Clinical trial NCT05884931: 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
Overall status: COMPLETED
Phase: NA
Conditions: GastroIntestinal Bleeding
Lead sponsor: Next Biomedical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-06-01
Enrollment: 66
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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of rebleeding within 7 days of successful endoscopic hemostasis
timeFrame: 7 days
measure: Rate of rebleeding within 30 days of successful endoscopic hemostasis Except for cases of rebleeding within 7 days of successful endoscopic hemostasis)
timeFrame: 30 days
Secondary outcomes:
measure: Check for haemostasis within 5 minutes from the moment of application of Nexpowder Analysis of patients with bleeding during the initial hemostasis experimental group
timeFrame: 5 min
measure: Perforation incidence
timeFrame: 7 days
measure: Death rate
timeFrame: 7 days
measure: Blood transfusion case rate
timeFrame: 7 days
measure: Number of Nexpowder applications (experimental group)
timeFrame: 7 days
measure: Number of usage of Nexpowder (experimental group)
timeFrame: 7 days
measure: Incidence of device malfunction (experimental group)
timeFrame: 7 days
measure: Rate of ease of use (experimental group)
timeFrame: 7 days
Other outcomes:
measure: Abnormal response intestinal obstruction, including gas embolism during a 30-day follow-up period
timeFrame: 30 days
Locations:
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Sejong
country: Korea, Republic of
facility: Chungnam National University Sejong Hospital
Study officials:
affiliation: Chungbuk National University Hospital
name: Kibae Kim, Ph.D.
role: STUDY_DIRECTOR
References: