Introduction of EndoSign ® in Management of Barrett's Oesophagus - a Swedish Feasibility Study

Measures the rate of successfully completed EndoSign® procedures. Technical success is defined as a participant successfully swallowing the capsule (in a maximum of two attempts) and subsequent successful retrieval of the sponge by the nurse.

Measures and compares patient-reported outcomes for both the EndoSign® procedure and the surveillance gastroscopy. This includes Visual Analog Scale (VAS) scores (0-10) for discomfort and pain, which are measured immediately post-procedure and 15 minutes later for each respective procedure. It also assesses the patient's willingness to undergo each procedure again and their stated preference for future surveillance.

Patient willingness to undergo the EndoSign® procedure again. Patient preference for EndoSign® vs. endoscopy for future surveillance.

Incidence and rates of all Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs), and Serious Adverse Device Effects (SADEs) are recorded following the EndoSign® procedure. Events are classified by severity and relatedness.

The proportion of retrieved EndoSign® samples are deemed adequate for full laboratory analysis, including TFF3 expression, atypia assessment, and p53 immunohistochemistry. An inadequate sample may be due to insufficient columnar cells or other factors preventing full analysis.

Evaluation of the EndoSign® test's ability (using TFF3, atypia, p53, and clinical factors) to classify patients into low, moderate, and high-risk groups for harboring dysplasia. This includes calculating metrics such as Negative Predictive Value (NPV) for no dysplasia in low/moderate-risk groups and Positive Predictive Value (PPV) for dysplasia in the high-risk group, by comparing with endoscopic biopsy findings.

Measurement of general health-related quality of life using the EQ-5D-5L questionnaire, which assesses five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and includes a self-rated health Visual Analog Scale (VAS).

The number of attempts required for patients to successfully swallow the EndoSign® capsule. Swallowing success contributes to the overall technical feasibility.

The total cost of implementation, including materials (EndoSign® kit, sampling materials), staff time, and laboratory analysis (TFF3), is divided by the total number of completed procedures. The result is reported in SEK per procedure.

Mean number of EndoSign® procedures a nurse needs to perform under supervision before being deemed competent for independent practice.

Staff experience and acceptability is evaluated using a structured survey that includes both Likert scales and open-ended questions. The survey covers key domains such as the nurses' training, procedural experience, and implementation perspectives.

Measures the number of calendar days from the time a sample is sent from the hospital site to the laboratory in the UK until the test result is received

To assess the feasibility of recruitment by determining the proportion of eligible patients who consent to participate out of the total number of patients invited. This also includes quantifying the number of patients potentially available for recruitment from surveillance programs at each site. Recruitment feasibility is tracked via screening logs.

To evaluate the feasibility of the data collection methods, including response rates for questionnaires (e.g., VAS, preference questionnaires, EQ-5D) at baseline and follow-ups. This also includes tracking withdrawal and drop-out rates, and follow-up completion rates.

A descriptive analysis comparing the EndoSign® test results (TFF3 status, presence/absence of atypia, p53 expression status) with the histopathological findings from the patient's subsequent surveillance endoscopy biopsies (e.g., presence/absence of intestinal metaplasia, grade of dysplasia).