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NCT05913453 Clinical Trial

Technical Failure During Colorectal Endoscopic Full Thickness Resection (EFTR): The "Through Thick and Thin" Study

Colorectal Adenoma Clinical Trial

Official title:
Technical Failure During Colorectal Endoscopic Full Thickness Resection (EFTR): The "Through Thick and Thin" Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05913453
Other study ID # 2993
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 30, 2022
Est. completion date January 31, 2023

Study information
Verified date March 2023
Source Azienda Unità Sanitaria Locale della Romagna
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Among advanced resection techniques, endoscopic full thickness resection (EFTR) allows closure and full-thickness resection by the use of the non-exposed full thickness resection device (FTRD). The study is a retrospective analysis of technical failure occurring during colorectal full-thickness resection. Full thickness resection is a safe and effective procedure for "difficult" colorectal lesions. However, technical failure can occur and to date there is no evidence about type and clinical consequences in this setting.

Description:

The study is a multicentre retrospective study involving centres with experience in advanced colorectal resections. Each centre is invited to submit information about the Centre and to report alle the consecutive cases corresponding to technical failure.

Recruitment information / eligibility
Status Completed
Enrollment 77
Est. completion date January 31, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - Consecutive colorectal EFTR procedures with technical failure by using OVESCO Full Thickness Resection Device Exclusion Criteria: - EFTR performed by exposed techniques and/or devices different from FTRD - Patients not able to give informed consent for data collection

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy Ospedale Morgagni-Pierantoni Forlì Forlì-Cesena

Sponsors (1)
Lead Sponsor Collaborator
Azienda Unità Sanitaria Locale della Romagna

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Technical failure rate and classification 2014 - 2022
Secondary Conservative Management of technical failure Performance of rescue endoscopic resection 2014-2022
Secondary Clinical success (R0 resection) 2014-2022
Secondary Complication rate 2014-2022
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