NCT05737017

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

February 24, 2023

Status Verified

February 1, 2023

Enrollment Period

12 months

First QC Date

February 12, 2023

Last Update Submit

February 22, 2023

Conditions

Colonic Polyps

Outcome Measures

Primary Outcomes (1)

  • Hemostasis of intraprocedural bleeding

    Hemostasis efficacy of intraprocedural bleeding during endoscopic resection for colorectal lesions

    during endoscopic resection for colorectal lesions

Secondary Outcomes (2)

  • Delayed bleeding rate

    within 4 weeks after endoscopic resection

  • Complication rate

    within 4 weeks after endoscopic resection

Study Arms (2)

The ClearCoajet group

EXPERIMENTAL

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

Device: ClearCoajet

The control group

ACTIVE COMPARATOR

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

Device: ClearCoajet

Interventions

ClearCoajetDEVICE

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 ClearCoajet groupThe control group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pedunculated polyp
  • Patients with coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yeouido St. Mary's Hospital

Seoul, 07345, South Korea

RECRUITING

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 12, 2023

First Posted

February 21, 2023

Study Start

November 1, 2022

Primary Completion

October 31, 2023

Study Completion

December 31, 2023

Last Updated

February 24, 2023

Record last verified: 2023-02

Locations

KR(1)