ProstatectomyNCT07901049
Hugo™ RAS Urology Post-Market Clinical Study
An observational study of Prostatectomy and Cystectomy, run by Medtronic - MITG.
Trial summary
The purpose of this study is to collect evidence on 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
- Prostatectomy, Cystectomy, Nephrectomy
- What is being tested?
- Robotic Assisted Urologic Surgery
- Type of treatment
- Medical device
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 23 Feb 2027to 31 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: The Medtronic Hugo™ RAS System is intended to be used in this study for urologic surgical procedures including radical prostatectomy, radical cystectomy, nephrectomy (partial/radical). Subject conditions and/or diagnoses may include but are not limited to: prostate cancer, pelvic tumors, interstitial cystitis, congenital abnormalities, end-stage kidney disease (kidney failure), renal tumor, and kidney injury.
Who may be able to join
- Subject is an acceptable candidate for treatment with the Hugo™ RAS System in accordance with the commercial Instructions for Use and local regulations
- Adult subjects (age ≥ 22 years) as required by local law
- Subject has been indicated for a radical prostatectomy, radical cystectomy, and/or partial/radical nephrectomy
- Subject is an acceptable candidate for any surgical approach: fully RAS procedure, laparoscopic surgical procedure, or open surgical procedure
- The subject is willing to participate and consents to participate, as documented by a signed and dated informed consent form in accordance with the Declaration of Helsinki
Who cannot join
- Contraindicated for treatment with the Hugo™ RAS System in accordance with the commercial Instructions for Use and local regulations
- Subject is less than legal age of consent, legally incompetent, or otherwise considered to be part of a vulnerable population (e.g., prisoners or those without sufficient mental capacity)
- Subjects with comorbidities or medical characteristics, which would preclude the surgical procedure in the opinion of the Investigator
- Subject is participating in another clinical investigation at the time of enrollment or has planned participation in another clinical investigation at any time during this study that may influence the results of this study
About this study
Official title: A Prospective, Multi-center, Single-arm, Post-market Study of the Medtronic Hugo™ Robotic-Assisted Surgery (RAS) System in Urologic Surgery
The purpose of this study is to collect evidence on the safety and performance of the Medtronic Hugo™ RAS System when used for urologic RAS procedures.
- Conditions
- Prostatectomy, Cystectomy, Nephrectomy, Urologic Cancer
- Being tested
- Robotic Assisted Urologic Surgery
- Medical subject headings
- Urologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic Assisted Urologic SurgeryDevice
The Medtronic Hugo™ RAS System is intended to be used in this study for urologic surgical procedures including radical prostatectomy, radical cystectomy, nephrectomy (partial/radical) procedures
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Success Rate
Surgical success rate, defined as a Hugo™ RAS procedure free from conversion. A qualifying conversion is an unanticipated switch from a robotic-assisted approach using the Hugo™ RAS System to the use of an alternative robotic-assisted device, laparoscopy, or open surgery.
Measured: Intraoperative
Secondary outcomes (4)
Rate of Complications
Rate of subjects with complications meeting Clavien-Dindo Grade ≥ III from first incision through 30 days postprocedure
Measured: Enrollment through 30 days follow-up
Operative Time
Skin-to-skin operative time
Measured: Intraoperative
Hospital Length of Stay
Total time of hospitalization
Measured: Postoperatively through 30 days follow-up
Mortality
30 Day Mortality Rate
Measured: Enrollment through 30 day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start23 Feb 2027 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProstatectomyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07901049
- Sponsor's protocol ID
- MDT25059
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Single-arm, Post-market Study of the Medtronic Hugo™ Robotic-Assisted Surgery (RAS) System in Urologic Surgery
- ClinicalTrials.gov ID
- NCT07901049
- Acronym / sponsor ID
- MDT25059
- Conditions
- Prostatectomy, Cystectomy, Nephrectomy, Urologic Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- 23 Feb 2027 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to collect evidence on the safety and performance of the Medtronic Hugo™ RAS System when used for urologic RAS procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The Medtronic Hugo™ RAS System is intended to be used in this study for urologic surgical procedures including radical prostatectomy, radical cystectomy, nephrectomy (partial/radical). Subject conditions and/or diagnoses may include but are not limited to: prostate cancer, pelvic tumors, interstitial cystitis, congenital abnormalities, end-stage kidney disease (kidney failure), renal tumor, and kidney injury.
Key inclusion criteria (5 listed)
- Subject is an acceptable candidate for treatment with the Hugo™ RAS System in accordance with the commercial Instructions for Use and local regulations
- Adult subjects (age ≥ 22 years) as required by local law
- Subject has been indicated for a radical prostatectomy, radical cystectomy, and/or partial/radical nephrectomy
- Subject is an acceptable candidate for any surgical approach: fully RAS procedure, laparoscopic surgical procedure, or open surgical procedure
- The subject is willing to participate and consents to participate, as documented by a signed and dated informed consent form in accordance with the Declaration of Helsinki
Key exclusion criteria (4 listed)
- Contraindicated for treatment with the Hugo™ RAS System in accordance with the commercial Instructions for Use and local regulations
- Subject is less than legal age of consent, legally incompetent, or otherwise considered to be part of a vulnerable population (e.g., prisoners or those without sufficient mental capacity)
- Subjects with comorbidities or medical characteristics, which would preclude the surgical procedure in the opinion of the Investigator
- Subject is participating in another clinical investigation at the time of enrollment or has planned participation in another clinical investigation at any time during this study that may influence the results of this study
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 |
|---|---|---|
| Robotic Assisted Urologic SurgeryThe Medtronic Hugo™ RAS System is intended to be used in this study for urologic surgical procedures including radical prostatectomy, radical cystectomy, nephrectomy (partial/radical) procedures | Device | – |
Primary outcome
Surgical Success Rate
Time frame: Intraoperative
Surgical success rate, defined as a Hugo™ RAS procedure free from conversion. A qualifying conversion is an unanticipated switch from a robotic-assisted approach using the Hugo™ RAS System to the use of an alternative robotic-assisted device, laparoscopy, or open surgery.
4 secondary outcomes
Rate of Complications
Time frame: Enrollment through 30 days follow-up
Operative Time
Time frame: Intraoperative
Hospital Length of Stay
Time frame: Postoperatively through 30 days follow-up
Mortality
Time frame: Enrollment through 30 day follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatectomy and Cystectomy, run by Medtronic - MITG.
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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Surgical Success Rate (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2026.