Introduction of EndoSign ® in Management of Barrett's Oesophagus - a Swedish Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 5
- 主要终点
- Technical Success Rate of the EndoSign® Procedure
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Technical Success Rate of the EndoSign® Procedure
时间窗: Perioperative/Periprocedural
Measures the rate of successfully completed EndoSign® procedures. Technical success is defined as a participant successfully swallowing the capsule (in a maximum of two attempts) and subsequent successful retrieval of the sponge by the nurse.
Patient-Reported Acceptability and Experience of the EndoSign® Procedure Compared to Gastroscopy
时间窗: Perioperative/Periprocedural and at 7 and 90-day follow-ups. (Both Visits)
Measures and compares patient-reported outcomes for both the EndoSign® procedure and the surveillance gastroscopy. This includes Visual Analog Scale (VAS) scores (0-10) for discomfort and pain, which are measured immediately post-procedure and 15 minutes later for each respective procedure. It also assesses the patient's willingness to undergo each procedure again and their stated preference for future surveillance. Patient willingness to undergo the EndoSign® procedure again. Patient preference for EndoSign® vs. endoscopy for future surveillance.
Safety of the EndoSign® Procedure
时间窗: Perioperative/Periprocedural and up to 90 days post-procedure.
Incidence and rates of all Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs), and Serious Adverse Device Effects (SADEs) are recorded following the EndoSign® procedure. Events are classified by severity and relatedness.
次要结局
- Sample Adequacy of the EndoSign® Procedure(Perioperative/Periprocedural)
- Risk Stratification Performance of the EndoSign® Test(Perioperative/Periprocedural)
- Assessment of Patient-Reported Health-Related Quality of Life using EQ-5D-5L(Perioperative/Periprocedural and at 7 and 90-day follow-ups.)
- EndoSign® Capsule Swallowing Attempts(Perioperative/Periprocedural)