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

NCT04124588 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 348

Last updated 2024-02-28

No results posted yet for this study

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.

Conditions

  • Nonvariceal Upper Gastrointestinal Bleeding

Interventions

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).

Sponsors & Collaborators

  • Next Biomedical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Eunhye Lee, Ph.D · NEXTBIOMEDICAL CO., LTD.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2021-10-12
Completion
2021-11-11

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04124588 on ClinicalTrials.gov