Clinical trial to comparatively evaluate the effectiveness and safety of absorbable internal hemostatic products used for hemostasis of oozing in patients with bleeding from upper gastrointestinal ulcers after endoscopic procedures

A prospective, single-center (subject), single-blind, randomized, confirmatory clinical trial was conducted to compare and evaluate the effectiveness and safety of absorbable internal hemostatic products used for hemostasis of oozing in patients with upper gastrointestinal ulcer bleeding due to endoscopic mucosal resection or endoscopic sub-mucosal dissection compared with 'argon plasma coagulation'

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0009129

Enrollment

Registered

2024-01-24

Start date

2017-12-13

Completion date

Unknown

Last updated

2024-03-04

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

Conditions

None listed

Interventions

Medical Device : Test group: Hemostatic pad (ES-H-01) Control group: argon plasma coagulation To evaluate hemostatic efficacy and safety in patients who developed upper gastrointestinal ulcer bleedin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 19 or older 2. Those who need or are scheduled to undergo endoscopic procedures using the EMR or ESD method to remove upper gastrointestinal lesions 3. Those showing Oozing Hemorrhage due to EMR or ESD (if applicable to Forrest classification 1b) -> At this time, anyone with findings of exudative bleeding immediately after EMR or ESD and exudative bleeding after hemostasis of major bleeding could participate in this clinical trial. 4. Those with appropriate bone marrow function (ANC = 1,500 cells/?) 5. A person who voluntarily consents to a clinical trial, is aware of the right to withdraw consent at any time without penalty, and is willing and able to comply with the trial protocol.

Exclusion criteria

Exclusion criteria: 1. If major bleeding occurs at the EMR or ESD treatment site and persists -> Major bleeding: Spurting hemorrhage (Forrest classification 1a) 2. Those who have experienced upper gastrointestinal endoscopic resection within 7 days of screening 3. Those who require or are scheduled to undergo EMR or ESD procedures more than twice 4. Those with uncorrected coagulation disorders (Prothrombin time > 3sec or Platelet count Specific reasons are stated in the case record.

Design outcomes

Primary

Measure	Time frame
Initial hemostasis rate	—

Secondary

Measure	Time frame
Rebleeding rate;Ulcer healing evaluation	—

Countries

Korea, Republic of

Contacts

Public ContactJoo Young Cho

CHA Gangnam Medical Center CHA University

cjy6695@naver.com+82-2-3468-3000

Outcome results