Barrett EsophagusTOSS pilotNCT07490340
Trans-Oral Sampling as an Alternative Surveillance of Barrett's Esophagus Pilot
An observational study of Barrett Esophagus and Esophageal Adenocarcinoma, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett Esophagus, Esophageal Adenocarcinoma, Diagnosis
- What is being tested?
- trans oral sampling: endosign
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- 20 Oct 2023to 30 Jul 2026
- Phase
- Observational
- 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
Study population: : non dysplastic and dysplastic BE patients who will undergo endoscopy for surveillance or treatment
Who may be able to join
- - 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Amsterdam University Medical Centre, loc. VUmc
Amsterdam, North Holland, 1081HV
About this study
Official title: Trans-Oral Sampling as an Alternative Surveillance of Barrett's Esophagus Pilot: TOSS Pilot Study
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.
Read the detailed description
Esophageal adenocarcinoma (EAC) has a poor prognosis when diagnosed at an advanced stage. Yet when EAC is identified at an early stage, patients can be treated endoscopically, reducing mortality and morbidity. However, the early detection currently relies on endoscopic surveillance, since there is no proper alternative.
Barrett's esophagus is the precursor lesion to EAC. Currently, all patients with Barrett's esophagus (BE) will undergo several esophagogastroduodenoscopies (EGD) in their lifetime compliant with the surveillance strategy for early cancer detection. However, the annual risk of high-grade dysplasia (HGD) or EAC for the Barrett's surveillance population is less than 1 percent. An assessment of the prevalence of EAC and BE by age group using data from more than 5 million people showed that the relative number of Barrett patients has increased substantially. This increase is not based on enhanced screening, but with the recent rise of better available screening tools, the number of patients diagnosed with BE is also expected to increase in the coming years. Both culminating in a high-volume surveillance population.
A cost-effectiveness analysis showed that for most patients with a low risk of developing EAC, it is not cost-effective to continue with the current surveillance strategy that requires patients to come back for endoscopy after a fixed interval. In addition to the costs associated with endoscopy, patients suffer anxiety and distress before their surveillance endoscopy. BE patients have a worse quality of life due to the overestimation of their risk of cancer. Patients should receive a surveillance strategy more aligned with their risk profile. But since there is not an adequate substitute for endoscopic surveillance, the current strategy is being continued. To relieve low risk-patients and ensure adequate utilization of health care resources, there is a need for a reliable alternative.
The Endosign, a sample collection device in class I , is a well-investigated transoral sampling device that can be administered easily and safely. Studies have been performed investigating the Endosign, a sample collection device in class I, for screening purposes. The tissue collected with the inexpensive tool showed to be well assessable for identifying BE patients. Transoral sampling is well-tolerated by patients. The device has shown great efficacy and cost-effectiveness. Nevertheless, the potential use for surveillance and risk stratification remains unclear.
The aim of this study is to investigate whether the tissue collected by the Endosign could be utilized in the detection of early cancer and identification of patients at increased risk of neoplastic progression. With good quality sampling using the Endosign, transoral sampling could be the alternative for endoscopic surveillance of Barrett's esophagus.
- Conditions
- Barrett Esophagus, Esophageal Adenocarcinoma, Diagnosis
- Being tested
- trans oral sampling: endosign
- Keywords
- detection, surveillance, barretts esophagus, Esophageal Adenocarcinoma, dysplasia, Feasibility
- Medical subject headings
- Barrett Esophagus, Adenocarcinoma Of Esophagus, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trans oral sampling: endosignDiagnostic test
the endosign samples the esophagus by pulling the string on a sponge
| Study group | Role | What they receive |
|---|---|---|
| Cohor 1: | 30 BE patients referred for an endoscopic treatment of HGD or EAC. Receives: Diagnostic Test: trans oral sampling: endosign | |
| cohort 2 | 30 patients under standard BE surveillance without a diagnosis of HGD or EAC in previous 18 months Receives: Diagnostic Test: trans oral sampling: endosign |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
The amount of samples collected with the Endosign that contain columnar cells and are processed to clot preparations that are at least 5mm in size.
Measured: 1year
Secondary outcomes (5)
To investigate the practicability of the trans oral sample procedure
2 The number of successful Endosign study procedures. A successful Endosign procedure is defined as the retrieval of the specimen as intended and its preservation in a manner that makes it usable for processing making it a clot preparation of at least 5 mm in size.
