Barrett EsophagusENDOBARRETTNCT04867590
A Study Comparing the Effectiveness of EndoRotor Versus Radiofrequency in Treating Barrett's Esophagus
A study testing Endorotor and Radiofrequency in people with Barrett Esophagus and Dysplasia, run by University Hospital, Angers at 17 sites in France.
Trial summary
Barrett Esophagus is a common pathology, with an estimated prevalence of 1.6% at risk of progression to precancerous mucosa (low to high grade dysplasia). The incidence of adenocarcinoma on BE is 0.5% per year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett Esophagus, Dysplasia
- What is being tested?
- Endorotor and Radiofrequency
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 17 sitesFrance
- Study dates
- 25 Mar 2022to 25 Jul 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adult patients presenting Barrett's esophagus of a size between 2 cm and 6 cm in the height of the longest tonguea with low to high grade dysplasia that is histologically proven or with a superficial non-invasive adenocarcinoma that has been resected a The total height of the BE is evaluated according to the Prague classification, with the height of the circumferential segment between 0 cm (non-circumferential segment) and 6 cm (segment shaped like a full sleeve for 6 cm), referred to as C0 to C6, and the height of the longest tongue between 2 cm and 6 cm (M2- M6).
- Patients must have signed the consent form in order to participate in the study
- Patients are pre-included (signature of consent) before the histological confirmation of dysplasiab and/or superficial non-invasive adenocarcinoma that allows the patient to be included in the study.
Who cannot join
- Individuals over 85 years old
- Women who are pregnant, breastfeeding or in labour
- Individuals in detention through judicial or administrative decision
- Individuals who are the subject of psychiatric treatment under duress
- Individuals who are subjects of legal protection measures
- Individuals who are in no state to give their consent
Show all 17Show fewer
- Individuals who do not understand French or do not know how to read
- Individuals who are not part of a social security program or benefit from such a scheme
- Those with active peptic and/or radiation-induced or complicated esophagitis at the time of treatment
- Presence of a visible lesion that is suspected to be esophageal cancer confirmed by biopsies
- Anterior resection of invasive adenocarcinoma using endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) with invasion of the lateral and/or deep margin, adenocarcinoma of poorly differentiated characteristics or sub-mucosal invasion > 500µm (pT1b)
- All preliminary ablation treatments or dilation for esophageal stenosis
- Significant esophageal stenosis: cannot be passed with a standard gastroscope
- Presence of esophageal varices or portal hypertension
- Anticoagulant treatment that cannot be stopped before the intervention (excluding 100 mg maximum per day of aspirin in single-drug treatment) or any haemostasis problems that cannot be corrected
- Having a contraindication regarding anaesthesia
- Patients incapable of taking proton pump inhibitors (PPIs) orally.
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
France17 sites, 15 recruiting
- Recruiting
University Hospital of Besançon
Besançon
Justin FAURE
- Not yet recruiting
University Hospital of Brest
Brest
Franck CHOLET, Ph.D.
- Recruiting
University Hospital of Tours
Chambray-lès-Tours
Driffa MOUSSATA, Ph.D.
- Recruiting
University Hospital of Dijon
Dijon
Thiabult DEGAND
- Recruiting
University Hospital of Lille
Lille
Julien BRANCHE, Ph.D.
- Recruiting
University Hospital of Limoges
Limoges
Jérémie JACQUES, Ph.D.
- Recruiting
Edouard Herriot Hospital
Lyon
Mathieu PIOCHE, Ph.D.
- Recruiting
University Hospital of Montpellier
Montpellier
Laurent MONINO
- Recruiting
University Hospital of Nancy
Nancy
Jean-Baptiste CHEVAUX
- Recruiting
University Hospital of Nantes
Nantes
Emmanuel CORON, Ph.D.
- Not yet recruiting
University Hospital of Nice
Nice
Geoffroy VANBIERVLIET, Ph.D.
- Active, not recruiting
Cochin Hospital
Paris
- Withdrawn
Georges Pompidou European Hospital
Paris
- Recruiting
University Hospital of Bordeaux
Pessac
Arthur BERGER, Ph.D.
