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

NCT ID: NCT05737017

Last Updated: 2023-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2023-12-31

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.

Detailed Description

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Conditions

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Colonic Polyps

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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The ClearCoajet group

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

Group Type EXPERIMENTAL

ClearCoajet

Intervention Type DEVICE

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.

The control group

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

Group Type ACTIVE_COMPARATOR

ClearCoajet

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul St. Mary's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Han Hee Lee

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Yeouido St. Mary's Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Facility Contacts

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Han Hee Lee, MD

Role: primary

82-2-2258-2083

Other Identifiers

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Coajet_LGI

Identifier Type: -

Identifier Source: org_study_id

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