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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02688699

Enrollment

288

Registered

2016-02-23

Start date

2023-09-30

Completion date

2024-03-31

Last updated

2023-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonic Dysplasia, Colonic Neoplasms, Colonic Polyp

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

Interventions

PROCEDUREEndoClot

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* \>18 years old * lesions suitable for EMR or ESD * \> 20 mm * site in the right colon

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
effectiveness of EndoClotTM in preventing post-procedural bleeding	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

Contacts

Primary ContactAlberto Arezzo, MD

alberto.arezzo@unito.it+393358378243

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026