Effectiveness of 'Nexpowder' for Hemostatic Treatments of Nonvariceal, Upper Gastrointestinal Bleeding

Not Applicable

Completed

• Conditions: Nonvariceal Upper Gastrointestinal Bleeding
• Interventions: Device: Nexpowder (Hemostatic powder); Device: Conventional Technique

• Registration Number: NCT04124588
• Lead Sponsor: Next Biomedical Co., Ltd.

Brief Summary

A prospective, multi-center, randomized controlled trial to evaluate safety and effectiveness of endoscopic hemostatic powder, 'Nexpowder' for hemostatic treatments of nonvariceal upper gastrointestinal bleeding.

This study is a prospective, multi-center, single blind (for patients), controlled investigation planned to evaluate safety and effectiveness of Nexpowder with 352 subject patients.

Detailed Description

This investigational study is designed to compare effectiveness of using the standard-of-care hemostatic therapy only, versus the standard-of-care hemostatic therapy plus an additional hemostatic treatment using Nexpower for patients with nonvariceal, upper gastrointestinal bleeding from ulcers with high-risk stigmata (Forrest classification Ia, Ib, or IIa).

The primary end-points will be evaluated by assessing the rates of re-bleeding, which occur over three (3) days following initial hemostasis achieved with the standard-of-care hemostatic therapy.

Secondary end-points consist of evaluating three items: 1) Ease of use of Nexpowder applied for the test group after reaching initial hemostasis, 2) Nexpowder device malfunction and 3) safety follow-up to check occurrence of adverse event(s)/re-bleeding at 30-day (+5) time point.

Only the subjects whose initial hemostasis has been achieved will be registered for this investigation but those who initial hemostasis has failed to be reached with the standard-of-care therapie(s) shall not be registered for this investigation.

Study Timeline

• Study Start: 2018-11-01
• Study First Submitted: 2019-10-09
• Study First Submitted QC: 2019-10-10
• Study First Posted: 2019-10-11
• Primary Completion: 2021-10-12
• Study Completion: 2021-11-11
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-25
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 348

Inclusion Criteria

• Adult male or female with age of older than 19 years.
• Patients showing non-variceal upper GI bleeding symptoms
• An endoscopic examination indicates that the patients's ulcer is categorized Class Ia, Ib, or IIa according to the Forrest Classifications.

Exclusion Criteria

• Pregnant or breast-feeding patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test group	Conventional Technique	"After" achieving initial hemostasis only with the standard-of-care, endoscopic hemostatic therapie(s)
Test group	Nexpowder (Hemostatic powder)	"After" achieving initial hemostasis only with the standard-of-care, endoscopic hemostatic therapie(s)
Control gruop	Conventional Technique	"After" achieving initial hemostasis only with the standard-of-care, Wrap up the first endoscopy without adding an additional procedure.

Primary Outcome Measures

Name	Time	Method
The rates of re-bleeding	3 days	Assessing the rates of re-bleeding, which occur over three (3) days following initial hemostasis achieved with the standard-of-care hemostatic therapy.

Secondary Outcome Measures

Name	Time	Method
Incidence of Treatment-Adverse Events & Long term Re-bleeding	30 days (+5)	Safety follow-up to check occurrence of adverse event(s)/re-bleeding.

Trial Locations

Locations (3)

Soon Chun Hyang University Bucheon Hospital; 🇰🇷 Gyeonggi-do, Korea, Republic of

Gachon Gil Hospital; 🇰🇷 Incheon, Korea, Republic of

Inha University Hospital; 🇰🇷 Incheon, Korea, Republic of