Safety and Efficacy Trial for the Sentire Surgical System (C1000)
Research type
Research Study
Full title
A Pivotal Single-Arm, Single-Centre, Clinical Investigation to Evaluate the Safety and Efficacy of the Sentire Surgical System (C1000) in Robotic-Assisted Colorectal and Urological Surgery
IRAS ID
346045
Contact name
Jim S. Khan
Contact email
Sponsor organisation
Cornerstone Robotics Limited
Duration of Study in the UK
1 years, 2 months, 0 days
Research summary
WHY:
The primary purpose of this clinical investigation is to evaluate the safety and efficacy of the Sentire Surgical System (C1000) in colorectal and urological surgical procedures within the European population. The investigation is designed to expand the patient population from Asian population covered in previous investigation to European population, thereby ensuring that the system is suitable for all target populations.WHAT:
Participants in the study will undergo surgery with the new robotic system, but their treatment will not change in any way. The robot is entirely controlled by a surgeon and does not operate independently. The study will gather data on surgical outcomes and recovery to assess the performance of the new robot.WHO:
The system is indicated for adult patients with a Body Mass Index (BMI) between 18 and 35 kg/m².The Sentire Surgical System (C1000) shall be used ¬in this investigation for patients with colorectal and/or urological diseases who are deemed suitable for minimally invasive surgery.
WHERE:
The study is being conducted at Portsmouth Hospitals University NHS Trust, where the surgeries will take place using the new robotic system.HOW:
Participants will receive their scheduled surgery as planned. Afterward, the research team will collect information from medical records and conduct follow-up checks at 14 and 30 days after surgery.REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
24/YH/0255
Date of REC Opinion
19 Dec 2024
REC opinion
Further Information Favourable Opinion