- Not yet recruiting
University Hospital of Poitiers
Poitiers
Thierry BARRIOZ, Ph.D.
- Not yet recruiting
University Hospital of Rennes
Rennes
Timothée WALLENHORST, Ph.D.
- Recruiting
UNiversity Hospital of Toulouse
Toulouse
Adrian CULETTO
About this study
Official title: A Controlled, Randomised Multicenter Study Comparing the Effectiveness of EndoRotor (New Treatment Technique) Versus Radiofrequency (Reference Technique) in Treating Barrett's Esophagus Complicated by Dysplasia
Barrett Esophagus is a common pathology, with an estimated prevalence of 1.6% at risk of progression to precancerous mucosa (low to high grade dysplasia). The incidence of adenocarcinoma on BE is 0.5% per year. In the event of dysplasia or cancer in situ, it is currently recommended at international and particularly European level to eradicate BE. The treatment techniques used to date carry out thermal destruction of the BE, in particular by radiofrequency. Eradication of dysplasia is achieved in 81% to 100% and disappearance of BE in 73% to 87% of cases. It requires an average of 3 destruction sessions. RF does not allow histological analysis after destruction of BE, but the risk of progression to neoplasia is estimated at 7.8/1000 persons per year. This risk could be due to the presence of glands buried in the esophageal mucosa. Indeed, these glands are not destroyed by thermal ablation methods, and remain invisible during endoscopic controls.
A new treatment technique using the Endorotor® system allows mechanical resection of the entire mucosa in one session of treatment. In addition, the cost of these thermal destruction techniques currently limits their wider diffusion. It is therefore legitimate to propose a less expensive and probably more effective alternative technique.
- Conditions
- Barrett Esophagus, Dysplasia
- Being tested
- Endorotor, Radiofrequency
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndorotorDevice
The treatment itself is preceded by a sub-mucosa saline and adrenalin solution injection administered by an endoscopic sclerotherapy needle lifting the submucosa and thus reducing the risk of perforation and hemorrhage.
The interventional tool is then applied tangentially to be brought into contact with the lifted mucosa, visual monitored by endoscope. The aspiration and sectioning system is activated by use of a pedal and a generator specially made for the system, used in every procedure. The entire surface area of the targeted mucosa must be covered by the probe. The residual tissue is then removed via the aspiration system and caught by a filter. The specimens are then easily retrievable at the end of the procedure and can be stored in formalin fixing solution for histological analysis.
RadiofrequencyDevice
Endoscopic treatment using the HALO® 360 or 90 system is a thermal method for destroying the superficial mucosa. An initial debridement of the mucosal deposits is carried out by application of acetylcysteine in spray form with a spray catheter on the entire mucosal surface to be treated and then rinsed with water after a minute of application time.
For circumferential BEs, a single-use 360 Express® probe is used to make it possible to size the diameter of the esophagus and the treatment used. The length of the treatment area is 5 cm and several points of impact can be achieved by overlapping the catheter at two consecutive heights, with the zone spanned measuring one centimeter, in order to cover the entire pathological area requiring treatment.
For non-circumferential lesions a "palette" applicator is used in a variety of sizes, and in this context no sizing of the esophagus is required.
| Study group | Role | What they receive |
|---|---|---|
| EndoRotor | Experimental | The ENDOROTOR is a new system for the resection of superficial lesions within the digestive tract and composed of a reusable generator, a single-use probe and additional accessories.
The device is used in the resection of mucosa in the digestive tract: flat or slightly raised lesions in the digestive mucosa, or treatment of the lateral margins following a resection carried out using another technique.
