Testing Nexpowder™ for treating upper gastrointestinal bleeding
A Prospective, Multi-center, Single-arm, Pilot Clinical Trial to Evaluate Efficacy and Safety of Nexpowder™ for Hemostatic Treatment of Non-variceal, Upper Gastrointestinal Bleeding
NA · Changi General Hospital · NCT06269588
This study is testing if Nexpowder™ can help stop bleeding in the upper gastrointestinal tract for people who have non-variceal upper gastrointestinal bleeding.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 21 Years to 75 Years |
| Sex | All |
| Sponsor | Changi General Hospital (other) |
| Locations | 1 site (Singapore) |
| Trial ID | NCT06269588 on ClinicalTrials.gov |
What this trial studies
This pilot clinical trial aims to evaluate the efficacy and safety of Nexpowder™ as a primary technique for achieving hemostasis in patients with non-variceal upper gastrointestinal bleeding. A total of 24 subjects will be enrolled, and their responses to the treatment will be closely monitored. The study will assess how well Nexpowder™ works in stopping bleeding during endoscopic procedures. Participants will be required to provide informed consent and comply with the study protocol.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 21 to 75 with confirmed non-variceal upper gastrointestinal bleeding.
Not a fit: Patients with uncorrected coagulation disorders or those who have received prior endoscopic treatment for the same condition may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for managing upper gastrointestinal bleeding.
How similar studies have performed: While this approach is novel in this specific context, similar studies have shown promise in using hemostatic powders for gastrointestinal bleeding.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Singapore
- Changi General Hospital — Singapore, Singapore (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gastrointestinal Hemorrhage, Hematemesis, With Ulcer, Endoscopy, gastrointestinal bleeding, hemostatic powder