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NCT05737017 Clinical Trial

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

Colonic Polyps Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05737017
Other study ID # Coajet_LGI
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2022
Est. completion date December 31, 2023

Study information
Verified date February 2023
Source Seoul St. Mary's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 400
Est. completion date December 31, 2023
Est. primary completion date October 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Korea, Republic of Yeouido St. Mary's Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul St. Mary's Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hemostasis of intraprocedural bleeding Hemostasis efficacy of intraprocedural bleeding during endoscopic resection for colorectal lesions during endoscopic resection for colorectal lesions
Secondary Delayed bleeding rate Delayed bleeding rate within 4 weeks after endoscopic resection within 4 weeks after endoscopic resection
Secondary Complication rate Complication rate within 4 weeks after endoscopic resection
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