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Compares treatment options for Barrett Esophagus
Official title A Study Comparing the Effectiveness of EndoRotor Versus Radiofrequency in Treating Barrett's Esophagus
ClinicalTrials.gov ID: NCT04867590
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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 people of legal protection measures
- Individuals who are in no state to give their consent
See the full eligibility criteria
- 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...
- 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.
- 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 people of legal protection measures
- Individuals who are in no state to give their consent
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Besançon, France
- Brest, France
- Chambray-lès-Tours, France
- Dijon, France
- Lille, France
- Limoges, France
- Lyon, France
- Montpellier, France
- Nancy, France
- Nantes, France
- Nice, France
- Paris, France
- Pessac, France
- Poitiers, France
- Rennes, France
- Toulouse, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Besançon, France; Brest, France; Chambray-lès-Tours, France; Dijon, France; Lille, France; Limoges, France and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.