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

NCT ID: NCT07036432

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2025-03-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Endosign

Group Type: OTHER

Endosign

Intervention Type: 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.

Interventions

Endosign

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vastra Gotaland Region

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sahlgrenska University Hospital

Gothenburg, , Sweden

Skåne University Hospital

Lund, , Sweden

Vrinnevi Hospital

Norrköping, , Sweden

Ersta Hospital

Stockholm, , Sweden

Karolinska University Hospital

Stockholm, , Sweden

Countries

Sweden

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

CIV-23-06-043373

Identifier Type: -

Identifier Source: org_study_id