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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05737017
Enrollment
400
Registered
2023-02-21
Start date
2022-11-01
Completion date
2023-12-31
Last updated
2023-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonic Polyps

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.

Interventions

DEVICEClearCoajet

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.

Sponsors

Seoul St. Mary's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Pedunculated polyp * Patients with coagulopathy

Design outcomes

Primary

MeasureTime frameDescription
Hemostasis of intraprocedural bleedingduring endoscopic resection for colorectal lesionsHemostasis efficacy of intraprocedural bleeding during endoscopic resection for colorectal lesions

Secondary

MeasureTime frameDescription
Delayed bleeding ratewithin 4 weeks after endoscopic resectionDelayed bleeding rate within 4 weeks after endoscopic resection
Complication ratewithin 4 weeks after endoscopic resectionComplication rate

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026