The Efficacy and Safety of a Hybrid Hemostatic Device (ClearCoajet)
NCT05737017 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400
Last updated 2023-02-24
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
- 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.
Sponsors & Collaborators
-
Seoul St. Mary's Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-11-01
- Primary Completion
- 2023-10-31
- Completion
- 2023-12-31
Countries
- South Korea
Study Locations
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