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

C

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

  • 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

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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