Trans-Oral Sampling as an Alternative Surveillance of Barrett's Esophagus Pilot

NCT07490340 | Active Not Recruiting DMC FDA Device

• 1 other identifier: NL84099.018.23
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Barrett Esophagus; Esophageal Adenocarcinoma; Diagnosis

Keywords

detection; surveillance; barretts esophagus; Esophageal Adenocarcinoma; dysplasia; Feasibility

Outcome Measures

Primary Outcomes (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.

  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.

  1year

Secondary Outcomes (5)

• To investigate the practicability of the trans oral sample procedure

  1 year

• Concordance of dysplasia detection between capsule sponge and standard endoscopic biopsy

  1 year

• Concordance of intestinal metaplasia detection

  1 year

• Intraobserver agreement for histologic findings in Capsule Sponge Samples

  1 year

• Intraobserver agreement of genomic markers

  1 year

Study Arms (2)

Cohor 1:

30 BE patients referred for an endoscopic treatment of HGD or EAC.

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

Diagnostic Test: trans oral sampling: endosign

Interventions

trans oral sampling: endosign DIAGNOSTIC_TEST

the endosign samples the esophagus by pulling the string on a sponge

Cohor 1:; cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

: non dysplastic and dysplastic BE patients who will undergo endoscopy for surveillance or treatment

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Amsterdam University Medical Centre, loc. VUmc

Amsterdam, North Holland, 1081HV, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

samples of the barrett mucosa in the oesphaghus collected with a trans oral sampling device

MeSH Terms

Conditions

Barrett Esophagus; Adenocarcinoma Of Esophagus; Disease

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Endoscopy Department, prof.dr. J.J.G.H.M. Bergman

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: March 24, 2026
• Study Start: October 20, 2023
• Primary Completion: April 20, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)