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Effectiveness and Safety of Nexpowder as an Endoscopic Hemostatic Treatment

Primary Purpose

GastroIntestinal Bleeding

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Nexpowder
Conventional Treatment
Sponsored by
Next Biomedical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for GastroIntestinal Bleeding

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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 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

Sites / Locations

  • Chungbuk National University HospitalRecruiting
  • Chungnam National University HospitalRecruiting
  • Chungnam National University Sejong HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional Treatment

Conventional Treatment + Nexpowder

Arm Description

Conventional Treatment

Conventional Treatment + Nexpowder

Outcomes

Primary Outcome Measures

Rate of rebleeding within 7 days of successful endoscopic hemostasis
Rate 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)
Rate of rebleeding within 30 days of successful endoscopic hemostasis Except for cases of rebleeding within 7 days of successful endoscopic hemostasis)

Secondary Outcome Measures

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
Perforation incidence
Perforation incidence
Death rate
Death rate
Blood transfusion case rate
Blood transfusion case rate
Number of Nexpowder applications (experimental group)
Number of Nexpowder applications (experimental group)
Number of usage of Nexpowder (experimental group)
Number of usage of Nexpowder (experimental group)
Incidence of device malfunction (experimental group)
Incidence of device malfunction (experimental group)
Rate of ease of use (experimental group)
Rate of ease of use (experimental group)

Full Information

First Posted
May 8, 2023
Last Updated
May 23, 2023
Sponsor
Next Biomedical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05884931
Brief Title
Effectiveness and Safety of Nexpowder as an Endoscopic Hemostatic Treatment
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2022 (Actual)
Primary Completion Date
August 12, 2023 (Anticipated)
Study Completion Date
October 18, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Next Biomedical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
GastroIntestinal Bleeding

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional Treatment
Arm Type
Active Comparator
Arm Description
Conventional Treatment
Arm Title
Conventional Treatment + Nexpowder
Arm Type
Experimental
Arm Description
Conventional Treatment + Nexpowder
Intervention Type
Device
Intervention Name(s)
Nexpowder
Intervention Description
Hemostatic powder for endoscopy after colonoscopy polypectomy
Intervention Type
Procedure
Intervention Name(s)
Conventional Treatment
Intervention Description
Standard hemostatic procedure
Primary Outcome Measure Information:
Title
Rate of rebleeding within 7 days of successful endoscopic hemostasis
Description
Rate of rebleeding within 7 days of successful endoscopic hemostasis
Time Frame
7 days
Title
Rate of rebleeding within 30 days of successful endoscopic hemostasis Except for cases of rebleeding within 7 days of successful endoscopic hemostasis)
Description
Rate of rebleeding within 30 days of successful endoscopic hemostasis Except for cases of rebleeding within 7 days of successful endoscopic hemostasis)
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Check for haemostasis within 5 minutes from the moment of application of Nexpowder Analysis of patients with bleeding during the initial hemostasis experimental group
Description
Check for haemostasis within 5 minutes from the moment of application of Nexpowder Analysis of patients with bleeding during the initial hemostasis experimental group
Time Frame
5 min
Title
Perforation incidence
Description
Perforation incidence
Time Frame
7 days
Title
Death rate
Description
Death rate
Time Frame
7 days
Title
Blood transfusion case rate
Description
Blood transfusion case rate
Time Frame
7 days
Title
Number of Nexpowder applications (experimental group)
Description
Number of Nexpowder applications (experimental group)
Time Frame
7 days
Title
Number of usage of Nexpowder (experimental group)
Description
Number of usage of Nexpowder (experimental group)
Time Frame
7 days
Title
Incidence of device malfunction (experimental group)
Description
Incidence of device malfunction (experimental group)
Time Frame
7 days
Title
Rate of ease of use (experimental group)
Description
Rate of ease of use (experimental group)
Time Frame
7 days
Other Pre-specified Outcome Measures:
Title
Abnormal response intestinal obstruction, including gas embolism during a 30-day follow-up period
Description
Abnormal response intestinal obstruction, including gas embolism during a 30-day follow-up period
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kibae Kim
Phone
+82-32-454-4800
Email
next@nextbiomedical.co.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kibae Kim, Ph.D.
Organizational Affiliation
Chungbuk National University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Chungbuk National University Hospital
City
Cheongju-si
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kibae Kim
Phone
+82-32-454-4800
Email
next@nextbiomedical.co.kr
Facility Name
Chungnam National University Hospital
City
Daejeon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heeseok Moon
Phone
+82-32-454-4800
Email
next@nextbiomedical.co.kr
Facility Name
Chungnam National University Sejong Hospital
City
Sejong
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juseok Kim
Phone
+82-32-454-4800
Email
next@nextbiomedical.co.kr

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectiveness and Safety of Nexpowder as an Endoscopic Hemostatic Treatment

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