Endoscopic Full Thickness Resection (EFTR)NCT05913453
Technical Failure During Colorectal Endoscopic Full Thickness Resection (EFTR): The "Through Thick and Thin" Study
An observational study of Endoscopic Full Thickness Resection (EFTR) and Residual /Recurrent Colorectal Lesion, run by Azienda Unità Sanitaria Locale della Romagna at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Endoscopic Full Thickness Resection (EFTR), Residual /Recurrent Colorectal Lesion, Full-thickness Resection Device (FTRD)
- How many people
- 77 participants
- Where
- 1 siteItaly
- Study dates
- 30 Nov 2022to 31 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing colorectal EFTR with occurrence of technical failure.
Who may be able to join
- Consecutive colorectal EFTR procedures with technical failure by using OVESCO Full Thickness Resection Device
Who cannot join
- EFTR performed by exposed techniques and/or devices different from FTRD
- Patients not able to give informed consent for data collection
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the detailed 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Procedures corresponding to technical failure | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical failure rate and classification
Measured: 2014 - 2022
Secondary outcomes (3)
Conservative Management of technical failure
Performance of rescue endoscopic resection
Measured: 2014-2022
Clinical success (R0 resection)
Measured: 2014-2022
Complication rate
Measured: 2014-2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start30 Nov 2022
- Primary completion31 Dec 2022
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endoscopic Full Thickness Resection (EFTR)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Unità Sanitaria Locale della Romagna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlo Fabbri, Azienda Unità Sanitaria Locale della Romagna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05913453
- Sponsor's protocol ID
- 2993
- Status last verified
- Mar 2023
- First submitted
- 24 Mar 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual Participant Data require data about experience in colorectal resections and EFTR; each centre will provide details for each technical failure including demographics, lesions characteristics, intraprocedural details and post-procedure outcomes.
Publications
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.
PubMed 38754466
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technical Failure During Colorectal Endoscopic Full Thickness Resection (EFTR): The "Through Thick and Thin" Study
- ClinicalTrials.gov ID
- NCT05913453
- Acronym / sponsor ID
- 2993
- Conditions
- Endoscopic Full Thickness Resection (EFTR), Residual /Recurrent Colorectal Lesion, Full-thickness Resection Device (FTRD), Colorectal Adenoma, Non-lifting Colorectal Lesions, Intraprocedural Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Azienda Unità Sanitaria Locale della RomagnaUniversity, hospital or other
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Procedures corresponding to technical failure | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing colorectal EFTR with occurrence of technical failure.
Key inclusion criteria (1 listed)
- Consecutive colorectal EFTR procedures with technical failure by using OVESCO Full Thickness Resection Device
Key exclusion criteria (2 listed)
- EFTR performed by exposed techniques and/or devices different from FTRD
- Patients not able to give informed consent for data collection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Technical failure rate and classification
Time frame: 2014 - 2022
3 secondary outcomes
Conservative Management of technical failure
Time frame: 2014-2022
Clinical success (R0 resection)
Time frame: 2014-2022
Complication rate
Time frame: 2014-2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Derived from this study: PubMed 38754466Gibiino 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.
- Individual participant dataSharing planned: Undecided. Individual Participant Data require data about experience in colorectal resections and EFTR; each centre will provide details for each technical failure including demographics, lesions characteristics, intraprocedural details and post-procedure outcomes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endoscopic Full Thickness Resection (EFTR) and Residual /Recurrent Colorectal Lesion, run by Azienda Unità Sanitaria Locale della Romagna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical failure rate and classification (time frame: 2014 - 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05913453, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.