NCT04886609

ORISE Study: Evaluation of Novel Injecting Solution (ORISE) During Endoscopic Resection of Colorectal Polyps.

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 133 (actual)
• Sponsor: Portsmouth Hospitals NHS Trust · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Is ORISE Gel an effective and feasible submucosal injecting solution during endoscopic resection of large colorectal polyps.

Detailed description

Endoscopic resection of large colonic polyps is preferred over Surgical resections due to lower morbidity and preservation of the colon and its functions. The use of submucosal injection is essential for a successful resection (EMR/ ESD). Injection of fluid into the submucosa cushions and isolates the tissue just before capture of the target lesion with a snare, thereby reducing thermal injury and the risk of perforation during EMR. ESD requires a long period of submucosal dissection and that involves multiple injections to maintain the submucosal cushion; without which the risk of perforation increases. A mixture of normal saline solution + epinephrine and blue dye like indigo carmine is the commonly used injecting solution. However, Saline dissipates very quickly leading to frequent and multiple injections. This leads to longer procedure time. Studies have demonstrated long-lasting effects of colloids when injected in the submucosal space. ORISE gel is a newly licensed injecting solution which contains a poloxamer agent leading to longer lasting submucosal cushion effect. Multicentre prospective observational cohort study Primary Objective : Primary Objective To evaluate the technical feasibility, effectiveness \& safety of the ORISE gel as an injecting solution on its own during endoscopic resection of colorectal polyps (ability to start and finish the resection with ORISE). Secondary Objective : To identify Polyp Resection Time (PRT) and the amount of ORISE gel used during resection of large colorectal polyps.

Conditions

• Colorectal Polyp

Interventions

Type	Name	Description
DEVICE	ORISE gel	To establish if ORISE Gel an effective and feasible submucosal injecting solution during endoscopic resection of large colorectal polyps

Timeline

• Start date: 2021-03-25
• Primary completion: 2023-01-12
• Completion: 2023-01-12
• First posted: 2021-05-14
• Last updated: 2024-11-14

Locations

5 sites across 2 countries: Italy, United Kingdom