New robotic platform for transoral robotic surgery: an IDEAL stage 0 study.

Objectives: This study aims to assess the feasibility to perform transoral robotic surgery (TORS) with a new robotic platform, the Versius Surgical System (CMR Surgical, UK) in a preclinical cadaveric setting in accordance to stage 0 of the IDEAL-D framework.

Design: IDEAL stage 0 preclinical assessment of the Versius Robotic System in TORS in human cadavers.

Setting: All procedures were performed in a simulated operating theatre environment at a UK surgical training centre.

Competency assessment for the Versius surgical robot: a validity investigation study of a virtual reality simulator-based test.

Background: When introducing new equipment like robotic surgical systems, it is essential to ensure that surgeons have the basic skills before operating on patients. The objective was to investigate the validity evidence for a competency-based test for basic robotic surgical skills using the Versius® trainer.

Methods: We recruited medical students, residents, and surgeons which were classified based on data on clinical experience with the Versius system as either novices (0 min), intermediates (1-1000 min), or experienced (> 1000 min).

Discovery and In Vitro Characterization of BAY 2686013, an Allosteric Small Molecule Antagonist of the Human Pituitary Adenylate Cyclase-Activating Polypeptide Receptor.

The human pituitary adenylate cyclase-activating polypeptide receptor (hPAC-R), a class B G-protein-coupled receptor (GPCR) identified almost 30 years ago, represents an important pharmacological target in the areas of neuroscience, oncology, and immunology. Despite interest in this target, only a very limited number of small molecule modulators have been reported for this receptor. We herein describe the results of a drug discovery program aiming for the identification of a potent and selective hPAC-R antagonist.

Preclinical evaluation of the Versius surgical system: A next-generation surgical robot for use in minimal access prostate surgery.

Objectives: To evaluate the Versius surgical system for robot-assisted prostatectomy in a preclinical cadaveric model using varying system setups and collect surgeon feedback on the performance of the system and instruments, in line with IDEAL-D recommendations.

Materials And Methods: Procedures were performed in cadaveric specimens by consultant urological surgeons to evaluate system performance in completing the surgical steps required for a prostatectomy. Procedures were conducted using either a 3-arm or 4-arm bedside unit (BSU) setup.

Safe Implementation of a Next-Generation Surgical Robot: First Analysis of 2,083 Cases in the Versius Surgical Registry.

Objective: To present the first report of data from the Versius Surgical Registry, a prospective, multicenter data registry with ongoing collection across numerous surgical indications, developed to accompany the Versius Robotic Surgical System into clinical practice.

Background: A data registry can be utilized to minimize risk to patients by establishing the safety and effectiveness of innovative medical devices and generating a thorough evidence base of real-world data.

Methods: Surgical outcome data were collected and inputted through a secure online platform.

Safe implementation of surgical innovation: a prospective registry of the Versius Robotic Surgical System.

Objectives: To describe a new, international, prospective surgical registry developed to accompany the clinical implementation of the Versius Robotic Surgical System by accumulating real-world evidence of its safety and effectiveness.

Interventions: This robotic surgical system was introduced in 2019 for its first live-human case. With its introduction, cumulative database enrollment was initiated across several surgical specialties, with systematic data collection via a secure online platform.

Monofilament suture versus braided suture thread to improve pregnancy outcomes after vaginal cervical cerclage (C-STICH): a pragmatic randomised, controlled, phase 3, superiority trial.

Background: Miscarriage in the second trimester and preterm birth are significant global problems. Vaginal cervical cerclage is performed to prevent pregnancy loss and preterm birth. We aimed to determine the effectiveness of a monofilament suture thread compared with braided suture thread on pregnancy loss rates in women undergoing a cervical cerclage.

Early evaluation of a next-generation surgical system in robot-assisted total laparoscopic hysterectomy: A prospective clinical cohort study.

Introduction: This study aimed to demonstrate the safe and effective use of the Versius surgical system (CMR Surgical, Cambridge, UK) in robot-assisted total laparoscopic hysterectomy. This surgical robot was developed iteratively with input from surgeons to improve surgical outcomes and end-user experience. We report data from the gynecology cohort of an early clinical trial designed in broad alignment with IDEAL-D (Idea, Development, Exploration, Assessment, Long-term follow-up - Devices) stage 2b (Exploration).

A Delphi consensus statement for digital surgery.

The use of digital technology is increasing rapidly across surgical specialities, yet there is no consensus for the term 'digital surgery'. This is critical as digital health technologies present technical, governance, and legal challenges which are unique to the surgeon and surgical patient. We aim to define the term digital surgery and the ethical issues surrounding its clinical application, and to identify barriers and research goals for future practice.

The Role of the Versius Surgical Robotic System in the Paediatric Population.

The uptake of robot-assisted surgery has continuously grown since its advent in the 1990s. While robot-assisted surgery is well-established in adult surgery, the rate of uptake in paediatric surgical centres has been slower. The advantages of a robot-assisted system, such as improved visibility, dexterity, and ergonomics, could make it a superior choice over the traditional laparoscopic approach.

Preclinical evaluation of Versius, an innovative device for use in robot-assisted thoracic surgery.

Objectives: The adoption of robot-assisted thoracic surgery (RATS) has helped to overcome some of the challenges associated with surgeons performing conventional video-assisted thoracic surgery. The Versius Surgical System (CMR Surgical, Cambridge, UK) has been developed iteratively in line with surgical team feedback to improve the surgeon's experience and patient outcomes. The goal of this study was to assess the use of the device in RATS in a preclinical setting and to fulfil Idea, Development, Exploration, Assessment, Long-Term Follow Up-Devices stage 1 (Idea).

