ClearEndoclip Versus EZ Clip for Upper Gastrointestinal Ulcer Bleeding

Summary

We are going to conduct a comparative study to analyze the clinical effectiveness and user convenience of EZ clips that have been used in upper gastrointestinal ulcer bleeding and newly developed clip (ClearEndoclip, FineMedix, Taegu) in Korea.

1\) Research hypothesis and purpose

* This study was designed to prove the hypothesis that the hemostatic effect of newly developed endoscopic clip (ClearEndoclip, FineMedix, Taegu, Korea) is not inferior to that of EZ clip (Olympus, Tokyo, Japan) in the treatment of hemostasis for patients who visited the upper gastrointestinal ulcer bleeding.
* This study was designed as a multi-center (9 institutions), open-labelled, randomized comparative clinical trial (1:1 ratio).

Conditions

• Peptic Ulcer Hemorrhage

Interventions

DEVICE

Endoscopic hemostasis with clip

This intervention is performed as the following orders. * The tip of endoscope is accessed to a bleeding site. * The accurate visualization of bleeding site is done. * A sheath of delivery system of clip is inserted through a working channel of endoscope. * The end of clip is opened in front of the bleeding site. If needed, clip could be rotated to adjust to a bleeding target. * The both ends of clip are placed on both sides of a bleeding site. * If bleeding is still continued, additional placements of clip are tried until bleeding stops.

Sponsors & Collaborators

• Keimyung University Dongsan Medical Center

  collaborator OTHER

• Korea University Anam Hospital

  collaborator OTHER

• National Cancer Center, Korea

  collaborator OTHER_GOV

• Nowon Eulji Medical Center

  collaborator UNKNOWN

• Pusan National University Hospital

  collaborator OTHER

• Wonju Severance Christian Hospital

  collaborator OTHER

• Inha University Hospital

  collaborator OTHER

• Presbyterian medical center

  collaborator UNKNOWN

• Ajou University School of Medicine

  lead OTHER

Principal Investigators

• Sun Gyo Lim · Department of Gastroenterology, Ajou University School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-08-24

Primary Completion

2021-07-31

Completion

2021-12-01

Countries

• South Korea

Study Locations