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

A Prospective, Multicenter, Randomized Controlled Trial to Evaluate Safety and Effectiveness of Endoscopic Hemostactic Powder, 'Nexpowder' for Hemostatic Treatments of Nonvariceal, Upper Gastrointestinal Bleeding

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.

Study Overview

• Status: Completed
• Conditions: Nonvariceal Upper Gastrointestinal Bleeding
• Intervention / Treatment: Device: Nexpowder (Hemostatic powder); Device: Conventional Technique

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 Type: Interventional
• Enrollment (Actual): 348
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do, Korea, Republic of, 14584
    • Soon Chun Hyang University Bucheon Hospital
  • Incheon, Korea, Republic of, 22332
    • Inha University Hospital
  • Incheon, Korea, Republic of, 21565
    • Gachon Gil Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test group; "After" achieving initial hemostasis only with the standard-of-care, endoscopic hemostatic therapie(s)	Device: Nexpowder (Hemostatic powder); Nexpowder generates gelation-effects when the powder comes into contact with water, forms a physical barrier to control hemorrhage, preserve ulcer sites and thereby demonstrates its effective hemostatic performance. Hydrogels, which turned into gel-formation through water contacts in the gastrointestinal tract protect the wound sites for over 24 hours, are subsequently detached from the lesion, and completely excreted from the patient body system within 3 days.; Device: Conventional Technique; Argon Plasma Coagulation, Coagulation including Forcep, Hemoclipping, Band Ligation, Epinephrine or Absolute Alcohol Injecction can be used as standard-of-care hemostatic treatment(s).
Active Comparator: Control gruop; "After" achieving initial hemostasis only with the standard-of-care, Wrap up the first endoscopy without adding an additional procedure.	Device: Conventional Technique; Argon Plasma Coagulation, Coagulation including Forcep, Hemoclipping, Band Ligation, Epinephrine or Absolute Alcohol Injecction can be used as standard-of-care hemostatic treatment(s).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Next Biomedical Co., Ltd.
• Investigators: Study Director: Eunhye Lee, Ph.D, NEXTBIOMEDICAL CO., LTD.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): October 12, 2021
• Study Completion (Actual): November 11, 2021

Study Registration Dates

• First Submitted: October 9, 2019
• First Submitted That Met QC Criteria: October 10, 2019
• First Posted (Actual): October 11, 2019

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 25, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Hemorrhage; Gastrointestinal Hemorrhage; Coagulants; Hemostatics
• Other Study ID Numbers: NEXTBIO-632-EWD3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No