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

February 22, 2023 updated by: Han Hee Lee, Seoul St. Mary's Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with colorectal sessile polyps or lateral growth tumors larger than 1.5 cm

Exclusion Criteria:

  • Pedunculated polyp
  • Patients with coagulopathy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemostasis of intraprocedural bleeding
Time Frame: during endoscopic resection for colorectal lesions
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
Time Frame: within 4 weeks after endoscopic resection
Delayed bleeding rate within 4 weeks after endoscopic resection
within 4 weeks after endoscopic resection
Complication rate
Time Frame: within 4 weeks after endoscopic resection
Complication rate
within 4 weeks after endoscopic resection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul St. Mary's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Anticipated)

October 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

February 12, 2023

First Submitted That Met QC Criteria

February 12, 2023

First Posted (Actual)

February 21, 2023

Study Record Updates

Last Update Posted (Actual)

February 24, 2023

Last Update Submitted That Met QC Criteria

February 22, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Coajet_LGI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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