Effectiveness and Safety of Nexpowder as an Endoscopic Hemostatic Treatment
A Prospective, Multicenter, Open-label, Randomized Controlled Study to Evaluate Safety and Effectiveness of Endoscopic Hemostatic Powder, 'Nexpowder' for Hemostatic Treatments of Lower Gastrointestinal Bleeding After Colon Polypectomy
1 other identifier
interventional
66
1 country
3
Brief Summary
In patients who show signs of bleeding and bleeding after polypectomy such as EMR and ESD for polyps with a diameter of 2 cm or more in the lower gastrointestinal tract, the effectiveness and safety of Nexpowder as an endoscopic hemostatic treatment are confirmed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2022
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 18, 2022
CompletedFirst Submitted
Initial submission to the registry
May 8, 2023
CompletedFirst Posted
Study publicly available on registry
June 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 29, 2023
CompletedFebruary 23, 2024
February 1, 2024
1.1 years
May 8, 2023
February 21, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Rate of rebleeding within 7 days of successful endoscopic hemostasis
Rate of rebleeding within 7 days of successful endoscopic hemostasis
7 days
Rate of rebleeding within 30 days of successful endoscopic hemostasis Except for cases of rebleeding within 7 days of successful endoscopic hemostasis)
Rate of rebleeding within 30 days of successful endoscopic hemostasis Except for cases of rebleeding within 7 days of successful endoscopic hemostasis)
30 days
Secondary Outcomes (8)
Check for haemostasis within 5 minutes from the moment of application of Nexpowder Analysis of patients with bleeding during the initial hemostasis experimental group
5 min
Perforation incidence
7 days
Death rate
7 days
Blood transfusion case rate
7 days
Number of Nexpowder applications (experimental group)
7 days
- +3 more secondary outcomes
Other Outcomes (1)
Abnormal response intestinal obstruction, including gas embolism during a 30-day follow-up period
30 days
Study Arms (2)
Conventional Treatment
ACTIVE COMPARATORConventional Treatment
Conventional Treatment + Nexpowder
EXPERIMENTALConventional Treatment + Nexpowder
Interventions
Hemostatic powder for endoscopy after colonoscopy polypectomy
Eligibility Criteria
You may qualify if:
- Adult volunteers aged 19 or older during screening
- A person who is scheduled to perform polypectomy for polyps with a diameter of 2 cm or more, such as Endoscopic Mucosal Resection (EMR) or Endoscopic Submucosal Dissection (ESD)
- If the researcher agrees to voluntarily participate in the clinical study and determines that the subject cannot voluntarily consent due to the elderly aged 80 or older or other emergency situations, a written consent of the subject's legal representative is required
You may not qualify if:
- Upper gastrointestinal bleeding
- If ulcerative bleeding is not caused by the procedure
- If you are suffering from a blood clotting disorder
- Aspirin and anticoagulant medications cannot be discontinued
- Pregnant or lactating
- Where colonoscopy is prohibited due to comorbid diseases, etc
- If the bleeding area cannot be identified or the bleeding area cannot be reached with an endoscope
- If you have participated in a relevant clinical trial that may affect the results of this study within the last one month
- Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose galactose malabsorption
- A person who is hypersensitive to food additive Blue No. 1 or has a history of allergies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Chungbuk National University Hospital
Cheongju-si, South Korea
Chungnam National University Hospital
Daejeon, South Korea
Chungnam National University Sejong Hospital
Sejong, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kibae Kim, Ph.D.
Chungbuk National University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2023
First Posted
June 1, 2023
Study Start
October 18, 2022
Primary Completion
December 1, 2023
Study Completion
December 29, 2023
Last Updated
February 23, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share