CompletedNot Applicable

Effectiveness and Safety of Nexpowder as an Endoscopic Hemostatic Treatment

South Korea66 participantsStarted 2022-10-18

Plain-language 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.

Who can participate

Age range19 Years

SexALL

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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

What they're measuring

Rate of rebleeding within 7 days of successful endoscopic hemostasis

Timeframe: 7 days

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

Trial details

NCT IDNCT05884931

SponsorNext Biomedical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12-01

View on ClinicalTrials.gov More GastroIntestinal Bleeding trials