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Showing 1-6 of 6 trials
NCT07405203
Gastrointestinal (GI) cancers are common and significant causes of cancer death worldwide. GI cancers grow from the mucosal layer. If pre-malignant and early cancers are removed en bloc at an early stage before they spread to lymph nodes, survival rates can be improved. Endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) were developed as minimally invasive, organ-sparing methods for removing pre-malignant and early GI cancers. While EMR is suitable for smaller lesions, ESD is typically required for larger lesions. ESD offers the advantage of a higher rate of complete, single-piece resection, which is associated with a lower risk of local recurrence compared to EMR. However, ESD is a technically complex procedure with a higher risk of complications, such as perforation and bleeding. Conventional ESD is performed using a flexible endoscope with a single instrument channel to access the GI tract. This setup presents several challenges, including difficulty in maintaining the endoscope in a stable position, limited ability to provide effective tissue traction, and frequent intraprocedural bleeding. As a result, ESD demands a high level of technical skills from surgeons. The EndoR Surgical System was developed to address these challenges, aiming to allow surgeons to operate two surgical instruments with enhanced dexterity and a broader range of motions. Both pre-clinical ex-vivo studies and in-vivo studies were conducted in the development of this surgical system. Six pre-clinical ex-vivo studies were conducted in porcine stomach between 2015 and 2023 and eleven pre-clinical in-vivo studies were conducted in live porcine models with the lesion sites at stomach, rectum and left colon between 2016 and 2024. These pre-clinical studies were conducted in LASEC-PWH, MISSC-PWH and Hybrid Operating Room of Multi-Scale Medical Robotics Center (MRC) accordingly. Based on data from the ex-vivo and in-vivo experiments, two key conclusions can be drawn: i) After several training sessions, the operator's performance became more consistent and efficient. ii) The dissection rate increased as the dissection area grew-a phenomenon not observed in conventional procedures using a single endoscope and dissection tool. From the results demonstrated from the pre-clinical studies, the EndoR Surgical System allows for greater dexterity and precision in manipulating instruments, which is particularly advantageous for larger lesions. This precision can lead to more effective dissection and reduced damage to surrounding tissues. This may also reduce the risk of complications associated with ESD. By minimizing trauma to adjacent structures, the likelihood of adverse events, such as bleeding or perforation, may be significantly lowered. Patients may experience faster recovery times, contributing to improved patients' satisfaction and outcomes. As the risk of complications decreases, endoscopic procedures like ESD could become accessible to a broader patient population. While performing ESD is generally considered safe, it still remains a technically demanding procedure with the assistance of the surgical robotic system. The use of surgical robots introduces the risk of equipment malfunctions, which can lead to complications during the procedure. Additionally, any technical issues may result in delays, potentially compromising patient safety. The attending physicians will monitor and examine the subjects as necessary and appropriate and work carefully to ensure their safety. In the event of an adverse reaction, countermeasures will be taken as appropriate, and focus will be placed on ensuring the safety of the subjects while the cause of the reaction is investigated. The objective of this study is to assess the safety and performance of the EndoR Surgical System for the treatment of patients with colorectal malignant lesions. Technical success, clinical success and any adverse events shall be recorded.
NCT06133387
The objective of this study is to evaluate the safety and effectiveness of the Endoluminal Surgical (ELS) System in subjects undergoing specified transanal endoluminal procedures in the rectum and sigmoid colon. Subjects will undergo endoscopic submucosal dissection (ESD), with or without closure at the discretion of the Investigator, of benign lesions in the rectum and sigmoid colon. The safety and effectiveness outcomes will be assessed intraoperatively and postoperatively at discharge and Days 7 and 30.
NCT06970808
The goal of this clinical trial is to compare the efficacy and the safety of a new device for cold forceps polypectomy (CFP)- a special jumbo forceps- to cold snare polypectomy (CSP) for small colorectal lesions, without adding peri- or post-procedural risks to the patient. The main questions it aims to answer are: * Does the cold forceps guarantee a complete endoscopic resection rate? * How many adverse events could the jumbo forceps reduce in comparison to CSP? * Does the lesion retrieval rate increase? * Does the polypectomy duration decrease? Participants will be randomized to one or to the other group when a polypoid or non-polypoid lesion is identified. If multiple polyps are found in the same patient, they will be removed using the same polypectomy technique. If polypectomy cannot be performed using the indicated technique, a crossover will be done according to the best practice of care principles.
NCT05942677
The development of artificial intelligence (AI) systems in the field of colorectal endoscopy is currently booming, colorectal cancer being, by its frequency and severity, a real public health problem. In terms of image analysis, AI is indeed able to perform many tasks simultaneously (lesion detection, classification, and segmentation) and to combine them. Lesion detection is thus the starting point of the whole chain to choose at the end the most appropriate treatment for the patient. Large-scale studies have demonstrated the superiority of artificial intelligence-assisted detection over the usual detection by gastroenterologists, mainly for the detection of sub-centimeter polyps. However, the investigators have shown that a recent computer-aided detection system (CADe) such as the ENDO-AID software in combination with the EVIS X1 video column (Olympus, Tokyo, Japan) may present difficulties in the detection of flat lesions such as sessile serrated lesions (SSLs) and non-granular laterally spreading tumors (LST-NGs). This represents a major challenge because in addition to their shape being difficult to identify for the human eye in practice and where AI assistance would be of great value, these rare lesions are associated with advanced histology. In addition, the investigators recently described the case of a worrisome false negative of AI-assisted colonoscopy, which failed to detect a flat adenocarcinoma in the transverse colon. Therefore, it is important to measure the false negative rate of AI detection based on the macroscopic shape of the lesion. Comparing this rate to the human endoscopist's false negatives would improve the performance of AI for this specific lesion subtype in the future.
NCT05913453
Among advanced resection techniques, endoscopic full thickness resection (EFTR) allows closure and full-thickness resection by the use of the non-exposed full thickness resection device (FTRD). The study is a retrospective analysis of technical failure occurring during colorectal full-thickness resection. Full thickness resection is a safe and effective procedure for "difficult" colorectal lesions. However, technical failure can occur and to date there is no evidence about type and clinical consequences in this setting.
NCT01431703
It exists a learning curve in using NBI with magnification to differentiating colorectal lesions.