Additive Hemostatic Efficacy of EndoClot After EMR or ESD in the Gastrointestinal Tract
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|ClinicalTrials.gov Identifier: NCT02688699|
Recruitment Status : Not yet recruiting
First Posted : February 23, 2016
Last Update Posted : April 28, 2021
|Condition or disease||Intervention/treatment||Phase|
|Colonic Polyp Colonic Neoplasms Colonic Dysplasia||Procedure: EndoClot||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||288 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Italian Multicenter Prospective Randomized Trial to Compare Additive Hemostatic Efficacy of EndoClot System to Prevent Bleeding After Endoscopic Mucosal Resection or Endoscopic Submucosal Dissection of Lesions in the Gastrointestinal Tract|
|Estimated Study Start Date :||September 2021|
|Estimated Primary Completion Date :||February 2022|
|Estimated Study Completion Date :||March 2022|
spraying of Endoclot powder after EMR or ESD
All patients enrolled and submitted to EMR or ESD in several units of Italian endoscopy will be divided into two different groups: in a first group will be included patients at the endoscopic end of which will be applied EndoClotTM based on the lesion removed in addition to the treatment Standard (drug injection, electrocoagulation, metal clips). The second group, on the other hand, includes patients in whom EndoClotTM will not be used.
Before the end of the procedure neither the endoscopist nor the patient will know the group because the group to which the patient is assigned will be written in a sealed envelope that will be opened only at the end of the procedure before the endoscope extraction: The use of EndoClotTM will depend on the group to which the patient belongs.
|No Intervention: control|
- effectiveness of EndoClotTM in preventing post-procedural bleeding [ Time Frame: 14 days ]The investigators want to verify in a randomised trial, the effectiveness of EndoClotTM in preventing post-procedural bleeding after EMR (Endoscopic Mucosal Resection) or ESD (Endoscopic Submucosal Dissection) for sessile lesions >20 mm in the right colon
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02688699
|Contact: Alberto Arezzo, MDfirstname.lastname@example.org|