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

• Sponsor: Next Biomedical Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04124588
• Collaborator: (none)
• Enrollment: 349
• Locations: 3
• Arms: 2
• Actual Duration (Months): 32.2
• Patients Per Site: 116.3
• Patients Per Site Per Month: 3.6

Study Details

Study Description

Brief Summary

A prospective, multi-center, 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-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	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 349 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Prospective, 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: Mar 29, 2019
• Actual Primary Completion Date: Nov 30, 2021
• Actual Study Completion Date: Dec 3, 2021

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

1. The rates of re-bleeding [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 [30 days (+5)]

   Safety follow-up to check occurrence of adverse event(s)/re-bleeding.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Soon Chun Hyang University Bucheon Hospital	Gyeonggi-do		Korea, Republic of	14584
2	Gachon Gil Hospital	Incheon		Korea, Republic of	21565
3	Inha University Hospital	Incheon		Korea, Republic of	22332

Sponsors and Collaborators

• Next Biomedical Co., Ltd.

Investigators

• Study Director: Eunhye Lee, Ph.D, NEXTBIOMEDICAL CO., LTD.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Next Biomedical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04124588
• Other Study ID Numbers: NEXTBIO-632-EWD3
• First Posted: Oct 11, 2019
• Last Update Posted: Dec 7, 2021
• Last Verified: Dec 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Gastrointestinal Hemorrhage; Hemorrhage; Hemostatics

Study Results

No Results Posted as of Dec 7, 2021