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

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.

Study Overview

• Status: Completed
• Conditions: GastroIntestinal Bleeding
• Intervention / Treatment: Procedure: Conventional Treatment; Device: Nexpowder

Detailed Description

Total number of target subjects 66 Test group 33 / Control group: 33 If endoscopic polypectomy is performed on polyps of 2cm or more, the probability of bleeding as a complication is 6.5%. This clinical study is an observational study to confirm the safety and effectiveness of Nexpowder, an endoscopic hemostatic powder after colonoscopy polypectomy, and an exploratory evaluation of 60 patients is conducted.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kibae Kim; Phone Number: +82-32-454-4800; Email: next@nextbiomedical.co.kr

Study Locations

• Korea, Republic of
  • Cheongju-si, Korea, Republic of
    • Chungbuk National University Hospital
  • Daejeon, Korea, Republic of
    • Chungnam National University Hospital
  • Sejong, Korea, Republic of
    • Chungnam National University Sejong Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adult volunteers aged 19 or older during screening
2. 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)
3. 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

Exclusion Criteria:

1. Upper gastrointestinal bleeding
2. If ulcerative bleeding is not caused by the procedure
3. If you are suffering from a blood clotting disorder
4. Aspirin and anticoagulant medications cannot be discontinued
5. Pregnant or lactating
6. Where colonoscopy is prohibited due to comorbid diseases, etc
7. If the bleeding area cannot be identified or the bleeding area cannot be reached with an endoscope
8. If you have participated in a relevant clinical trial that may affect the results of this study within the last one month
9. Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose galactose malabsorption
10. A person who is hypersensitive to food additive Blue No. 1 or has a history of allergies
11. In the case where the researcher determines that it is inappropriate to participate in clinical trials due to other reasons other than the above selection exclusion criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional Treatment	Procedure: Conventional Treatment; Standard hemostatic procedure
Experimental: Conventional Treatment + Nexpowder	Device: Nexpowder; Hemostatic powder for endoscopy after colonoscopy polypectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Check for haemostasis within 5 minutes from the moment of application of Nexpowder Analysis of patients with bleeding during the initial hemostasis experimental group	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	Perforation incidence	7 days
Death rate	Death rate	7 days
Blood transfusion case rate	Blood transfusion case rate	7 days
Number of Nexpowder applications (experimental group)	Number of Nexpowder applications (experimental group)	7 days
Number of usage of Nexpowder (experimental group)	Number of usage of Nexpowder (experimental group)	7 days
Incidence of device malfunction (experimental group)	Incidence of device malfunction (experimental group)	7 days
Rate of ease of use (experimental group)	Rate of ease of use (experimental group)	7 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abnormal response intestinal obstruction, including gas embolism during a 30-day follow-up period	Abnormal response intestinal obstruction, including gas embolism during a 30-day follow-up period	30 days

Collaborators and Investigators

• Sponsor: Next Biomedical Co., Ltd.
• Investigators: Study Director: Kibae Kim, Ph.D., Chungbuk National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2022
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): December 29, 2023

Study Registration Dates

• First Submitted: May 8, 2023
• First Submitted That Met QC Criteria: May 23, 2023
• First Posted (Actual): June 1, 2023

Study Record Updates

• Last Update Posted (Estimated): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Hemorrhage; Gastrointestinal Hemorrhage
• Other Study ID Numbers: Nexpowder_02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No