NCT05502276

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

Endoscopic Full Thickness Resection (EFTR) Versus Endoscopic Submucosal Dissection (ESD) in the Treatment of Difficult Colorectal Lesions With Dimensional Cut-off ≤ 30mm: Laterally Spreading Tumor Non Granular Type (LST-NG), "no Lift" Lesions and Residual / Relapses of Previous Resections. Endoscopic.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: University of Roma La Sapienza · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2019-01-01
• Primary completion: 2022-02-28
• Completion: 2022-09-30
• First posted: 2022-08-16
• Last updated: 2022-11-03

Locations

1 site across 1 country: Italy