Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05737017
Other study ID # Coajet_LGI
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2022
Est. completion date December 31, 2023

Study information

Verified date February 2023
Source Seoul St. Mary's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date December 31, 2023
Est. primary completion date October 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - patients with colorectal sessile polyps or lateral growth tumors larger than 1.5 cm Exclusion Criteria: - Pedunculated polyp - Patients with coagulopathy

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Korea, Republic of Yeouido St. Mary's Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul St. Mary's Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hemostasis of intraprocedural bleeding Hemostasis efficacy of intraprocedural bleeding during endoscopic resection for colorectal lesions during endoscopic resection for colorectal lesions
Secondary Delayed bleeding rate Delayed bleeding rate within 4 weeks after endoscopic resection within 4 weeks after endoscopic resection
Secondary Complication rate Complication rate within 4 weeks after endoscopic resection
See also
  Status Clinical Trial Phase
Completed NCT05615857 - Endocuff Enhanced Colonoscopy: Does it Improve Polyp Detection and Make Rectal Retroflexion Unnecessary N/A
Not yet recruiting NCT02865382 - Detection of Colorectal Adenoma by Optical Enhancement Technology vs. High-Definition Colonoscopy N/A
Completed NCT02529007 - Endo-cuff Assisted Vs. Standard Colonoscopy for Polyp Detection in Bowel Cancer Screening N/A
Completed NCT02245854 - Efficacy and Safety of a New Polypectomy Snare for Cold-polypectomy for Small Colorectal Polyps N/A
Completed NCT01712048 - Submucosal Injection EMR vs. Underwater EMR for Colorectal Polyps N/A
Terminated NCT01297712 - Endoscopic Assessment of Polyp Histology N/A
Active, not recruiting NCT01368289 - Australian Multicentre Colonic Endoscopic Mucosal Resection Study
Completed NCT02196649 - Clip Placement Following Endoscopic Mucosal Resection - Randomised Trial N/A
Completed NCT00997802 - Japanese National Computed Tomographic (CT) Colonography Trial N/A
Not yet recruiting NCT00996619 - Measuring the Spectrum of Tissues During Endoscopy N/A
Completed NCT00468455 - Post-Op Quality of Life After Colorectal Surgery N/A
Completed NCT00018551 - Chemoprevention With Folic Acid Phase 2
Recruiting NCT02552017 - Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities N/A
Completed NCT01979458 - Photometric Stereo Endoscopy (PSE) as a Tool for Imaging the Rectum and Colon N/A
Unknown status NCT01101672 - Trial for Single Port Versus Conventional Laparoscopic Colectomy Phase 2/Phase 3
Terminated NCT01458925 - Feasibility of Check-Cap's P1 Capsule System Screening N/A
Recruiting NCT02760381 - Acetic Acid for Optical Characterization of Colonic Polyps N/A
Withdrawn NCT04253990 - Efficacy and Safety of Precut-EMR for Resecting of Colonic Polyp N/A
Completed NCT01901510 - Panchromoendoscopy Using Oral Indigo Carmine Mixed With Polyethylene Glycol Prep Phase 1
Completed NCT01761279 - High Definition Endoscopy With i-Scan for Small Colonic Polyp Evaluation: The HiScope Study N/A