystectomy	15 of 29 (51.7%)	7 of 29 (24.1%)	1 of 29
Robotic Assisted Surgery (RAS) Urologic Surgery - Nephrectomy	7 of 53 (13.2%)	6 of 53 (11.3%)	0 of 53

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42132526Abern MR, Wiklund P, Goh AC, Kaouk JH, Crivellaro S, Lau CS, Zhumkhawala AA, Huang R, Mehrazin R, Sfakianos JP, Madueke I, Inman BA, Blaser C, Masters M, Porter JR. The first United States prospective trial using the Hugo robot-assisted surgery system. BJU Int. 2026 Jul;138(1):85-91. doi: 10.1111/bju.70314. Epub 2026 May 14.
Individual participant dataSharing planned: No

Related trials for Bladder Cancer

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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.

Michael Abern, MD study chair

Duke Medical Center

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

Questions about this trial

What is this clinical trial studying?

A study testing RAS Prostatectomy, RAS Cystectomy and RAS Nephrectomy in people with Bladder Cancer and Prostate Cancer, run by Medtronic - MITG at 6 sites in United States.

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 8 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: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. 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 25 Nov 2025). 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?

Primary Effectiveness Endpoint - Surgical Success Rate, Defined as the Procedure Not Going Into Conversion (time frame: During surgical procedure). The study lists 2 primary outcomes in all. 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 NCT05696444, 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 3 Nov 2026.