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
Verified date | February 2023 |
Source | Seoul St. Mary's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Yeouido St. Mary's Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul St. Mary's Hospital |
Korea, Republic of,
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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