ClearEndoclip Versus EZ Clip for Upper Gastrointestinal Ulcer Bleeding

NCT04536428 | Unknown DMC

• 1 other identifier: AJIRB-DEV-DE2-20-148
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

peptic ulcer; hemorrhage; stomach; duodenum

Outcome Measures

Primary Outcomes (1)

• Rebleeding rate after endoscopic hemostasis

  The rate of rebleeding at the site of bleeding within 7 days after the first endoscopic hemostasis, which should be identified endoscopically.

  upto 7 days

Secondary Outcomes (2)

• Satisfaction scores of the operator and the assistant

  during endoscopic procedure

• Failure rate of clip installation

  during endoscopic procedure

Study Arms (2)

ClearEndoclip

EXPERIMENTAL

This arm is a group in whom ClearEndoclip would be used for the treatment of bleeding.

Device: Endoscopic hemostasis with clip

EZ clip

ACTIVE COMPARATOR

This arm is a group in whom EZ clip would be used for the treatment of bleeding.

Device: Endoscopic hemostasis with clip

Interventions

Endoscopic hemostasis with clip DEVICE

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.

ClearEndoclip; EZ clip

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged 20 to 80
• The patients who came to the emergency room due to upper gastrointestinal bleeding with as follows: peptic ulcer with acute bleeding or protruding vascular exposure (Forrest class Ia-IIa), anastomotic vascular ulcer bleeding, bleeding from endoscopic submucosal dissection or endoscopic mucosal resection site after 24 hours
• American Society of Anesthesiologist (ASA) Physical Status 1 - 3
• Patients with adequate patient compliance and adequate geographical distance for follow-up. character

You may not qualify if:

• Patients with gastrointestinal bleeding who are not recommended to clip Bleeding from a malignant tumor Hemorrhagic gastritis Angiodysplasia variceal bleeding
• Bleeding during endoscopic submucosal dissection or endoscopic mucosal resection
• Patients with insufficient clinical information
• Pregnant or lactating patients
• Patients or guardians who have not obtained informed consent

Sponsors & Collaborators

• Ajou University School of Medicine: lead
• Keimyung University Dongsan Medical Center: collaborator
• Korea University Anam Hospital: collaborator
• National Cancer Center, Korea: collaborator
• Nowon Eulji Medical Center: collaborator
• Pusan National University Hospital: collaborator
• Wonju Severance Christian Hospital: collaborator
• Inha University Hospital: collaborator
• Presbyterian medical center: collaborator

Study Sites (1)

Sun Gyo Lim

Suwon, Gyeonggi-do, 16499, South Korea

Location

MeSH Terms

Conditions

Peptic Ulcer Hemorrhage; Peptic Ulcer; Hemorrhage

Interventions

Hemostasis, Endoscopic; Surgical Instruments

Condition Hierarchy (Ancestors)

Gastrointestinal Hemorrhage; Gastrointestinal Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Duodenal Diseases; Intestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Hemostatic Techniques; Therapeutics; Surgical Equipment; Equipment and Supplies

Study Officials

• Sun Gyo Lim

  Department of Gastroenterology, Ajou University School of Medicine

  PRINCIPAL INVESTIGATOR

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: August 6, 2020
• First Posted: September 2, 2020
• Study Start: August 24, 2020
• Primary Completion: July 31, 2021
• Study Completion: December 1, 2021
• Last Updated: September 2, 2020

Record last verified: 2020-08

Locations

KR (1)