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OpenTrials
Completed

NCT Number: NCT05884931

Effectiveness and Safety of Nexpowder as an Endoscopic Hemostatic Treatment

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chungbuk National University Hospital, Cheongju-si, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nexpowder

Device

Hemostatic powder for endoscopy after colonoscopy polypectomy

Conventional treatment

Procedure

Standard hemostatic procedure

Primary outcomes

  1. Rate of rebleeding within 7 days of successful endoscopic hemostasis

    Time frame: 7 days

    Rate of rebleeding within 7 days of successful endoscopic hemostasis

  2. 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

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

Secondary outcomes

  1. 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

    Check for haemostasis within 5 minutes from the moment of application of Nexpowder Analysis of patients with bleeding during the initial hemostasis experimental group

  2. Perforation incidence

    Time frame: 7 days

    Perforation incidence

  3. Death rate

    Time frame: 7 days

    Death rate

  4. Blood transfusion case rate

    Time frame: 7 days

    Blood transfusion case rate

  5. Number of Nexpowder applications (experimental group)

    Time frame: 7 days

    Number of Nexpowder applications (experimental group)

  6. Number of usage of Nexpowder (experimental group)

    Time frame: 7 days

    Number of usage of Nexpowder (experimental group)

  7. Incidence of device malfunction (experimental group)

    Time frame: 7 days

    Incidence of device malfunction (experimental group)

  8. Rate of ease of use (experimental group)

    Time frame: 7 days

    Rate of ease of use (experimental group)

Other outcomes

  1. Abnormal response intestinal obstruction, including gas embolism during a 30-day follow-up period

    Time frame: 30 days

    Abnormal response intestinal obstruction, including gas embolism during a 30-day follow-up period

Sponsors and collaborators

Lead sponsor

Next Biomedical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 1, 2023
Registry last updated
Feb 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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