CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 348 enrolled
Drug / intervention
Nexpowder (Hemostatic powder) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04124588
NCT04124588N/ACompleted

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

Next Biomedical Co., Ltd.·interventional·Posted Oct 11, 2019·Updated Feb 28, 2024

In Brief

A clinical study evaluating Nexpowder (Hemostatic powder) and Conventional Technique for Nonvariceal Upper Gastrointestinal Bleeding. Completed, enrolled 348 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSouth Korea
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedOct 11, 2019
Enrollment StartNov 1, 2018
Primary CompletionOct 12, 2021
Study CompletionNov 11, 2021
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 6.7 years ago

Interventions

Nexpowder (Hemostatic powder)device

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.

Conventional Techniquedevice

Argon Plasma Coagulation, Coagulation including Forcep, Hemoclipping, Band Ligation, Epinephrine or Absolute Alcohol Injecction can be used as standard-of-care hemostatic treatment(s).