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

Study Overview
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Brief Summary
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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.

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

Conditions
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Colonic Polyps

Intervention / Treatment
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* Device: ClearCoajet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with colorectal sessile polyps or lateral growth tumors larger than 1.5 cm Exclusion Criteria: Pedunculated polyp Patients with coagulopathy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The ClearCoajet group<br>During the endoscopic resection procedures, the ClearCoajet will be used for injection and initial hemostasis for intraprocedural bleeding. | Device: ClearCoajet<br>* 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.<br>|
| Active Comparator: The control group<br>During the endoscopic resection procedures, the conventional injector will be used for injection. | Device: ClearCoajet<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemostasis of intraprocedural bleeding | Hemostasis efficacy of intraprocedural bleeding during endoscopic resection for colorectal lesions | during endoscopic resection for colorectal lesions | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delayed bleeding rate | Delayed bleeding rate within 4 weeks after endoscopic resection | within 4 weeks after endoscopic resection | 
| Complication rate | Complication rate | within 4 weeks after endoscopic resection |