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

Primary Purpose

Colonic Polyps

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ClearCoajet
Sponsored by
Seoul St. Mary's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colonic Polyps

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yeouido St. Mary's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

The ClearCoajet group

The control group

Arm Description

During the endoscopic resection procedures, the ClearCoajet will be used for injection and initial hemostasis for intraprocedural bleeding.

During the endoscopic resection procedures, the conventional injector will be used for injection.

Outcomes

Primary Outcome Measures

Hemostasis of intraprocedural bleeding
Hemostasis efficacy of intraprocedural bleeding during endoscopic resection for colorectal lesions

Secondary Outcome Measures

Delayed bleeding rate
Delayed bleeding rate within 4 weeks after endoscopic resection
Complication rate
Complication rate

Full Information

First Posted
February 12, 2023
Last Updated
February 22, 2023
Sponsor
Seoul St. Mary's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05737017
Brief Title
The Efficacy and Safety of a Hybrid Hemostatic Device (ClearCoajet)
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul St. Mary's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Polyps

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The ClearCoajet group
Arm Type
Experimental
Arm Description
During the endoscopic resection procedures, the ClearCoajet will be used for injection and initial hemostasis for intraprocedural bleeding.
Arm Title
The control group
Arm Type
Active Comparator
Arm Description
During the endoscopic resection procedures, the conventional injector will be used for injection.
Intervention Type
Device
Intervention Name(s)
ClearCoajet
Intervention 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.
Primary Outcome Measure Information:
Title
Hemostasis of intraprocedural bleeding
Description
Hemostasis efficacy of intraprocedural bleeding during endoscopic resection for colorectal lesions
Time Frame
during endoscopic resection for colorectal lesions
Secondary Outcome Measure Information:
Title
Delayed bleeding rate
Description
Delayed bleeding rate within 4 weeks after endoscopic resection
Time Frame
within 4 weeks after endoscopic resection
Title
Complication rate
Description
Complication rate
Time Frame
within 4 weeks after endoscopic resection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Yeouido St. Mary's Hospital
City
Seoul
ZIP/Postal Code
07345
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Han Hee Lee, MD
Phone
82-2-2258-2083
Email
hanyee99@hanmail.net

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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