Academic Journal
The first United States prospective trial using the Hugo™ robot-assisted surgery system.
| Title: | The first United States prospective trial using the Hugo™ robot-assisted surgery system. |
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| Authors: | Abern MR; Duke University School of Medicine, Durham, NC, USA., Wiklund P; Icahn School of Medicine at Mount Sinai, New York, NY, USA., Goh AC; Memorial Sloan Kettering Cancer Center, New York, NY, USA., Kaouk JH; Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, OH, USA., Crivellaro S; University of Illinois Chicago, Chicago, IL, USA., Lau CS; City of Hope National Medical Center, Duarte, CA, USA., Zhumkhawala AA; City of Hope National Medical Center, Duarte, CA, USA., Huang R; Swedish Medical Center First Hill, Seattle, WA, USA., Mehrazin R; Icahn School of Medicine at Mount Sinai, New York, NY, USA., Sfakianos JP; Icahn School of Medicine at Mount Sinai, New York, NY, USA., Madueke I; University of Illinois Chicago, Chicago, IL, USA., Inman BA; Duke University School of Medicine, Durham, NC, USA.; Western University and London Health Sciences Center, London, Ontario, Canada., Blaser C; Medtronic, Minneapolis, MN, USA., Masters M; Medtronic, Minneapolis, MN, USA., Porter JR; Swedish Medical Center First Hill, Seattle, WA, USA.; Medtronic, Minneapolis, MN, USA. |
| Source: | BJU international [BJU Int] 2026 Jul; Vol. 138 (1), pp. 85-91. Date of Electronic Publication: 2026 May 14. |
| Publication Type: | Journal Article; Multicenter Study; Clinical Trial |
| Language: | English |
| Journal Info: | Publisher: Blackwell Science Country of Publication: England NLM ID: 100886721 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1464-410X (Electronic) Linking ISSN: 14644096 NLM ISO Abbreviation: BJU Int Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: Oxford, UK : Blackwell Science, c1999- |
| MeSH Terms: | Robotic Surgical Procedures*/instrumentation , Robotic Surgical Procedures*/adverse effects , Robotic Surgical Procedures*/methods , Nephrectomy*/methods , Nephrectomy*/adverse effects , Nephrectomy*/instrumentation , Cystectomy*/methods , Cystectomy*/instrumentation , Cystectomy*/adverse effects , Prostatectomy*/methods , Prostatectomy*/instrumentation , Prostatectomy*/adverse effects, Postoperative Complications/epidemiology ; Humans ; Male ; Prospective Studies ; Aged ; Middle Aged ; United States ; Female ; Treatment Outcome |
| Abstract: | Objective: To 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 Methods: The 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. Results: A 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. Conclusion: The 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. (© 2026 The Author(s). BJU International published by John Wiley & Sons Ltd on behalf of BJU International.) |
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| Grant Information: | P30 CA008748 United States CA NCI NIH HHS; Medtronic |
| Contributed Indexing: | Keywords: Hugo RAS system; cystectomy; nephrectomy; prostatectomy; robot‐assisted surgery |
| Molecular Sequence: | ClinicalTrials.gov NCT05696444 |
| Entry Date(s): | Date Created: 20260514 Date Completed: 20260611 Latest Revision: 20260726 |
| Update Code: | 20260726 |
| PubMed Central ID: | PMC13244583 |
| DOI: | 10.1111/bju.70314 |
| PMID: | 42132526 |
| Database: | MEDLINE |
| ISSN: | 1464-410X |
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| DOI: | 10.1111/bju.70314 |