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

NCT07036432 | Completed DMC

• 1 other identifier: CIV-23-06-043373
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 5

Brief Summary

This study is looking at a new way to detect and monitor Barrett's esophagus (BE), a condition where the lining of the esophagus changes, increasing the risk of esophageal cancer. Currently, monitoring involves an endoscopy, where a camera is passed down the throat. While effective, endoscopy can be uncomfortable, uses significant healthcare resources, and sometimes involves sedation. This Swedish study explores a less invasive method called EndoSign®. EndoSign® is a small, swallowable capsule containing a sponge attached to a thin string. Patients swallow the capsule with water. It dissolves in the stomach over about 7 minutes, releasing the sponge. A trained nurse then gently pulls the sponge back up through the esophagus using the string, collecting cells along the way. The whole visit takes about 20-30 minutes. These cells are then sent to a lab to be checked for signs of BE and early changes (like TFF3, atypia, and p53) that might indicate a higher risk. The main goals of this study are: To see if using EndoSign® is practical (feasible) in several Swedish hospitals. To find out how patients feel about the EndoSign® test - is it acceptable and comfortable?. To check how safe the EndoSign® procedure is. To gather information needed to plan larger studies in the future. Who is participating? Around 70 adults (aged 18-84) across five Swedish hospitals, who have a confirmed diagnosis of BE and are already part of a surveillance program, are enrolled. Patients with certain alarm symptoms or those scheduled for immediate treatment are excluded. What happens in the study? Participants have a separate visit for the EndoSign® test, performed by a trained nurse. They also undergo their regular surveillance endoscopy (at least 90 days after the capsule test). Participants fill out questionnaires about their experience, comfort, and preferences after both procedures and again at 7 and 90 days. Potential Benefits \& Risks: EndoSign® could offer a simpler, less invasive, and potentially more comfortable way to monitor BE, which might reduce the need for some endoscopies. Early results show it is well-tolerated, with most patients preferring it over endoscopy, and has a high success rate and safety profile. Risks are low, with the most common being a temporary sore throat. Serious complications are considered very rare. This feasibility study aims to provide evidence on whether EndoSign® can be a valuable addition to BE surveillance in Sweden, potentially improving patient experience and resource use.

Conditions

Barrett Esophagus

Keywords

endosign; capsule sponge

Outcome Measures

Primary Outcomes (3)

• Technical Success Rate of the EndoSign® Procedure

  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.

  Perioperative/Periprocedural

• Patient-Reported Acceptability and Experience of the EndoSign® Procedure Compared to Gastroscopy

  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.

  Perioperative/Periprocedural and at 7 and 90-day follow-ups. (Both Visits)

• Safety of the EndoSign® Procedure

  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.

  Perioperative/Periprocedural and up to 90 days post-procedure.

Secondary Outcomes (4)

• Sample Adequacy of the EndoSign® Procedure

  Perioperative/Periprocedural

• Risk Stratification Performance of the EndoSign® Test

  Perioperative/Periprocedural

• Assessment of Patient-Reported Health-Related Quality of Life using EQ-5D-5L

  Perioperative/Periprocedural and at 7 and 90-day follow-ups.

• EndoSign® Capsule Swallowing Attempts

  Perioperative/Periprocedural

Other Outcomes (7)

• Mean Cost per procedure for Implementation of the EndoSign® Procedure

  Through study completion, average 8 months

• Mean Number of Supervised Procedures Required for a Healthcare Professional to Achieve Competency.

  Perioperative/Periprocedural

• Clinical Staff Acceptability of the EndoSign® Procedure Experience

  At the end of the recruitment period at each individual study site.

Study Arms (1)

Endosign

OTHER

Device: Endosign

Interventions

Endosign DEVICE

The intervention involves the EndoSign® Cell collection device (Cyted Ltd), a non-endoscopic method for esophageal sampling. Patients swallow a gelatine/HPMC capsule containing a sponge attached to a string. After \~7 minutes in the stomach for dissolution and sponge expansion, a trained nurse withdraws the sponge via the string, collecting cells. Optional throat anesthetic is offered. It can be performed without sedation in an outpatient clinic setting by a nurse. Samples undergo central analysis for TFF3, atypia, and p53, differing from standard biopsy histopathology. This study specifically evaluates its feasibility, acceptability, and nurse-led implementation in Swedish hospitals for Barrett's surveillance.

Endosign

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have a histopathologically confirmed diagnosis of Barrett's esophagus, specifically showing intestinal metaplasia.
• Patients must have at least a C0M1 Prague classification for their Barrett's esophagus.
• Patients must be under active monitoring with a surveillance endoscopy already planned to occur within the next 3 to 12 months.
• Patients must be between 18 and 84 years of age.

You may not qualify if:

• Patients scheduled for any endoscopic treatment (such as ablation) during their upcoming surveillance endoscopy.
• Patients experiencing alarm symptoms, including:
• Dysphagia (difficulty swallowing) and/or food sticking.
• Dyspepsia (indigestion) combined with weight loss.
• Dyspepsia combined with anaemia.
• Patients with a current diagnosis of an oropharyngeal, esophageal, or gastro-oesophageal tumour.
• Patients who have received treatment to their esophagus (e.g., endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD), radiofrequency ablation (RFA), or surgery) within the last two months.
• Patients known to have gastric or oesophageal varices or cirrhosis of the liver.
• Patients with any known anomaly of the oesophagus, such as webbing, pouches, or strictures.
• Patients who are unable to provide informed consent.
• Patients who have had a stroke or possess any other neurological disorder that has affected their swallowing ability.
• Patients who have experienced a myocardial infarction (heart attack) within the past 3 months.
• Patients who have undergone fundoplication or any other surgery involving the esophagus and proximal (upper) stomach.
• Patients currently using anti-trombotic medications which cannot be safely stopped temporarily for the procedure.

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (5)

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Skåne University Hospital

Lund, Sweden

Location

Vrinnevi Hospital

Norrköping, Sweden

Location

Ersta Hospital

Stockholm, Sweden

Location

Karolinska University Hospital

Stockholm, Sweden

Location

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 25, 2025
• Study Start: December 1, 2023
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: June 25, 2025

Record last verified: 2025-04

Locations

SE (5)