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EndoscoPic Submucosal dIssection Using geL Versus glycerOl for Submucosal iNjection

NCT04977401 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2023-10-23

No results posted yet for this study

Summary

The EPSILON study aims to comparatively evaluate the submucosal injection using ORISETM gel and glycerol during an ESD procedure in a specific population with superficial gastric and rectal (pre)neoplastic lesions.

Conditions

  • Early Gastric Cancer
  • Rectal Polyp

Interventions

PROCEDURE

Endoscopic submucosal dissection

Dissecting superficial gastric or rectal lesion/polyp after injection of the submucosa for lifting, using a electrosurgical knife through the endoscope

DEVICE

use of Orise Gel as lifting agent for endoscopic submucosal dissection

Injection of some colloidal solution (ORISE gel) in the submucosal layer in order to obtain long lifting effect and thus allowing the endoscopist to dissect under the lesion.

DEVICE

use of glycerol as lifting agent for endoscopic submucosal dissection

Injection of some colloidal solution (glycerol) in the submucosal layer in order to obtain long lifting effect and thus allowing the endoscopist to dissect under the lesion.

Sponsors & Collaborators

  • Erasme University Hospital

    lead OTHER

Principal Investigators

  • Arnaud Lemmers, MD,PhD · Erasme Hospital, Université Libre de Bruxelles. (ULB), Brussels, Belgium

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-21
Primary Completion
2022-12-15
Completion
2023-01-05

Countries

  • Belgium
  • Germany
  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04977401 on ClinicalTrials.gov