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NOT YET RECRUITING
NCT06726798
NA

Prospective Cohort Study on the Safety and Efficacy of Endorobotics for Endoscopic Submucosal Dissection (Endorobotics ESD)

Sponsor: Chinese University of Hong Kong

View on ClinicalTrials.gov

Summary

This trial is a prospective, single arm study of 30 patients recruited to undergo endoscopic submucosal dissection (ESD) with a novel robotic assisted technology. It will assess the safety and performance of robotic-assisted endoscopic submucosal dissection (ESD) of superficial gastric and colorectal lesions that otherwise cannot be optimally and radically removed by snare-based techniques. The primary outcome of the study is rate of complete (R0) resection of the neoplasia.

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2024-12-09

Completion Date

2025-07-30

Last Updated

2024-12-10

Healthy Volunteers

No

Interventions

PROCEDURE

Endoscopic submucosal dissection with EndoRobotics traction device

All patients received robotic ESD under general anesthesia or monitored anaesthetic care at the endoscopy center of Prince of Wales Hospital. The targeted lesion would first be localized and pre-injected using a mixture of normal saline, indigocarmine, epinephrine and sodium hyaluronate. The robotic endoscopic traction device was then inserted to reach the target. Mucosal incision first started from the anal side followed by lifting with the grasper\[Figure 1; Video 1\]. Vio 3 diathermy system (ERBE, Germany) was used with endocut Q effect 3 and forced coagulation effect 3. Further submucosal dissection would be performed by electrocautery knife with traction achieved via EndoRobotics traction. Upon completion, the specimen would be retrieved upon withdrawal of the whole system.

Locations (1)

Prince of Wales Hospital

Hong Kong, Hong Kong