Resected tissue is aspirated away through a rotating catheter: the cutting and removal of tissue as well as the collection of specimens are combined into one act. Receives: Device: Endorotor |
| Radiofrequency | Active comparator | Endoscopic treatment using the HALO® 360 or 90 system is a thermal ablation system for superficial mucosa. First and foremost, the examination includes an endoscopy to locate the upper limits of the BE and its distribution, so as to choose the most appropriate type of probe. An initial debridement of the mucosal deposits is carried out by application of acetylcysteine in spray form with a spray catheter on the entire mucosal surface to be treated and then rinsed with water after a minute of application time. Receives: Device: Radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of full eradication of Barrett esophagus (metaplasia), which is defined by the absence of residual Barrett esophagus in the check-up endocopy after 3 months
To evaluate, 3 months after the first endoscopic treatment, the effectiveness of Endorotor treatment versus Radiofrequency in the elimination of Barrett esophagus complicated with dysplasia or adenocarcinoma.
Measured: 3 months after the endoscopic treatment
Secondary outcomes (15)
Effectiveness assessment defined by the absence of dysplasia on all systematic esophageal biopsies confirmed by an anatomical pathological reading on site
To compare the effectiveness of endoscopic Endorotor treatment versus Radiofrequency esophageal treatment on eradication of dysplasia 3 months after the initial endoscopic treatment
Measured: 3 months after the initial endoscopic treatment
Effectiveness assessment defined by the absence of dysplasia on all systematic oesophageal biopsies confirmed by an anatomical pathological reading on site
To compare the effectiveness of endoscopic Endorotor treatment versus Radiofrequency esophageal treatment on eradication of dysplasia 12 months after the initial treatment
Measured: 12 months after the initial treatment
Effectiveness assessment defined by the area regression of Barrett esophagus between the pre-treatment evaluation and the follow-up at 3 months is evaluated using a visual endoscopic scale of the area Barrett esophagus regression and video analysis
To compare the effectiveness of endoscopic Endorotor treatment versus Radiofrequency esophageal treatment on the area of Barrett esophagus regression 3 months after the initial treatment
Measured: 3 months after the initial endoscopic treatment
Effectiveness assessment defined by the area regression of Barrett esophagus between the pre-treatment evaluation and the follow-up at 12 months is evaluated using a visual endoscopic scale of the area Barrett esophagus regression and video analysis
To compare the effectiveness of endoscopic Endorotor treatment versus Radiofrequency esophageal treatment on the area of Barrett esophagus regression 12 months after the initial treatment
Measured: 12 months after the initial treatment
Effectiveness assessment defined by the rate of eradicating Barrett esophagus 12 months after the initial endoscopic treatment which is confirmed by the absence of Barrett esophagus lesions on biopsies
To compare the effectiveness of endoscopic Endorotor treatment versus Radiofrequency esophageal treatment on eradication of Barrett esophagus 12 months after the first treatment
Measured: 12 months after the first treatment
Effectiveness assessment defined by the number of additional treatment sessions carried out using radiofrequency to achieve complete eradication of Barrett esophagus at 12 months, after initial endoscopic treatment
To compare the effectiveness of endoscopic Endorotor treatment versus Radiofrequency esophageal treatment to determine the number of additional sessions carried out to achieve complete eradication at 12 months after the initial treatment
Measured: 12 months after the initial treatment
Safety assessment defined by the discomfort score is recorded in a log over as well as dysphagia score and pain evaluation in first 30 days following the initial procedure and during the clinical evaluating
After 3 months, evaluating the safety of endoscopic treatment with Endorotor, compared to the reference treatment with esophageal radiofrequency to evaluating clinical tolerance
Measured: 3 months after the initial endoscopic treatment
Safety assessment defined by the serious adverse events after treatment and then at day 2, day 15, day 30 and 3 months after the initial endoscopic treatment are classed in four levels of severity based on the level of hospitalization, in accordance with
After 3 months, evaluating the safety of endoscopic treatment with Endorotor, compared to the reference treatment with esophageal radiofrequency to register the rate of serious adverse events
Measured: 3 months after the initial treatment
Safety assessment defined by esophageal stenosis that cannot be passed by a standard gastroscope of 10 mm in diameter.
