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

A Prospective, Multi-center, Single-arm, Pilot Clinical Trial to Evaluate Efficacy and Safety of Nexpowder™ for Hemostatic Treatment of Non-variceal, Upper Gastrointestinal Bleeding

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

Study Overview

• Status: Recruiting
• Conditions: Endoscopy; Gastrointestinal Hemorrhage; Hematemesis; With Ulcer
• Intervention / Treatment: Device: Nexpowder

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 529889
    • Recruiting
    • Changi General Hospital
    • Contact: Tiing Ang, MRCP (UK); Phone Number: 69365737; Email: ang.tiing.leong@singhealth.com.sg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 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 body within 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 trials that could affect the results of the study
7. Other cases in which participation in the study is judged inappropriate by the investigators

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endoscopic hemostasis using Nexpowder; Subjects with non variceal upper GI bleeding will undergo nndoscopic hemostasis using Nexpowder as primary treatment	Device: Nexpowder; Endoscopic hemostasis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
endoscopic hemostasis	endoscopic hemostasis success rate	up to 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
recurrent bleeding rate on second-look endoscopy	recurrent bleeding rate on second-look endoscopy	24 hours
hydrogel persistence rate at the bleeding site	hydrogel persistence rate at the bleeding site	24 hours
Recurrent bleeding within 30 days after endoscopic therapy	Recurrent bleeding within 30 days after endoscopic therapy	30 days

Collaborators and Investigators

• Sponsor: Changi General Hospital
• Collaborators: National University Hospital, Singapore; Tan Tock Seng Hospital; Next Biomedical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: October 19, 2023
• First Submitted That Met QC Criteria: February 13, 2024
• First Posted (Estimated): February 21, 2024

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: gastrointestinal bleeding; hemostatic powder
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Vomiting; Hemorrhage; Gastrointestinal Hemorrhage; Hematemesis
• Other Study ID Numbers: NBM-NP004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No