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Trial Title:
The Efficacy and Safety of a Hybrid Hemostatic Device (ClearCoajet)
NCT ID:
NCT05737017
Condition:
Colonic Polyps
Conditions: Official terms:
Colonic Polyps
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
ClearCoajet
Description:
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.
Arm group label:
The ClearCoajet group
Arm group label:
The control group
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- patients with colorectal sessile polyps or lateral growth tumors larger than 1.5 cm
Exclusion Criteria:
- Pedunculated polyp
- Patients with coagulopathy
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Yeouido St. Mary's Hospital
Address:
City:
Seoul
Zip:
07345
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Han Hee Lee, MD
Phone:
82-2-2258-2083
Email:
hanyee99@hanmail.net
Start date:
November 1, 2022
Completion date:
December 31, 2023
Lead sponsor:
Agency:
Seoul St. Mary's Hospital
Agency class:
Other
Source:
Seoul St. Mary's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05737017
