MedTrace Logo

Full Thickness Resection or Endoscopic Submucosal Dissection for Difficult Colorectal Lesions.

NCT05502276 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2022-11-03

No results posted yet for this study

Summary

Compare the efficacy and safety of endoscopic resection a full thickness (EFTR) with Full Thickness Resection Device (FTRD) System versus endoscopic submucosal dissection (ESD) in the treatment of Laterally Spreading Tumor Non Granular Type (LST-NG), "no lift" lesions colon and residual / relapse on scars from previous resections endoscopic colon. The dimensional cut off of these lesions is ≤30mm

Conditions

  • Colorectal Neoplasms

Interventions

PROCEDURE

Endoscopic Full-Thickness Resection (EFTR)

Full Thickness Endoscopic Resection using the FTRD Ovesco Device

PROCEDURE

Endoscopic Submucosal Dissection (ESD)

Standard Endoscopic Submucosal Dissection using standard procedure described in international guidelines.

Sponsors & Collaborators

  • University of Roma La Sapienza

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2022-02-28
Completion
2022-09-30

Countries

  • Italy

Study Locations

More Related Trials

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 NCT05502276 on ClinicalTrials.gov