Purastat Study in Colonic Diverticular Bleeding

JRCT ID: jRCTs072240074

Registered date:28/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Colonic Diverticular Bleeding
• Date of first enrollment: 28/10/2024
• Target sample size: 60
• Study type: Interventional
• Intervention(s): For patients who require emergency endoscopic hemostasis, we will perform hemostasis using Purestat (combined with EBL or Clipping)

Outcome(s)

• Primary Outcome: Rebleeding rate within 30 days after emergency colonoscopic hemostasis

Secondary Outcome

Adverse events of emergency colonoscopic hemostasis
Hemostatic method:combined with EBL or Clipping
Success rate of hemostasis immediately after surgery
Treatmentrelated factors :experience years of surgeon and procedure time

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients who have given written consent of their own free will
2) Those who are 18 years of age or older at the time of obtaining consent, regardless of gender
3) Patients scheduled to undergo emergency colonoscopy for colonic diverticular bleeding with SRH

Exclude criteria

1) Patients with unstable vitals (systolic blood pressure less than 80 mm/Hg or pulse less than 50 bpm or SpO2 less than 90% even on oxygen) at the time of emergency colonoscopy
2) Patients with low GCS (E3V4M5 or less) with a low level of consciousness
3) Patients with ASA-PS of III/IV (with severe systemic diseases)
4) Patients with severe liver or kidney damage.
5) Patients who are in pregnancy or suspected of being pregnant, and who are under breast feeding or wishing to become pregnant during the study.
6) Patients deemed inappropriate for inclusion by the principal investigator or a sub-investigator in the study.
7) Patients with a history of hypersensitivity to peptide or protein preparations.

Related Information

• Primary Sponsor: Daisuke Yamaguchi
• Source(s) of Monetary Support: 3-D Matrix Medical Technology,3-D Matrix Medical Technology