NCT07036432

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Vastra Gotaland Region · Other Government
• Sex: All
• Age: 18 Years – 84 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2023-12-01
• Primary completion: 2025-03-01
• Completion: 2025-03-01
• First posted: 2025-06-25
• Last updated: 2025-06-25

Locations

5 sites across 1 country: Sweden