Robotic Endoscopy System Achieves Flawless En Bloc Resection in First-in-Human Bladder Tumor Trial

A novel robotic surgical platform, the Virtuoso Endoscopy System (VES), has demonstrated exceptional technical feasibility and safety in its first-in-human trial for the transurethral excision of bladder lesions. The Phase 1 VIABLE trial achieved a 100% success rate for en bloc or modified en bloc resection across all 12 lesions treated, with perfect results for the primary endpoint: detrusor muscle presence in the specimen (100%), a critical factor for accurate cancer staging.

Historically, the gold standard for removing non-muscle-invasive bladder cancer is conventional Transurethral Resection of Bladder Tumour (cTURBT). However, cTURBT has three major limitations: Poor Staging, Increased Recurrence and Unassessable Margins. En bloc resection of bladder tumor (ERBT), which removes the tumor in one intact piece, has been proposed as a superior technique, shown in studies like the EB-StaR trial to significantly reduce the 1-year recurrence rate. However, ERBT is technically challenging, limiting its global adoption.

The VES is a groundbreaking robotic system specifically designed to overcome the technical hurdles of advanced transurethral surgery like ERBT. The system features dexterous 1-mm arms manipulated through a standard-sized scope. The instruments use a set of nested, curved, superelastic nitinol tubes that allow precise, remotely controlled movements. This design enables urologists to perform complex ERBT via the urethra with continuous visual feedback and control.

The single-center, single-arm Phase 1 VIABLE trial (NCT06940648) evaluated the VES in six patients with a total of 12 bladder lesions. The mean procedural time was 52 ± 20 minutes.

The results for the effectiveness endpoints were outstanding:

• En Bloc Rate: 100% – All 12 bladder lesions were excised successfully using the en bloc or modified en bloc technique.

• Accurate Staging: 100% – Detrusor muscle, the primary effectiveness endpoint and a key measure of surgical quality, was present in every single specimen.

• Evaluable Margins: 91% – Evaluable resection margins were obtained in 10 of 11 urothelial tumors, a substantial improvement over conventional techniques.

• Zero Conversion: None of the patients required conversion to standard cTURBT equipment.

• Intraoperative Safety: There were no intraoperative adverse events, complications, or bladder perforations.

• Postoperative Safety: Only two patients (33%) experienced postoperative adverse events, with only one (acute urinary retention) classified as a minor Clavien-Dindo grade 1 complication that resolved conservatively.

The VES demonstrated technical dexterity even in challenging cases, including tumors near the ureteric orifice and a case requiring 180° flipping of the instrument drive unit to access an anterior wall tumor. The promising technical outcomes (100% detrusor muscle presence and 91% evaluable margins) suggest that the VES directly addresses the key limitations of conventional TURBT. By improving the quality of the surgical specimen, the system has the potential to enhance prognostic information and facilitate more accurate subsequent treatment decisions for patients.

The VES has already received US FDA breakthrough device designation, highlighting its potential to offer a more effective treatment for this life-threatening condition. The researchers now plan to proceed with Phase 2, a multisite study comparing VES to cTURBT to further validate the system's role in changing the standard of care.

Reference: A Novel Transurethral Robotic Platform for Performing En Bloc Resection of Bladder Tumour: Results from the First Phase of the VIABLE Trial. Teoh, Jeremy Yuen-Chun et al. European Urology Oncology