Last updated: February 20, 2024
Sponsor: Mathieu Pioche
Overall Status: Active - Recruiting
Phase
N/A
Condition
Hemorrhage
Treatment
Endoscopic submucosal dissection with Purastat
Clinical Study ID
NCT05031325
SFED 151
Ages 18-90 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients of both sexes aged 18 years or older
- Patient with a validated indication for colonoscopy for colorectal lesions
- Patients with a single colorectal lesion to be resected by ESD according to Europeanrecommendations.
- Patients with a colorectal neoplastic lesion (≥3 cm)
- Patients taking anticoagulants (acetylsalicylic acid >300 mg/day) or antiplateletagents (clopidogrel, prasugrel, ticagrelor, clopidogrel) and managed according toEuropean recommendations for ESD (including patients who may require heparinreplacement)
- Written consent signed after clear, fair, and understood information.
- Patients with social security coverage.
Exclusion
Exclusion Criteria:
- Patients who may have an allergic reaction to the substances of PuraStat®.
- Patients with severe fibrosis
- Patients with a history of familial colorectal polyposis (familial adenomatous, Lynchsyndrome, Peutz-Jeghers syndrome)
- Patients with a score ASA greater than or equal to 4 or 5
- Patients with a platelet count of 50,000/mm3
- Patients with acquired (non-medicated) or inherited bleeding disorders
- Patients who are being treated with acetylsalicylic acid but whose treatment isdiscontinued at the time of the procedure (therapeutic window)
- Patients with advanced cancer or inflammatory bowel disease, including ulcerativecolitis (with colonic involvement)
- Contraindication to general anesthesia
- Patients with a mental disorder, drug addiction, alcoholism, etc.
- Pregnant women or women wishing to become pregnant during the study
- Patients already participating or scheduled to participate in other clinical trials
- Lesion that has been previously resected by mucosectomy
- Patient with an initial metastatic lesion prior to colonoscopy.
- Patient unable to give personal consent
- Lack of signed informed consent
Study Design
Total Participants: 288
Treatment Group(s): 1
Primary Treatment: Endoscopic submucosal dissection with Purastat
Phase:
Study Start date:
February 28, 2022
Estimated Completion Date:
December 26, 2024
Connect with a study center
Hopital Edouard Herriot
Lyon,
FranceActive - Recruiting
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