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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06269588

Enrollment

Registered

2024-02-21

Start date

2024-02-29

Completion date

2024-12-31

Last updated

2024-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endoscopy, Gastrointestinal Hemorrhage, Hematemesis; With Ulcer

Keywords

gastrointestinal bleeding; hemostatic powder

Brief 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

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.

Interventions

DEVICENexpowder

Endoscopic hemostasis

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

prospective single arm intervention cohort

Eligibility

Sex/Gender

ALL

Age

21 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
endoscopic hemostasis	up to 24 hours	endoscopic hemostasis success rate

Secondary

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

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026