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

Not Applicable

Recruiting

• Conditions: Colonic Polyps
• Interventions: Device: ClearCoajet

• Registration Number: NCT05737017
• Lead Sponsor: Seoul St. Mary's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-01
• Status Verified: 2023-02
• Study First Submitted: 2023-02-12
• Study First Submitted QC: 2023-02-12
• Study First Posted: 2023-02-21
• Last Update Submitted: 2023-02-22
• Last Update Posted: 2023-02-24
• Primary Completion: 2023-10-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• patients with colorectal sessile polyps or lateral growth tumors larger than 1.5 cm

Exclusion Criteria

• Pedunculated polyp
• Patients with coagulopathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The control group	ClearCoajet	During the endoscopic resection procedures, the conventional injector will be used for injection.
The ClearCoajet group	ClearCoajet	During the endoscopic resection procedures, the ClearCoajet will be used for injection and initial hemostasis for intraprocedural bleeding.

Primary Outcome Measures

Name	Time	Method
Hemostasis of intraprocedural bleeding	during endoscopic resection for colorectal lesions	Hemostasis efficacy of intraprocedural bleeding during endoscopic resection for colorectal lesions

Secondary Outcome Measures

Name	Time	Method
Delayed bleeding rate	within 4 weeks after endoscopic resection	Delayed bleeding rate within 4 weeks after endoscopic resection
Complication rate	within 4 weeks after endoscopic resection	Complication rate

Trial Locations

Locations (1)

Yeouido St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of