Additive Hemostatic Efficacy of EndoClot After EMR or ESD in the Gastrointestinal Tract
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
1 other identifier
interventional
288
0 countries
N/A
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2023
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2016
CompletedFirst Posted
Study publicly available on registry
February 23, 2016
CompletedStudy Start
First participant enrolled
September 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2024
CompletedMay 16, 2023
May 1, 2023
5 months
February 17, 2016
May 13, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
effectiveness of EndoClotTM in preventing post-procedural bleeding
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
14 days
Study Arms (2)
EndoClot
EXPERIMENTALspraying of Endoclot powder after EMR or ESD
control
NO INTERVENTIONInterventions
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.
Eligibility Criteria
You may qualify if:
- \>18 years old
- lesions suitable for EMR or ESD
- \> 20 mm
- site in the right colon
You may not qualify if:
- Severe cardiovascular pathologies
- Liver and Urinary dysfunctions
- Hematologic diseases
- Pregnancy and breast feeding
- impossible follow-up
- platelet and coagulation disorders (PLT \< 50 x 109/L, INR \> 2)
- Sensitivity or allergy to the drug
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Surgery, MD
Study Record Dates
First Submitted
February 17, 2016
First Posted
February 23, 2016
Study Start
September 1, 2023
Primary Completion
February 1, 2024
Study Completion
March 1, 2024
Last Updated
May 16, 2023
Record last verified: 2023-05