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OpenTrials
Completed

NCT Number: NCT05913453

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

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.

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Key information

Conditions

Endoscopic Full Thickness Resection (EFTR) Colorectal Adenoma Full-thickness Resection Device (FTRD) Intraprocedural Complication Non-lifting Colorectal Lesions Residual /Recurrent Colorectal Lesion

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale Morgagni-Pierantoni

Forlì, Forlì-Cesena, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Technical failure rate and classification

    Time frame: 2014 - 2022

Secondary outcomes

  1. Conservative Management of technical failure

    Time frame: 2014-2022

    Performance of rescue endoscopic resection

  2. Clinical success (R0 resection)

    Time frame: 2014-2022

  3. Complication rate

    Time frame: 2014-2022

Sponsors and collaborators

Lead sponsor

Azienda Unità Sanitaria Locale della Romagna

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jun 22, 2023
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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