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Purastat Study in Colonic Diverticular Bleeding

Efficacy and Safety of Endoscopic Hemostasis with PuraStat in Colonic Diverticular Bleeding : A Multicenter Prospective Study - PURA-CDB study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs072240074
Enrollment
60
Registered
2024-10-28
Start date
2024-11-06
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonic Diverticular Bleeding Colonic diverticulum bleeding,Colonoscopy, Emergency endoscopic hemostasis

Interventions

For patients who require emergency endoscopic hemostasis, we will perform hemostasis using Purestat (combined with EBL or Clipping)

Sponsors

Daisuke Yamaguchi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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) Patient with low consciousness level (GCS specifically E3V4M5 or less) during emergency endoscopic hemostasis for colorectal bleeding 3) Patients with ASA-PS Class IV or V (with severe systemic disease) 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.

Design outcomes

Primary

MeasureTime frame
Rebleeding rate within 30 days after emergency colonoscopic hemostasis

Secondary

MeasureTime frame
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

Contacts

Public ContactYamaguchi Daisuke

Saga University Hospital

daisukehawks@gmail.com+81-952316511

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026