PROSTARs v1.0
Research type
Research Study
Full title
PROSTARs Evaluation of PRuk single port TransAnal Robotic Surgical System
IRAS ID
272222
Contact name
Surbhi Gupta
Contact email
Sponsor organisation
Precision Robotics Ltd
Duration of Study in the UK
1 years, 4 months, 5 days
Research summary
The primary clinical target for the Precision Robotics UK (PRUK) robotic system will be the excision of benign tumours from within the rectum, which cannot be optimally excised by endoscopy and/or which would usually be referred for local surgical excision via a trans-anal approach.
The local excision of lesions from within the rectal lumen using surgical platforms such as the Wolf ‘Trans-anal Endoscopic Microsurgery’ system offers a more stable and reliable method for excising large benign lesions, as well as a much less invasive alternative to radical excision of the rectum from within the pelvis via anterior or abdominoperineal excision. Full-thickness local excision is accepted as a primary treatment modality for early rectal cancers and local excision in the submucosal plane for benign lesions. However, the platforms currently available for local excision have considerable limitations, which limit their use to a small number of surgeons in specialist centres.
Trans-anal surgery is a challenging procedure by using current instruments. There is lack of triangulation of instruments once they have been placed in the rectum resulting in 'clashing' of instruments inside and difficulties with adequate tissue handling/manipulation.
This study involves the use of a robotic system (PRUK robotic system) together with a specially designed port (PRUK Surgical port) and robotic arm (PRUK Lightweight Robot Arm) designed to enable endoluminal tasks to be undertaken with significantly improved consistency and precision, using advanced robotic instrumentation. Currently, the primary clinical target for the PRUK device is the excision of lesions from within the rectum through a trans-anal approach. The PRUK robotic system allows robotic bi-manual control of articulated instruments in a master-slave fashion, allowing the surgeon to operate in an environment which is ergonomic for the surgeon, with high definition three-dimensional imaging of the operating site enabling precise dissection and resection of abnormal lesions.REC name
London - Dulwich Research Ethics Committee
REC reference
21/LO/0812
Date of REC Opinion
21 Dec 2021
REC opinion
Further Information Favourable Opinion