Trans-Oral Sampling as an Alternative Surveillance of Barrett's Esophagus Pilot (NCT07490340) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Trans-Oral Sampling as an Alternative Surveillance of Barrett's Esophagus Pilot
Netherlands60 participantsStarted 2023-10-20
Plain-language summary
The study aims to address the increasing incidence of esophageal cancer and Barrett's esophagus (BE) in the Western world by exploring a more efficient surveillance method. Esophageal adenocarcinoma (EAC) has a poor prognosis if diagnosed late, emphasizing the need for early detection strategies. Current surveillance methods, involving regular endoscopies, are burdensome and costly, particularly for low-risk patients. The study investigates the potential of the Endosign, a Trans Oral Sampling (TOS) device, as an alternative to endoscopic surveillance. The objective is to determine if Endosign can provide sufficient quality samples, containing columnar cells and clot preparations at least 5mm in size, thus offering a reliable substitute for endoscopic sampling. The study includes non-dysplastic and dysplastic BE patients undergoing surveillance or treatment and employs a single-center, prospective feasibility approach.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* \- Patients age: ≥ 18 years
* BE with a maximal extent of ≥4cm
* Willingness to undergo an esophagogastroduodenoscopy with sedation
* Cohort 1: Patients referred for endoscopic treatment of HGD or EAC
* Cohort 2: Patients with known BE without a diagnosis of HGD or EAC in the previous 18 months, undergoing endoscopic surveillance
* Ability to give written, informed consent and understand the responsibilities of participation
Exclusion Criteria:
* Patients within eight weeks after endoscopy with biopsies and/or ER
* History of esophageal or gastric surgery other than Nissen fundoplication
* History of esophageal ablation or dilation therapy
* Presence of esophageal varices and/or suspected portal hypertension
* Dysphagia/ swallowing disorders
* Pregnancy
* Patients with known or suspected anatomical abnormalities of the esophagus or stomach
* Patients taking anti-thrombotic drugs that cannot be temporarily discontinued
* Subject has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
to determine the number of sufficient quality samples obtained through the use of the Endosign, which could potentially serve as a substitute for endoscopic sampling.
Timeframe: 1year
Trial details
NCT IDNCT07490340
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)