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

NCT06269588 | Unknown DMC

• 1 other identifier: NBM-NP004
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Gastrointestinal Hemorrhage; Hematemesis; With Ulcer; Endoscopy

Keywords

gastrointestinal bleeding; hemostatic powder

Outcome Measures

Primary Outcomes (1)

• endoscopic hemostasis

  endoscopic hemostasis success rate

  up to 24 hours

Secondary Outcomes (3)

• recurrent bleeding rate on second-look endoscopy

  24 hours

• hydrogel persistence rate at the bleeding site

  24 hours

• Recurrent bleeding within 30 days after endoscopic therapy

  30 days

Study Arms (1)

Endoscopic hemostasis using Nexpowder

EXPERIMENTAL

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

Device: Nexpowder

Interventions

Nexpowder DEVICE

Endoscopic hemostasis

Endoscopic hemostasis using Nexpowder

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females aged over 21 to 75 years
• Patients with confirmed nonvariceal, upper gastrointestinal bleeding
• Patients who voluntarily agree to the clinical trial with informed consent
• Patients who willing and able to comply with the study protocol

You may not qualify if:

• Patients with an uncorrected coagulation disorder (PLT\<50\*109/L, INR\>2)
• Patients who are known to be pregnant or in lactation
• Patients who have received another endoscopic treatment for the same part of the body within the days preceding the study
• Patients for whom endoscopic treatment is prohibited due to comorbidity
• Patients for whom the 30-day follow-up period is impossible
• Patients who have participated within the past month in other related clinical trials that could affect the results of the study
• Other cases in which participation in the study is judged inappropriate by the investigators

Sponsors & Collaborators

• Changi General Hospital: lead
• Next Biomedical Co., Ltd.: collaborator
• Tan Tock Seng Hospital: collaborator
• National University Hospital, Singapore: collaborator

Study Sites (1)

Changi General Hospital

Singapore, 529889, Singapore

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Hemorrhage; Hematemesis

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vomiting; Signs and Symptoms, Digestive; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective single arm intervention cohort

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: February 21, 2024
• Study Start: February 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 21, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)