Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2026-01-02 @ 6:44 AM
Study NCT ID:
NCT07036432
Status:
COMPLETED
Last Update Posted:
2025-06-25
First Post:
2025-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Introduction of EndoSign ® in Management of Barrett's Oesophagus - a Swedish Feasibility Study
Sponsor:
Vastra Gotaland Region
Organization:
Study Overview
Official Title:
Introduction of EndoSign ® in Management of Barrett's Oesophagus - a Swedish Feasibility Study
Status:
COMPLETED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: