Status:
UNKNOWN
Efficacy of PuraStat for the Prevention of Delayed Bleeding After Endoscopic Resection of Colorectal Lesions
Lead Sponsor:
Hospital Pedro Hispano
Conditions:
Bleeding After Resection of Colorectal Neoplastic Lesions
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 rec...
Detailed Description
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 mu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 28 2022
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT04516460
Start Date
July 28 2020
End Date
January 28 2022
Last Update
August 18 2020
Active Locations (1)
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1
Hospital Pedro Hispano
Matosinhos Municipality, Portugal