Evidence map›Paper›PMID 42132526›Full record

Trial reportBJU international2026

The first United States prospective trial using the Hugo™ robot-assisted surgery system.

Michael R Abern, Peter Wiklund, Alvin C Goh, Jihad H Kaouk, Simone Crivellaro, Clayton S Lau, Ali A Zhumkhawala, Rogerio Huang, Reza Mehrazin, John P Sfakianos and 5 more

Registry-linked trialAbstract readMulticenter StudyClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BJU international, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05696444 (A Prospective, Multi-center, Single-arm Study of the Medtronic Hugo™ Robotic Assisted Surgery), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05696444 naactive not recruitingnot on this map

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

TypeinterventionalSponsorMedtronic - MITGRan2022 to 2030Enrolled144ConditionsBladder Cancer, Prostate Cancer, Kidney Cancer, Pelvic TumorArmsRAS Prostatectomy, RAS Cystectomy, RAS Nephrectomy
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Michael R AbernDuke University School of Medicine, Durham, NC, USA.ORCID 0000-0003-2938-4768
Peter WiklundIcahn School of Medicine at Mount Sinai, New York, NY, USA.
Alvin C GohMemorial Sloan Kettering Cancer Center, New York, NY, USA.
Jihad H KaoukGlickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, OH, USA.
Simone CrivellaroUniversity of Illinois Chicago, Chicago, IL, USA.
Clayton S LauCity of Hope National Medical Center, Duarte, CA, USA.
Ali A ZhumkhawalaCity of Hope National Medical Center, Duarte, CA, USA.
Rogerio HuangSwedish Medical Center First Hill, Seattle, WA, USA.
Reza MehrazinIcahn School of Medicine at Mount Sinai, New York, NY, USA.
John P SfakianosIcahn School of Medicine at Mount Sinai, New York, NY, USA.
Ikenna MaduekeUniversity of Illinois Chicago, Chicago, IL, USA.
Brant A InmanDuke University School of Medicine, Durham, NC, USA.ORCID 0000-0002-6060-4485
Casey BlaserMedtronic, Minneapolis, MN, USA.
Michele MastersMedtronic, Minneapolis, MN, USA.
James R PorterSwedish Medical Center First Hill, Seattle, WA, USA.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
MedtronicNCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

objectiveTo describe the safety and effectiveness of the Hugo™ robot-assisted surgery (RAS) system (Medtronic, Minneapolis, MN, USA) when used for three urological procedures. PATIENTS AND

methodsThe Expand URO (ClinicalTrials.gov identifier: NCT05696444) was the first investigational study for the Hugo RAS system based in the United States. It was a prospective, single-arm, multicentre clinical trial conducted at six medical centres. Patients indicated for radical prostatectomy (RP), radical cystectomy (RC), or partial or radical nephrectomy were enrolled from December 2022 to September 2024. The primary effectiveness endpoint was surgical success (freedom from conversion) and was hypothesised to be >85% for the three procedures combined. The primary safety endpoint was the 30-day major complication (Clavien-Dindo Grade ≥III) rate, hypothesised to be below 20%, 45%, and 20% for RP, RC, and nephrectomy, respectively. Secondary endpoints included operative characteristics and postoperative outcomes through 30 days.

resultsA total of 144 patients were enrolled, and 137 underwent a procedure (55 RPs, 29 RCs, 53 nephrectomies). The conversion rate was low (1.5%) resulting in a surgical success rate of 98.5% across all procedures. The major complication rates for RP, RC, and nephrectomy were 3.7%, 17.9%, and 1.9%, respectively. Of the 137 treated patients, 124 were oncological patients. The overall positive surgical margin rates were 21.8%, 7.1%, and 2.4% in RP, RC, and nephrectomy, respectively.

conclusionThe Expand URO study achieved its primary endpoints for safety and effectiveness. Operative characteristics and short-term postoperative outcomes obtained with the Hugo RAS system were consistent with those in the literature.

Indexed as

CystectomyNephrectomyProstatectomyRobotic Surgical ProceduresAgedFemaleHumansMaleMiddle AgedPostoperative ComplicationsProspective StudiesTreatment OutcomeUnited StatescystectomyHugo RAS systemnephrectomyprostatectomyrobot‐assisted surgery

Identifiers

PMID42132526
PMCPMC13244583

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.