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Search / Trial NCT04516460

Efficacy of PuraStat for the Prevention of Delayed Bleeding After Endoscopic Resection of Colorectal Lesions

Launched by HOSPITAL PEDRO HISPANO · Aug 15, 2020

Trial Information

Current as of July 21, 2025

Unknown status

Keywords

ClinConnect Summary

1. BACKGROUND \& RATIONALE

Endoscopic resection is used frequently for the management of benign and early neoplastic gastrointestinal (GI) lesions. Bleeding can occur during or after endoscopic mucosal resection and may impact patient's morbidity and mortality. Following colorectal endoscopic mucosal resection (EMR), the delayed bleeding rate may range between 5 and 9% \[1, 2\]. Several endoscopic hemostatic therapies based on coagulation, clipping or adrenaline may be used to prevent or treat post-polypectomy bleeding.

Adrenaline has a temporary effect, is associated with reduction...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • All of the following:
  • Presence of 1 lesion \>2cm in the colon or rectum
  • Patients able to give informed consent.
  • Patients over 18 years of age.
  • Exclusion Criteria:
  • ANY of the following:
  • resection of more than one large (≥20mm) polyp
  • ulcerated lesion (Paris III morphology)
  • lesions with invasive component
  • inflammatory bowel disease
  • poor health condition (American Society of Anesthesiologists class IV) resection by -endoscopic submucosal dissection
  • incomplete EMR
  • use of clips in the mucosal defect
  • previous attempts of endoscopic resection of the same lesion suspected deep damage in the muscularis propria
  • coagulation disorder (international normalized ratio \>1.5, platelets \<50) pregnancy

About Hospital Pedro Hispano

Hospital Pedro Hispano is a leading healthcare institution dedicated to advancing medical research and patient care through innovative clinical trials. Located in Portugal, the hospital is renowned for its commitment to excellence in clinical practice and research, providing comprehensive services across various medical specialties. With a multidisciplinary team of experienced professionals, Hospital Pedro Hispano aims to enhance treatment options and improve health outcomes by actively participating in cutting-edge clinical studies. The institution fosters collaboration among researchers, healthcare providers, and patients, ensuring the highest ethical standards and scientific rigor in all its clinical trial endeavors.

Locations

Matosinhos, , Portugal

Patients applied

0 patients applied

Trial Officials

Masami Omae, MD

Study Chair

Karolinska Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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