After 3 months, evaluating the safety of endoscopic treatment with Endorotor, compared to the reference treatment with esophageal radiofrequency to evaluate the rate of esophageal stenosis
Measured: 3 months after the initial treatment
Evaluating the benefit of anatomo pathological analysis of resected tissue after treatment using ENDOROTOR defined by the quality of the anatomical pathological analysis for the samples taken during treatment is determined through a centralised readin
Evaluate benefits of histological information obtained with Endorotor to evaluate the quality of anatomical pathology analysis of resected samples using Endorotor
Measured: 12 months after the first treatment
Evaluating the benefit of anatomo pathological analysis of resected tissue after treatment using ENDOROTOR defined by the percentage of patients for whom the analyses of resected tissue enable the discovery of a dysplasia or adenocarcinoma
Determine percentage of patients for whom the analysis of resected tissue will enable the discovery of a dysplasia or adenocarcinoma, ignored on the first biopsies
Measured: 12 months after the first treatment
Evaluating the benefit of anatomo pathological analysis of resected tissue after treatment using ENDOROTOR defined by the percentage of patients for whom the analyses of resected tissue enable a change in the follow-up plan
Determine percentage of patients for whom the analysis of resected tissue will enable a change in their follow up
Measured: 12 months after the first treatment
Evaluating the efficiency defined by the incremental cost-utility ratio
To assess and compare the efficiency of endoscopic EndoRotor treatment against radiofrequency treatment in the elimination of Barrett's eosophagus in term of cost per Quality Adjusted Life Years gained
Measured: 12 months after the first treatment
Evaluating the efficiency defined by the incremental cost-effectiveness ratio
To assess and compare the efficiency of endoscopic EndoRotor treatment against radiofrequency treatment in the elimination of Barrett's eosophagus in term of cost per rate of eradicating barrett's eosophagus
Measured: 12 months after the first treatment
Build a model to predict incomplete response for eradication of Barrett's eosophagus on the basis of each independent predictor coefficient in the multivariate regression logistic model
Build a predictive model of incomplete response to eradication of Barrett's eosophagus
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start25 Mar 2022
- Primary completion25 Jul 2031 (estimated)
- Study completion25 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett EsophagusStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Elodie CESBRON-METIVIER, Ph.D., Principal investigator, UH Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04867590
- Sponsor's protocol ID
- 2020-A00975-34
- Acronym
- ENDOBARRETT
- Status last verified
- Jun 2026
- First submitted
- 27 Apr 2021
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled, Randomised Multicenter Study Comparing the Effectiveness of EndoRotor (New Treatment Technique) Versus Radiofrequency (Reference Technique) in Treating Barrett's Esophagus Complicated by Dysplasia
- ClinicalTrials.gov ID
- NCT04867590
- Acronym / sponsor ID
- ENDOBARRETT / 2020-A00975-34
- Conditions
- Barrett Esophagus, Dysplasia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 25 Mar 2022 (actual)
- Primary completion
- 25 Jul 2031 (estimated)
- Study completion
- 25 Jul 2031 (estimated)
- First posted
- 30 Apr 2021 (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.
Barrett Esophagus is a common pathology, with an estimated prevalence of 1.6% at risk of progression to precancerous mucosa (low to high grade dysplasia). The incidence of adenocarcinoma on BE is 0.5% per year. In the event of dysplasia or cancer in situ, it is currently recommended at international and particularly European level to eradicate BE. The treatment techniques used to date carry out thermal destruction of the BE, in particular by radiofrequency. Eradication of dysplasia is achieved in 81% to 100% and disappearance of BE in 73% to 87% of cases. It requires an average of 3 destruction sessions. RF does not allow histological analysis after destruction of BE, but the risk of progression to neoplasia is estimated at 7.8/1000 persons per year. This risk could be due to the presence of glands buried in the esophageal mucosa. Indeed, these glands are not destroyed by thermal ablation methods, and remain invisible during endoscopic controls.
