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

N

Nextbiomedical

Status

Completed

Conditions

Nonvariceal Upper Gastrointestinal Bleeding

Treatments

Device: Conventional Technique
Device: Nexpowder (Hemostatic powder)

Study type

Interventional

Funder types

Industry

Identifiers

NCT04124588
NEXTBIO-632-EWD3

Details and patient eligibility

About

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.

Full 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.

Enrollment

348 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

348 participants in 2 patient groups

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

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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