Robotic Assisted Surgical Devices
Coordinated Registry Network
Use of robotic systems for minimally invasive surgery has rapidly increased during the last decade. Intuitive surgical reports indicate that over a million robotic procedures are performed in the United States across various surgical specialties. A robotic surgery registry is being developed to systematically collect device-related and process-related real-time data. The U.S. FDA/CDRH has identified this as a priority area for evidence development and helped develop a collaborative effort. Development of this registry has a potential to support pre-market regulatory decision-making, to streamline the development of innovative products in patient care, as well to establish monitoring and safety innovation of RASD.
A landmark RASD Registry consensus conference was convened by the Institute of Surgical Excellence (ISE) in September 2016, which brought together 44 key opinion leaders through a public – private partnership to determine the minimal data set that would be needed for a RASD Registry. The participants included robotic surgery experts, registry experts, government representatives, and society representatives. Through the consensus conference discussions and two additional post-conference Delphi surveys completed by meeting participants, a minimal intraoperative and operative room staff experience data set was agreed upon that will be included in the RASD Registry. In an update meeting in 2019, it was agreed upon to utilize procedures related to gynecologic cancers in the pilot study since there is some controversy regarding the efficacy of minimally invasive procedures for the treatment of these cancers.
The RASD CRN’s main objective is to design, develop, and successfully implement a real-world data robotic surgery data registry that systematically collects in near real-time device-related and process-related data, is interoperable with clinical databases, and utilizes those data to improve device safety, surgeon/team performance, and public health. To further this mission, the CRN aims to conduct a six-month pilot study in three to six hospitals to test the RASD registry data set, optimize the efficiency of collecting the data, and refine data security measures. Findings from the pilot study will be incorporated into the data collection workflow and the development of a national RASD registry that is anticipated to be completed and ready for rollout in the second quarter of 2021.
RASD CRN is a collaborative effort of ISE with MDEpiNet Coordinating Center at Weill Cornell Medicine and FDA. It is led by ISE with data vendor partners such as Medstreaming/M2S.
ISE is a 501(c) (3) non-profit organization dedicated to improving surgical care and patient outcomes with a mission to support the implementation of safer solutions to complex surgical interventions and emerging technologies. ISE utilizes a systems-based approach to bring together key stakeholders to identify issues, set goals, facilitate collaboration, and develop education and training tools to assess and fill gaps in creating a change in informing healthcare consumers. ISE’s leadership includes Jeffrey Levy, Martin Martino, Nazema Siddiqui, John Porterfield, Carla Pugh, and Dimitrios Stefanidis. ISE also has an advisory board consisting of medical experts in the fields of Cardiology, Cardiothoracic, Colorectal, Neurosurgery, Neonatology, Ob/Gyn, Orthopedics, Pediatrics, Urology, and Vascular medicine. The advisory board also includes experts in non-profit organizations and law.
The registry network is supported by Jeffery Levy (ISE), Binita Ashar (FDA), Danica Marinac-Dabic (FDA), Jay Redan (University of Central Florida) and Art Sedrakyan (Weill Cornell Medicine).
There is an established MOU between MDEpiNet Coordinating Center and the CRN led by ISE. There is also an established MOU between ISE and the Society of Robotic Surgery (SRS).
RASD CRN is in the development stage and aims to collaborate with academic centers and hospitals as well as public private partners across the US to capture patient populations of various demographics and backgrounds. The patient population to be captured in the pilot study include those undergoing hysterectomy, radical hysterectomy, lymph node resection, and oophorectomy. This patient population will be expanded with the roll out of a national RASD registry following the pilot RASD registry to also include prostectomy, nephrectomy, cystectomy, colorectal resection, and lobectomy.
The data sources for the registry are EHRs, RASD data output, claims and other registry data.
Current Projects and Plans
RASD CRN is working towards identifying relevant clinical data elements, establishing core-minimum dataset for women’s health pilot RASD registry in cervical, uterine and ovarian cancer. For this initiative, ISE plans to develop society partnerships based on the current partnership with the SRS for registry participation and dissemination. Anticipated society partners for the pilot study are women’s health societies such as the American College of Obstetricians and Gynecologists (ACOG), Society of Gynecologic Oncology, and the American Association of Gynecologic Laparoscopists.
The CRN is finalizing contractual agreements with technology/industry partners to develop and manage the registry, as well as expanding the steering committee to include all major stakeholders. It is also working on finalizing hospital systems to participate in a pilot study. RASD CRN is also exploring fundraising opportunities from its partners and RASD manufacturers. The CRN’s goal is to conduct the pilot studies in 2020 and disseminate the results with plans to pilot and roll out the national registry by 2021.
Claims based robotics research projects are focusing on evaluations of the adoption and comparative effectiveness. Prostatectomy, thoracic and colo-rectal surgery outcomes studies have been completed. There is ongoing study to determine outcomes after robot-assisted versus open cystectomy for bladder cancer.