4.6 Editorial Material

Versius in urology: an IDEAL start

Related references

Note: Only part of the references are listed.
Article Surgery

An Early Prospective Clinical Study to Evaluate the Safety and Performance of the Versius Surgical System in Robot-Assisted Cholecystectomy

Dhananjay S. Kelkar et al.

Summary: The study aims to demonstrate the successful and safe completion of cholecystectomy using the Versius Surgical System. Results from the cholecystectomy cohort of a clinical trial show that the device is as safe and effective as conventional laparoscopy, supporting its wider implementation.

ANNALS OF SURGERY (2023)

Review Surgery

Beyond the RCT: When are Randomized Trials Unnecessary for New Therapeutic Devices, and What Should We Do Instead?

Arsenio Paez et al.

Summary: The aim of this study was to develop an evidence-based framework for evaluation of therapeutic devices, based on ethical principles and clinical evidence considerations. A sequential decision-making algorithm was developed to determine when a randomized controlled trial (RCT) should be conducted to evaluate new therapeutic devices and when alternative methods can be used.

ANNALS OF SURGERY (2022)