Clinical trial NCT04124588: Effectiveness of 'Nexpowder' for Hemostatic Treatments of Nonvariceal, Upper Gastrointestinal Bleeding
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nonvariceal Upper Gastrointestinal Bleeding
Lead sponsor: Next Biomedical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-10-11
Enrollment: 348
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: The rates of re-bleeding
timeFrame: 3 days
Secondary outcomes:
measure: Incidence of Treatment-Adverse Events & Long term Re-bleeding
timeFrame: 30 days (+5)
Other outcomes:
Locations:
city: Gyeonggi-do
country: Korea, Republic of
facility: Soon Chun Hyang University Bucheon Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon Gil Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
Study officials:
affiliation: NEXTBIOMEDICAL CO., LTD.
name: Eunhye Lee, Ph.D
role: STUDY_DIRECTOR
References: