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

NCT ID: NCT06269588

Last Updated: 2024-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-29

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastrointestinal Hemorrhage Hematemesis; With Ulcer Endoscopy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

prospective single arm intervention cohort
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Endoscopic hemostasis using Nexpowder

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

Group Type EXPERIMENTAL

Nexpowder

Intervention Type DEVICE

Endoscopic hemostasis

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nexpowder

Endoscopic hemostasis

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Next Biomedical Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Tan Tock Seng Hospital

OTHER

Sponsor Role collaborator

National University Hospital, Singapore

OTHER

Sponsor Role collaborator

Changi General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Changi General Hospital

Singapore, , Singapore

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Singapore

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Tiing Ang, MRCP (UK)

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NBM-NP004

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.