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

Endoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06269588
• Other study ID #: NBM-NP004
• Status: Recruiting
• Phase: N/A
• Start date: February 2024
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Changi General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Endoscopy
• Gastrointestinal Hemorrhage
• Hematemesis
• Hemorrhage

Intervention

Device:
• Nexpowder
Endoscopic hemostasis

Locations

Country	Name	City	State
Singapore	Changi General Hospital	Singapore

Sponsors (4)

Lead Sponsor	Collaborator
Changi General Hospital	National University Hospital, Singapore, Next Biomedical Co., Ltd., Tan Tock Seng Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	endoscopic hemostasis	endoscopic hemostasis success rate	up to 24 hours
Secondary	recurrent bleeding rate on second-look endoscopy	recurrent bleeding rate on second-look endoscopy	24 hours
Secondary	hydrogel persistence rate at the bleeding site	hydrogel persistence rate at the bleeding site	24 hours
Secondary	Recurrent bleeding within 30 days after endoscopic therapy	Recurrent bleeding within 30 days after endoscopic therapy	30 days