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

Objective: The aim of this study was to demonstrate the ability of the Versius Surgical System to successfully and safely complete cholecystectomy.

Background: The system has been developed in-line with surgeon feedback to overcome limitations of conventional laparoscopy to enhance surgeon experience and patient outcomes. Here we present results from the cholecystectomy cohort from a completed early clinical trial, which was designed to broadly align with Stage 2b of the Idea, Development, Exploration, Assessment, Long-term follow-up framework for surgical innovation.

Utilising an Accelerated Delphi Process to Develop Guidance and Protocols for Telepresence Applications in Remote Robotic Surgery Training.

Context: The role of robot-assisted surgery continues to expand at a time when trainers and proctors have travel restrictions during the coronavirus disease 2019 (COVID-19) pandemic.

Objective: To provide guidance on setting up and running an optimised telementoring service that can be integrated into current validated curricula. We define a standardised approach to training candidates in skill acquisition via telepresence technologies.

Evolving robotic surgery training and improving patient safety, with the integration of novel technologies.

Introduction: Robot-assisted surgery is becoming increasingly adopted by multiple surgical specialties. There is evidence of inherent risks of utilising new technologies that are unfamiliar early in the learning curve. The development of standardised and validated training programmes is crucial to deliver safe introduction.

Interim safety analysis of the first-in-human clinical trial of the Versius surgical system, a new robot-assisted device for use in minimal access surgery.

Objective: The aim of this study was to provide an interim safety analysis of the first 30 surgical procedures performed using the Versius Surgical System.

Background: Robot-assisted laparoscopy has been developed to overcome some of the important limitations of conventional laparoscopy. The new system is currently undergoing a first-in-human prospective clinical trial to confirm the safety and effectiveness of the device when performing minimal access surgery (MAS).

Usability assessment of Versius, a new robot-assisted surgical device for use in minimal access surgery.

Objectives: Versius is a teleoperated surgical robotic system intended for use in minimal access surgery. This study aimed to validate the safety and effectiveness of the Versius user interface in the hands of trained users and identify and address the causes of any user errors.

Design: Surgical teams completed a commercially representative training program over 3.

Preclinical evaluation of the versius surgical system, a new robot-assisted surgical device for use in minimal access general and colorectal procedures.

Objective: To evaluate the utility of a new robot-assisted surgical system (the Versius Surgical System, CMR Surgical, Cambridge, UK) for use in minimal access general and colorectal surgery, in a preclinical setting. Robot-assisted laparoscopy has been developed to overcome some of the important limitations of conventional laparoscopy. The new system is designed to assist surgeons in performing minimal access surgery and overcome some of the challenges associated with currently available surgical robots.

Preclinical Evaluation of the Versius Surgical System, a New Robot-assisted Surgical Device for Use in Minimal Access Renal and Prostate Surgery.

Background: Minimal access surgery (MAS) is well-established in urological surgery. However, MAS is technically demanding and associated with a prolonged learning curve. Robot-assisted laparoscopy has made progress in overcoming these challenges.

Using end-user feedback to optimize the design of the Versius Surgical System, a new robot-assisted device for use in minimal access surgery.

Background: Robot-assisted minimal access surgery (MAS) reduces blood loss, recovery time, intraoperative and postoperative complications and pain. However, uptake of robotic MAS remains low, suggesting there are barriers to its use. To overcome these barriers, a new surgical robot system, Versius, was developed based on the needs and feedback of surgeons and surgical teams.

The impact of pelvic floor multidisciplinary team on patient management: the experience of a tertiary unit.

Purpose: Pelvic floor dysfunction is a common and heterogenous condition with numerous clinical manifestations, making the optimal management challenging. The traditional single-specialty approach may fail to address its complex nature. Currently, there are no published data on the impact of joint pelvic floor multidisciplinary team (MDT) meetings on patient management.

Responsibility toward affordable healthcare: disposable versus reusable methods for pelvic floor repair.

Background: The adverse publicity surrounding the use of mesh for correction of pelvic organ prolapse has driven a renewed interest in native tissue repair. Established techniques used reusable instruments, while recent innovations have generally involved disposable equipment. Here, we compare outcomes between the two techniques used for sacrospinous ligament fixation for the correction of apical prolapse: Miya Hook (reusable) and Capio (single-use) suturing devices.

Comparison of the effectiveness of repeated injections of onabotulinum toxin A for refractory idiopathic detrusor overactivity: analysis of an open label extension of a randomized trial (the RELAX study).

Aims: To assess effects of repeat treatment with onabotulinumtoxin A (onaBoNT-A) in women with refractory idiopathic detrusor overactivity (DO).

Methods: Analysis of an open-label extension study of a large randomized placebo controlled trial of onaBoNT-A. Participants had been randomized to receive 200 IU onaBoNTA or placebo and were offered up to two further onaBoNTA injections over a 5-year period.

Relationship between vaginal microbial dysbiosis, inflammation, and pregnancy outcomes in cervical cerclage.

Preterm birth, the leading cause of death in children under 5 years, may be caused by inflammation triggered by ascending vaginal infection. About 2 million cervical cerclages are performed annually to prevent preterm birth. The procedure is thought to provide structural support and maintain the endocervical mucus plug as a barrier to ascending infection.