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Effectiveness of 'Nexpowder' for Hemostatic Treatments of Nonvariceal, Upper Gastrointestinal Bleeding

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ClinicalTrials.gov Identifier: NCT04124588
Recruitment Status : Recruiting
First Posted : October 11, 2019
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
Next Biomedical Co., Ltd.

Brief Summary:

A prospective, multi-center, multi-national, randomized controlled trial to evaluate safety and effectiveness of endoscopic hemostatic powder, 'Nexpowder' for hemostatic treatments of nonvariceal upper gastrointestinal bleeding.

This study is a prospective, multi-national, multi-center, single blind (for patients), controlled investigation planned to evaluate safety and effectiveness of Nexpowder with 352 subject patients.


Condition or disease Intervention/treatment Phase
Nonvariceal Upper Gastrointestinal Bleeding Device: Nexpowder (Hemostatic powder) Device: Conventional Technique Not Applicable

Detailed Description:

This investigational study is designed to compare effectiveness of using the standard-of-care hemostatic therapy only, versus the standard-of-care hemostatic therapy plus an additional hemostatic treatment using Nexpower for patients with nonvariceal, upper gastrointestinal bleeding from ulcers with high-risk stigmata (Forrest classification Ia, Ib, or IIa).

The primary end-points will be evaluated by assessing the rates of re-bleeding, which occur over three (3) days following initial hemostasis achieved with the standard-of-care hemostatic therapy.

Secondary end-points consist of evaluating three items: 1) Ease of use of Nexpowder applied for the test group after reaching initial hemostasis, 2) Nexpowder device malfunction and 3) safety follow-up to check occurrence of adverse event(s)/re-bleeding at 30-day (+5) time point.

Only the subjects whose initial hemostasis has been achieved will be registered for this investigation but those who initial hemostasis has failed to be reached with the standard-of-care therapie(s) shall not be registered for this investigation.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 356 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-national, Multicenter, Randomized Controlled Trial to Evaluate Safety and Effectiveness of Endoscopic Hemostactic Powder, 'Nexpowder' for Hemostatic Treatments of Nonvariceal, Upper Gastrointestinal Bleeding
Actual Study Start Date : March 29, 2019
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Test group
"After" achieving initial hemostasis only with the standard-of-care, endoscopic hemostatic therapie(s)
Device: Nexpowder (Hemostatic powder)
Nexpowder generates gelation-effects when the powder comes into contact with water, forms a physical barrier to control hemorrhage, preserve ulcer sites and thereby demonstrates its effective hemostatic performance. Hydrogels, which turned into gel-formation through water contacts in the gastrointestinal tract protect the wound sites for over 24 hours, are subsequently detached from the lesion, and completely excreted from the patient body system within 3 days.

Device: Conventional Technique
Argon Plasma Coagulation, Coagulation including Forcep, Hemoclipping, Band Ligation, Epinephrine or Absolute Alcohol Injecction can be used as standard-of-care hemostatic treatment(s).

Active Comparator: Control gruop
"After" achieving initial hemostasis only with the standard-of-care, Wrap up the first endoscopy without adding an additional procedure.
Device: Conventional Technique
Argon Plasma Coagulation, Coagulation including Forcep, Hemoclipping, Band Ligation, Epinephrine or Absolute Alcohol Injecction can be used as standard-of-care hemostatic treatment(s).




Primary Outcome Measures :
  1. The rates of re-bleeding [ Time Frame: 3 days ]
    Assessing the rates of re-bleeding, which occur over three (3) days following initial hemostasis achieved with the standard-of-care hemostatic therapy.


Secondary Outcome Measures :
  1. Incidence of Treatment-Adverse Events & Long term Re-bleeding [ Time Frame: 30 days (+5) ]
    Safety follow-up to check occurrence of adverse event(s)/re-bleeding.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult male or female with age of older than 19 years.
  • Patients showing non-variceal upper GI bleeding symptoms
  • An endoscopic examination indicates that the patients's ulcer is categorized Class Ia, Ib, or IIa according to the Forrest Classifications.

Exclusion Criteria:

  • Pregnant or breast-feeding patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04124588


Contacts
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Contact: Eunhye Lee, Ph.D 82-32-858-9404 eunhye.lee@unidds.com
Contact: Jin Hee maeng, MS 82-32-858-9404 jinhee.maeng@unidds.com

Locations
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Korea, Republic of
Soon Chun Hyang University Bucheon Hospital Recruiting
Gyeonggi-do, Korea, Republic of, 14584
Contact: Su-Jin hong, MD Ph.D         
Gachon Gil Hospital Recruiting
Incheon, Korea, Republic of, 21565
Contact: Kyung-Oh Kim, MD, Ph.D         
Principal Investigator: Kyung-Oh Kim, MD, Ph.D         
Inha University Hospital Recruiting
Incheon, Korea, Republic of, 22332
Contact: Hyung-Gil Kim, MD Ph.D         
Sponsors and Collaborators
Next Biomedical Co., Ltd.

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Responsible Party: Next Biomedical Co., Ltd.
ClinicalTrials.gov Identifier: NCT04124588     History of Changes
Other Study ID Numbers: NEXTBIO-632-EWD3
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastrointestinal Hemorrhage
Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Hemostatics
Coagulants