Efficacy and Safety of Nexpowder™ for Non-variceal, Upper Gastrointestinal Bleeding

Last updated: February 13, 2024
Sponsor: Changi General Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vomiting

Ulcers

Hemorrhage

Treatment

Nexpowder

Clinical Study ID

NCT06269588
NBM-NP004
  • Ages 21-75
  • All Genders

Study Summary

The purpose of this pilot clinical trial is to confirm the efficacy and safety of Nexpowder™ for hemostasis in pilot cohort of patients with NVUGIB in Singapore

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Males or females aged over 21 to 75 years
  2. Patients with confirmed nonvariceal, upper gastrointestinal bleeding
  3. Patients who voluntarily agree to the clinical trial with informed consent
  4. Patients who willing and able to comply with the study protocol

Exclusion

Exclusion Criteria:

  1. Patients with an uncorrected coagulation disorder (PLT<50*109/L, INR>2)
  2. Patients who are known to be pregnant or in lactation
  3. Patients who have received another endoscopic treatment for the same part of the bodywithin the days preceding the study
  4. Patients for whom endoscopic treatment is prohibited due to comorbidity
  5. Patients for whom the 30-day follow-up period is impossible
  6. Patients who have participated within the past month in other related clinical trialsthat could affect the results of the study
  7. Other cases in which participation in the study is judged inappropriate by theinvestigators

Study Design

Total Participants: 24
Treatment Group(s): 1
Primary Treatment: Nexpowder
Phase:
Study Start date:
February 01, 2024
Estimated Completion Date:
December 31, 2024

Study Description

24 subjects with non variceal bleeding will be enrolled. The efficacy and safety of Nexpowder™ as primary technique of endoscopci hemostasis will be assessed in this pi,ot study.

Connect with a study center

  • Changi General Hospital

    Singapore, 529889
    Singapore

    Active - Recruiting

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