A new treatment technique using the Endorotor® system allows mechanical resection of the entire mucosa in one session of treatment. In addition, the cost of these thermal destruction techniques currently limits their wider diffusion. It is therefore legitimate to propose a less expensive and probably more effective alternative technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EndoRotor | Experimental | Device: EndorotorThe ENDOROTOR is a new system for the resection of superficial lesions within the digestive tract and composed of a reusable generator, a single-use probe and additional accessories. The device is used in the resection of mucosa in the digestive tract: flat or slightly raised lesions in the digestive mucosa, or treatment of the lateral margins following a resection carried out using another technique. Resected tissue is aspirated away through a rotating catheter: the cutting and removal of tissue as well as the collection of specimens are combined into one act. |
| Radiofrequency | Active comparator | Device: RadiofrequencyEndoscopic treatment using the HALO® 360 or 90 system is a thermal ablation system for superficial mucosa. First and foremost, the examination includes an endoscopy to locate the upper limits of the BE and its distribution, so as to choose the most appropriate type of probe. An initial debridement of the mucosal deposits is carried out by application of acetylcysteine in spray form with a spray catheter on the entire mucosal surface to be treated and then rinsed with water after a minute of application time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients presenting Barrett's esophagus of a size between 2 cm and 6 cm in the height of the longest tonguea with low to high grade dysplasia that is histologically proven or with a superficial non-invasive adenocarcinoma that has been resected a The total height of the BE is evaluated according to the Prague classification, with the height of the circumferential segment between 0 cm (non-circumferential segment) and 6 cm (segment shaped like a full sleeve for 6 cm), referred to as C0 to C6, and the height of the longest tongue between 2 cm and 6 cm (M2- M6).
- Patients must have signed the consent form in order to participate in the study
- Patients are pre-included (signature of consent) before the histological confirmation of dysplasiab and/or superficial non-invasive adenocarcinoma that allows the patient to be included in the study.
Key exclusion criteria (17 listed)
- Individuals over 85 years old
- Women who are pregnant, breastfeeding or in labour
- Individuals in detention through judicial or administrative decision
- Individuals who are the subject of psychiatric treatment under duress
- Individuals who are subjects of legal protection measures
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 |
|---|---|---|
| EndorotorThe treatment itself is preceded by a sub-mucosa saline and adrenalin solution injection administered by an endoscopic sclerotherapy needle lifting the submucosa and thus reducing the risk of perforation and hemorrhage. The interventional tool is then applied tangentially to be brought into contact with the lifted mucosa, visual monitored by endoscope. The aspiration and sectioning system is activated by use of a pedal and a generator specially made for the system, used in every procedure. The entire surface area of the targeted mucosa must be covered by the probe. The residual tissue is then removed via the aspiration system and caught by a filter. The specimens are then easily retrievable at the end of the procedure and can be stored in formalin fixing solution for histological analysis. | Device | EndoRotor |
| RadiofrequencyEndoscopic treatment using the HALO® 360 or 90 system is a thermal method for destroying the superficial mucosa. An initial debridement of the mucosal deposits is carried out by application of acetylcysteine in spray form with a spray catheter on the entire mucosal surface to be treated and then rinsed with water after a minute of application time. For circumferential BEs, a single-use 360 Express® probe is used to make it possible to size the diameter of the esophagus and the treatment used. The length of the treatment area is 5 cm and several points of impact can be achieved by overlapping the catheter at two consecutive heights, with the zone spanned measuring one centimeter, in order to cover the entire pathological area requiring treatment. For non-circumferential lesions a "palette" applicator is used in a variety of sizes, and in this context no sizing of the esophagus is required. | Device | Radiofrequency |
Primary outcome
The rate of full eradication of Barrett esophagus (metaplasia), which is defined by the absence of residual Barrett esophagus in the check-up endocopy after 3 months
Time frame: 3 months after the endoscopic treatment
To evaluate, 3 months after the first endoscopic treatment, the effectiveness of Endorotor treatment versus Radiofrequency in the elimination of Barrett esophagus complicated with dysplasia or adenocarcinoma.
