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

Vastra Gotaland Region

Status

Completed

Conditions

Barrett Esophagus

Treatments

Device: Endosign

Study type

Interventional

Funder types

Other

Identifiers

NCT07036432

CIV-23-06-043373

Details and patient eligibility

About

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.

Enrollment

70 patients

Sex

All

Ages

18 to 84 years old

Volunteers

No Healthy Volunteers

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.