AdenomaFiRENCT02353533
Endoscopic Full-thickness REsection of Residual Colorectal Lesions - The FiRE Study
A study testing over- the- scope full- thickness resection device (FTRD) and EMR in people with Adenoma, run by Technical University of Munich at 1 site in Germany.
Trial summary
Adenomatous lesions of the colon are premalignant lesions which have the potential to develop cancer. Therefore adenomas should be resected endoscopically (endo- mucosa resection, EMR). EMR is conducted after submucosal injection of saline which allows to lift the desired lesion prior to resection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenoma
- What is being tested?
- over- the- scope full- thickness resection device (FTRD) and EMR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2015to Dec 2017
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients ≥ 18 years
- adenomatous lesion 10-20 mm in size with expected difficulties regarding EMR (e.g. "non- lifting sign")
Who cannot join
- patients < 18 years
- lesions > 20 mm in size
- high risk carcinomas ("deep submucosal carcinoma")
- American Society of Anesthesiologists (ASA) class IV and higher
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München
Munich, 81675
Peter Klare, MD, +49 89 4140 2251, peter.klare@lrz.tum.de
Stefan von Delius, MD, +49 89 4140 5973, stefan_ruckert@yahoo.de
About this study
Adenomatous lesions of the colon are premalignant lesions which have the potential to develop cancer. Therefore adenomas should be resected endoscopically (endo- mucosa resection, EMR). EMR is conducted after submucosal injection of saline which allows to lift the desired lesion prior to resection. In some cases EMR is complicated due to incomplete or failed lifting after the injection of saline. This so- called "non- lifting" sign is a predictor for malignancy of the lesion. Difficult- to- lift polyps are also difficult- to- resect. A higher proportion of these lesions fail to be resected completely using the EMR technique.
Alternatively, an over- the- scope full- thickness resection device (FTRD) can be used in order to resect colonic lesions. The FTRD technique has been described elsewhere (Schmidt et al. Gastroenterology 2014; 147: 740-742.e2). No comparative data exists until now on the performance of FTRD resection compared to standard EMR resection of difficult- to- resect colon adenomas.
In this study the investigators aim to compare the success of FTRD versus EMR of difficult- to- resect adenomatous lesions (≤ 20 mm).
- Conditions
- Adenoma
- Being tested
- over- the- scope full- thickness resection device (FTRD), EMR
- Keywords
- adenoma, EMR, FTRD, non- lifting, colon
- Medical subject headings
- Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
over- the- scope full- thickness resection device (FTRD)Device
Endoscopic resection of adenomatous lesions of the colon using the over- the- scope full- thickness resection device
EMRDevice
Standard endoscopic mucosal resection using a resection snare
| Study group | Role | What they receive |
|---|---|---|
| EMR | Other | Standard EMR technique Receives: Device: EMR |
| FTRD | Experimental | Not described Receives: Device: over- the- scope full- thickness resection device (FTRD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of resection
Success of resection: Complete resection (R0) according to clinical and/or histopathological assessment
Measured: 3 month
Secondary outcomes (1)
Duration of procedure
Measured: up to 1 day (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionOct 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenomaStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Peter Klare, Technical University of Munich
- Investigators
- Stefan von Delius, MD, Study director, II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02353533
- Sponsor's protocol ID
- FiRE
- Acronym
- FiRE
- Status last verified
- Nov 2016
- First submitted
- 23 Jan 2015
- Last updated
- 21 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Full-thickness REsection of Residual Colorectal Lesions - The FiRE Study
- ClinicalTrials.gov ID
- NCT02353533
- Acronym / sponsor ID
- FiRE / FiRE
- Conditions
- Adenoma
- Keywords
- adenoma, EMR, FTRD, non- lifting, colon
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 2 Feb 2015 (estimated)
- 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.
Adenomatous lesions of the colon are premalignant lesions which have the potential to develop cancer. Therefore adenomas should be resected endoscopically (endo- mucosa resection, EMR). EMR is conducted after submucosal injection of saline which allows to lift the desired lesion prior to resection. In some cases EMR is complicated due to incomplete or failed lifting after the injection of saline. This so- called "non- lifting" sign is a predictor for malignancy of the lesion. Difficult- to- lift polyps are also difficult- to- resect. A higher proportion of these lesions fail to be resected completely using the EMR technique.
Alternatively, an over- the- scope full- thickness resection device (FTRD) can be used in order to resect colonic lesions. The FTRD technique has been described elsewhere (Schmidt et al. Gastroenterology 2014; 147: 740-742.e2). No comparative data exists until now on the performance of FTRD resection compared to standard EMR resection of difficult- to- resect colon adenomas.
In this study the investigators aim to compare the success of FTRD versus EMR of difficult- to- resect adenomatous lesions (≤ 20 mm).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMR | Other | Device: EMRStandard EMR technique |
| FTRD | Experimental | Device: over- the- scope full- thickness resection device (FTRD) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients ≥ 18 years
- adenomatous lesion 10-20 mm in size with expected difficulties regarding EMR (e.g. "non- lifting sign")
Key exclusion criteria (4 listed)
- patients < 18 years
- lesions > 20 mm in size
- high risk carcinomas ("deep submucosal carcinoma")
- American Society of Anesthesiologists (ASA) class IV and higher
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| over- the- scope full- thickness resection device (FTRD)Endoscopic resection of adenomatous lesions of the colon using the over- the- scope full- thickness resection device | Device | FTRD |
| EMRStandard endoscopic mucosal resection using a resection snare | Device | EMR |
Primary outcome
Success of resection
Time frame: 3 month
Success of resection: Complete resection (R0) according to clinical and/or histopathological assessment
1 secondary outcome
Duration of procedure
Time frame: up to 1 day (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 1 day)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2016.
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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.
Stefan von Delius, MD study director
II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing over- the- scope full- thickness resection device (FTRD) and EMR in people with Adenoma, run by Technical University of Munich at 1 site in Germany.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 21 Nov 2016. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Klare, MD (+49 89 4140 2251, peter.klare@lrz.tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of resection (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2016.