Measured: 1 year
Concordance of dysplasia detection between capsule sponge and standard endoscopic biopsy
Presence or absence of dysplasia detected by capsule sponge and standard endoscopic biopsy in the same participant, with paired comparison analyzed using McNemar's test
Measured: 1 year
Concordance of intestinal metaplasia detection
Presence or absence of intestinal metaplasia detected by capsule sponge and standard endoscopic biopsy in the same participant, with paired comparison analyzed using McNemar's test
Measured: 1 year
Intraobserver agreement for histologic findings in Capsule Sponge Samples
Intraobserver agreement for histologic classification in capsule sponge samples, based on repeated assessment of the different Capsulesponge samples taken at baseline sampling, reported as Cohen's kappa coefficient
Measured: 1 year
Intraobserver agreement of genomic markers
Intraobserver agreement for genomic marker detection in capsule sponge samples, based on repeated analysis of the same capsule sponge samples obtained at baseline, reported as Cohen's kappa coefficient for categorical variables and intraclass correlation coefficient (ICC) for continuous variables
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start20 Oct 2023
- Primary completion20 Apr 2026 (estimated)
- Study completion30 Jul 2026 (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 Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacques J.G.H.M. Bergman, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07490340
- Sponsor's protocol ID
- NL84099.018.23
- Acronym
- TOSS pilot
- Status last verified
- Mar 2026
- First submitted
- 12 Oct 2023
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans-Oral Sampling as an Alternative Surveillance of Barrett's Esophagus Pilot: TOSS Pilot Study
- ClinicalTrials.gov ID
- NCT07490340
- Acronym / sponsor ID
- TOSS pilot / NL84099.018.23
- Conditions
- Barrett Esophagus, Esophageal Adenocarcinoma, Diagnosis
- Keywords
- detection, surveillance, barretts esophagus, Esophageal Adenocarcinoma, dysplasia, Feasibility
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 20 Apr 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 24 Mar 2026 (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.
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.
Detailed description
Esophageal adenocarcinoma (EAC) has a poor prognosis when diagnosed at an advanced stage. Yet when EAC is identified at an early stage, patients can be treated endoscopically, reducing mortality and morbidity. However, the early detection currently relies on endoscopic surveillance, since there is no proper alternative.
Barrett's esophagus is the precursor lesion to EAC. Currently, all patients with Barrett's esophagus (BE) will undergo several esophagogastroduodenoscopies (EGD) in their lifetime compliant with the surveillance strategy for early cancer detection. However, the annual risk of high-grade dysplasia (HGD) or EAC for the Barrett's surveillance population is less than 1 percent. An assessment of the prevalence of EAC and BE by age group using data from more than 5 million people showed that the relative number of Barrett patients has increased substantially. This increase is not based on enhanced screening, but with the recent rise of better available screening tools, the number of patients diagnosed with BE is also expected to increase in the coming years. Both culminating in a high-volume surveillance population.
A cost-effectiveness analysis showed that for most patients with a low risk of developing EAC, it is not cost-effective to continue with the current surveillance strategy that requires patients to come back for endoscopy after a fixed interval. In addition to the costs associated with endoscopy, patients suffer anxiety and distress before their surveillance endoscopy. BE patients have a worse quality of life due to the overestimation of their risk of cancer. Patients should receive a surveillance strategy more aligned with their risk profile. But since there is not an adequate substitute for endoscopic surveillance, the current strategy is being continued. To relieve low risk-patients and ensure adequate utilization of health care resources, there is a need for a reliable alternative.
The Endosign, a sample collection device in class I , is a well-investigated transoral sampling device that can be administered easily and safely. Studies have been performed investigating the Endosign, a sample collection device in class I, for screening purposes. The tissue collected with the inexpensive tool showed to be well assessable for identifying BE patients. Transoral sampling is well-tolerated by patients. The device has shown great efficacy and cost-effectiveness. Nevertheless, the potential use for surveillance and risk stratification remains unclear.
The aim of this study is to investigate whether the tissue collected by the Endosign could be utilized in the detection of early cancer and identification of patients at increased risk of neoplastic progression. With good quality sampling using the Endosign, transoral sampling could be the alternative for endoscopic surveillance of Barrett's esophagus.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohor 1: | – | Diagnostic Test: trans oral sampling: endosign30 BE patients referred for an endoscopic treatment of HGD or EAC. |
| cohort 2 | – | Diagnostic Test: trans oral sampling: endosign30 patients under standard BE surveillance without a diagnosis of HGD or EAC in previous 18 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- : non dysplastic and dysplastic BE patients who will undergo endoscopy for surveillance or treatment
Key inclusion criteria (6 listed)
- - 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| trans oral sampling: endosignthe endosign samples the esophagus by pulling the string on a sponge | Diagnostic test | Cohor 1:, cohort 2 |
Primary outcome
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.
Time frame: 1year
The amount of samples collected with the Endosign that contain columnar cells and are processed to clot preparations that are at least 5mm in size.
5 secondary outcomes
To investigate the practicability of the trans oral sample procedure
Time frame: 1 year
Concordance of dysplasia detection between capsule sponge and standard endoscopic biopsy
Time frame: 1 year
Concordance of intestinal metaplasia detection
Time frame: 1 year
Intraobserver agreement for histologic findings in Capsule Sponge Samples
Time frame: 1 year
Intraobserver agreement of genomic markers
Time frame: 1 year
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 24 Mar 2026.
- Individual participant dataSharing planned: No
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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 Barrett Esophagus and Esophageal Adenocarcinoma, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 6 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 24 Mar 2026. 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 Netherlands. 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?
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?
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. (time frame: 1year). 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 24 Mar 2026.