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

NCT04124588 | Completed DMC

• 1 other identifier: NEXTBIO-632-EWD3
• Study Type: interventional
• Target: 348
• Locations: 1 country
• Sites: 3

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.

Conditions

Nonvariceal Upper Gastrointestinal Bleeding

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence of Treatment-Adverse Events & Long term Re-bleeding

  30 days (+5)

Study Arms (2)

Test group

EXPERIMENTAL

"After" achieving initial hemostasis only with the standard-of-care, endoscopic hemostatic therapie(s)

Device: Nexpowder (Hemostatic powder); Device: Conventional Technique

Control gruop

ACTIVE COMPARATOR

"After" achieving initial hemostasis only with the standard-of-care, Wrap up the first endoscopy without adding an additional procedure.

Device: Conventional Technique

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.

Test group

Conventional Technique DEVICE

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

Control gruop; Test group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant or breast-feeding patients

Sponsors & Collaborators

• Next Biomedical Co., Ltd.: lead

Study Sites (3)

Soon Chun Hyang University Bucheon Hospital

Gyeonggi-do, 14584, South Korea

Location

Gachon Gil Hospital

Incheon, 21565, South Korea

Location

Inha University Hospital

Incheon, 22332, South Korea

Location

Related Publications (1)

• Shin J, Cha B, Hong J, Kwon KS, Lee E, Maeng JH, Chung JW, Park DK, Kim YJ, Kwon KA, Kim JH, Seo KS, Hong SJ, Kim KO. Prevention of rebleeding after primary haemostasis using haemostatic powder in non-variceal upper gastrointestinal bleeding: a multicentre randomised controlled trial. Gut. 2025 Oct 8;74(11):1821-1827. doi: 10.1136/gutjnl-2024-332459.

  PMID: 40360231 DERIVED

Study Officials

• Eunhye Lee, Ph.D

  NEXTBIOMEDICAL CO., LTD.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: October 11, 2019
• Study Start: November 1, 2018
• Primary Completion: October 12, 2021
• Study Completion: November 11, 2021
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

KR (3)