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

Changi General Hospital

Status: Enrolling

Conditions: Gastrointestinal Hemorrhage; Hematemesis; With Ulcer; Endoscopy

Treatments: Device: Nexpowder

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06269588

NBM-NP004

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Endoscopic hemostasis using Nexpowder

Experimental group

Description:

Subjects with non variceal upper GI bleeding will undergo nndoscopic hemostasis using Nexpowder as primary treatment

Treatment:

Device: Nexpowder