NCT05737017

The Efficacy and Safety of a Hybrid Hemostatic Device (ClearCoajet)

A Randomized Active-controlled Clinical Trial to Investigate the Efficacy and Safety of a Hybrid Hemostatic Device (ClearCoajet) During Endoscopic Resection for Colorectal Tumors

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Seoul St. Mary's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The ClearCoajet is a new hemostasis device with a hybrid function (Coagulation + Injection) and is developed to provide effective coagulation, injection, and marking around lesions without changing devices during the endoscopic procedure. In this study, the investigators examine the hemostatic effect of ClearCoajet on intraprocedural bleeding during endoscopic mucosal resection or endoscopic submucosal dissection for colorectal sessile polyps or lateral growth tumors larger than 1.5 cm. The investigators also aim to compare the delayed bleeding and recurrence rates between the ClearCoajet group and the control group.

Conditions

• Colonic Polyps

Interventions

Type	Name	Description
DEVICE	ClearCoajet	The ClearCoajet is a new hemostasis device with a hybrid function (Coagulation + Injection) and is developed to provide effective coagulation, injection, and marking around lesions without changing devices during the endoscopic procedure.

Timeline

• Start date: 2022-11-01
• Primary completion: 2023-10-31
• Completion: 2023-12-31
• First posted: 2023-02-21
• Last updated: 2023-02-24

Locations

1 site across 1 country: South Korea