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

NCT04516460 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2020-08-18

No results posted yet for this study

Summary

A Prospective Interventional Multicentric Study to Evaluate Effectiveness and Safety of PuraStat in the Management of delayed bleeding following Endoscopic Mucosal Resection (EMR) in the colon and rectum.

Conditions

  • Bleeding After Resection of Colorectal Neoplastic Lesions

Interventions

DEVICE

Interventional arm: endoscopic resection plus PuraStat®

Interventional arm: PuraStat® applied through a catheter delivery system via the endoscope is used to prevent bleeding after endoscopic resection of colorectal neoplastic lesions

Sponsors & Collaborators

  • Hospital Pedro Hispano

    lead OTHER

Principal Investigators

  • Masami Omae, MD · Karolinska Hospital

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-28
Primary Completion
2022-01-28
Completion
2022-01-28

Countries

  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04516460 on ClinicalTrials.gov