Effectiveness and Safety of Nexpowder as an Endoscopic Hemostatic Treatment

GastroIntestinal Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05884931
• Other study ID #: Nexpowder_02
• Status: Completed
• Phase: N/A
• Start date: October 18, 2022
• Est. completion date: December 29, 2023

Study information

• Verified date: February 2024
• Source: Next Biomedical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 29, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• GastroIntestinal Bleeding
• Gastrointestinal Hemorrhage
• Hemorrhage

Intervention

Device:
• Nexpowder
Hemostatic powder for endoscopy after colonoscopy polypectomy

Procedure:
• Conventional Treatment
Standard hemostatic procedure

Locations

Country	Name	City	State
Korea, Republic of	Chungbuk National University Hospital	Cheongju-si
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Chungnam National University Sejong Hospital	Sejong

Sponsors (1)

Lead Sponsor	Collaborator
Next Biomedical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Rate of rebleeding within 7 days of successful endoscopic hemostasis	Rate of rebleeding within 7 days of successful endoscopic hemostasis	7 days
Primary	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	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
Secondary	Perforation incidence	Perforation incidence	7 days
Secondary	Death rate	Death rate	7 days
Secondary	Blood transfusion case rate	Blood transfusion case rate	7 days
Secondary	Number of Nexpowder applications (experimental group)	Number of Nexpowder applications (experimental group)	7 days
Secondary	Number of usage of Nexpowder (experimental group)	Number of usage of Nexpowder (experimental group)	7 days
Secondary	Incidence of device malfunction (experimental group)	Incidence of device malfunction (experimental group)	7 days
Secondary	Rate of ease of use (experimental group)	Rate of ease of use (experimental group)	7 days