15 secondary outcomes
Effectiveness assessment defined by the absence of dysplasia on all systematic esophageal biopsies confirmed by an anatomical pathological reading on site
Time frame: 3 months after the initial endoscopic treatment
Effectiveness assessment defined by the absence of dysplasia on all systematic oesophageal biopsies confirmed by an anatomical pathological reading on site
Time frame: 12 months after the initial treatment
Effectiveness assessment defined by the area regression of Barrett esophagus between the pre-treatment evaluation and the follow-up at 3 months is evaluated using a visual endoscopic scale of the area Barrett esophagus regression and video analysis
Time frame: 3 months after the initial endoscopic treatment
Effectiveness assessment defined by the area regression of Barrett esophagus between the pre-treatment evaluation and the follow-up at 12 months is evaluated using a visual endoscopic scale of the area Barrett esophagus regression and video analysis
Time frame: 12 months after the initial treatment
Effectiveness assessment defined by the rate of eradicating Barrett esophagus 12 months after the initial endoscopic treatment which is confirmed by the absence of Barrett esophagus lesions on biopsies
Time frame: 12 months after the first treatment
Effectiveness assessment defined by the number of additional treatment sessions carried out using radiofrequency to achieve complete eradication of Barrett esophagus at 12 months, after initial endoscopic treatment
Time frame: 12 months after the initial treatment
Safety assessment defined by the discomfort score is recorded in a log over as well as dysphagia score and pain evaluation in first 30 days following the initial procedure and during the clinical evaluating
Time frame: 3 months after the initial endoscopic treatment
Safety assessment defined by the serious adverse events after treatment and then at day 2, day 15, day 30 and 3 months after the initial endoscopic treatment are classed in four levels of severity based on the level of hospitalization, in accordance with
Time frame: 3 months after the initial treatment
Safety assessment defined by esophageal stenosis that cannot be passed by a standard gastroscope of 10 mm in diameter.
Time frame: 3 months after the initial treatment
Evaluating the benefit of anatomo pathological analysis of resected tissue after treatment using ENDOROTOR defined by the quality of the anatomical pathological analysis for the samples taken during treatment is determined through a centralised readin
Time frame: 12 months after the first treatment
Evaluating the benefit of anatomo pathological analysis of resected tissue after treatment using ENDOROTOR defined by the percentage of patients for whom the analyses of resected tissue enable the discovery of a dysplasia or adenocarcinoma
Time frame: 12 months after the first treatment
Evaluating the benefit of anatomo pathological analysis of resected tissue after treatment using ENDOROTOR defined by the percentage of patients for whom the analyses of resected tissue enable a change in the follow-up plan
Time frame: 12 months after the first treatment
Evaluating the efficiency defined by the incremental cost-utility ratio
Time frame: 12 months after the first treatment
Evaluating the efficiency defined by the incremental cost-effectiveness ratio
Time frame: 12 months after the first treatment
Build a model to predict incomplete response for eradication of Barrett's eosophagus on the basis of each independent predictor coefficient in the multivariate regression logistic model
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Barrett Esophagus
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
RecruitingPhase 4
Efficacy of Potassium-Competitive Acid Blockers in Barrett's Esophagus (PCAB BE Study)
Barrett Esophagus
RecruitingObservational study
"Less-is-more in Barrett-surveillance" Care Evaluation of Barrett's Patients With Low-Risk in Whom Endoscopic Surveillance is Stopped. The BLISS Project.
Barrett Esophagus, Barrett Esophagus Adenocarcinoma
Not yet recruitingObservational study
Lucid BE Biomarkers Study
Barrett's Esophagus, Barrett's Esophagus With Dysplasia
RecruitingObservational study
Impact of RFA on Esophageal Distensibility and Mucosal Impedance
Dysplastic Barrett's Esophagus, Radiofrequency Ablation
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.
Elodie CESBRON-METIVIER, Ph.D. principal investigator
UH Angers
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endorotor and Radiofrequency in people with Barrett Esophagus and Dysplasia, run by University Hospital, Angers at 17 sites in France.
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 3 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elodie CESBRON-METIVIER, Ph.D. (+33241353148, elcesbronmetivier@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of full eradication of Barrett esophagus (metaplasia), which is defined by the absence of residual Barrett esophagus in the check-up endocopy after 3 months (time frame: 3 months after the endoscopic treatment). 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 30 Jun 2026.