NCT05913453

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
Last Updated

June 22, 2023

Status Verified

March 1, 2023

Enrollment Period

1 month

First QC Date

March 24, 2023

Last Update Submit

June 12, 2023

Conditions

Endoscopic Full Thickness Resection (EFTR)Residual /Recurrent Colorectal LesionFull-thickness Resection Device (FTRD)Colorectal AdenomaNon-lifting Colorectal LesionsIntraprocedural Complication

Outcome Measures

Primary Outcomes (1)

  • Technical failure rate and classification

    2014 - 2022

Secondary Outcomes (3)

  • Conservative Management of technical failure

    2014-2022

  • Clinical success (R0 resection)

    2014-2022

  • Complication rate

    2014-2022

Study Arms (1)

Procedures corresponding to technical failure

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing colorectal EFTR with occurrence of technical failure.

You may qualify if:

  • Consecutive colorectal EFTR procedures with technical failure by using OVESCO Full Thickness Resection Device

You may not qualify if:

  • EFTR performed by exposed techniques and/or devices different from FTRD
  • Patients not able to give informed consent for data collection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale Morgagni-Pierantoni

Forlì, Forlì-Cesena, Italy

Location

Related Publications (1)

  • Gibiino G, Binda C, Papparella LG, Spada C, Andrisani G, Di Matteo FM, Gagliardi M, Maurano A, Sferrazza S, Azzolini F, Grande G, de Nucci G, Cesaro P, Aragona G, Cennamo V, Fusaroli P, Staiano T, Soriani P, Campanale M, Di Mitri R, Pugliese F, Anderloni A, Cucchetti A, Repici A, Fabbri C; "through thick and thin" study group. Technical failure during colorectal endoscopic full-thickness resection: the "through thick and thin" study. Endoscopy. 2024 Nov;56(11):831-839. doi: 10.1055/a-2328-4753. Epub 2024 May 16.

    PMID: 38754466DERIVED

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

March 24, 2023

First Posted

June 22, 2023

Study Start

November 30, 2022

Primary Completion

December 31, 2022

Study Completion

January 31, 2023

Last Updated

June 22, 2023

Record last verified: 2023-03

Locations

IT(1)