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

Not Applicable

Recruiting

• Conditions: Endoscopy; Gastrointestinal Hemorrhage; Hematemesis; With Ulcer
• Interventions: Device: Nexpowder

• Registration Number: NCT06269588
• Lead Sponsor: Changi General Hospital

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.

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-19
• Study Start: 2024-02
• Study First Submitted QC: 2024-02-13
• Last Update Submitted: 2024-02-13
• Study First Posted: 2024-02-21
• Last Update Posted: 2024-02-21
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
endoscopic hemostasis	up to 24 hours	endoscopic hemostasis success rate

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Changi General Hospital; 🇸🇬 Singapore, Singapore