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

NACompletedINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

December 1, 2023

Primary Completion Date

March 1, 2025

Study Completion Date

March 1, 2025

Conditions
Barrett Esophagus
Interventions
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."

Trial Locations (5)

Unknown

Sahlgrenska University Hospital, Gothenburg

Skåne University Hospital, Lund

Vrinnevi Hospital, Norrköping

Ersta Hospital, Stockholm

Karolinska University Hospital, Stockholm

All Listed Sponsors
lead

Vastra Gotaland Region

OTHER_GOV

NCT07036432 - Introduction of EndoSign ® in Management of Barrett's Oesophagus - a Swedish Feasibility Study | Biotech Hunter | Biotech Hunter