Minimally-Invasive Detection of Barrett's Esophagus and Barrett's Esophagus Related Dysplasia/Carcinoma by a Sponge on String Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 242
- 试验地点
- 11
- 主要终点
- Number of Subjects That Would Have This Procedure Again
研究概览
简要总结
This study is being done to collect data on the potential use of a sponge on a string device as a non-invasive tool in evaluating patients with Barrett's Esophagus compared to healthy controls.
详细描述
This study will be conducted in two phases: Phase 1 and Phase 2. Phase 1 will consist of determining the most optimal sponge on a string design (25 mm sponge 20 pores/inch or 25 mm sponge 10 pores/inch) chosen based on participant acceptance, tolerability, mucosal irritation and DNA yield, using a randomized factorial design pilot trial. Participants will first undergo the sponge on a string test followed by clinical endoscopy. Following completion of Phase 1 trial, the most optimal sponge on a string configuration will be chosen for Phase 2. Phase 2 will be conducted using a single size sponge with the same porosity configuration selected from Phase 1. Study procedures, testing and follow up will be the same as Phase 1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects with known Barrett's Esophagus (BE).
- •Patients with a BE segment ≥ 1cm in maximal extent endoscopically.
- •Histology showing evidence of intestinal metaplasia with or without presence of dysplasia.
- •Undergoing clinically indicated endoscopy. Subjects without known evidence of BE - Undergoing clinically indicated diagnostic endoscopy
排除标准
- •Subjects with known BE.
- •Patients with prior history of ablation (photodynamic therapy, radiofrequency ablation, cryotherapy, argon plasma coagulation). Patients with history of endoscopic mucosal resection alone will not be excluded.
- •Patients with history of esophageal resection for esophageal carcinoma. Subjects with or without known evidence of BE (on history or review of medical records).
- •Pregnant or lactating females.
- •Patients who are unable to consent.
- •Patients with current history of eosinophilic esophagitis, achalasia or uninvestigated dysphagia.
- •Patients on oral anticoagulation including Coumadin, Warfarin.
- •Patients on antiplatelet agents including Clopidogrel, unless discontinued for 3 days prior to the sponge procedure.
- •Patients on oral thrombin inhibitors including Dabigatran and oral factor X a inhibitors such as rivaroxaban, apixaban and edoxaban, unless discontinued for 3 days prior to the sponge procedure.
- •Patients with history of known varices or cirrhosis.
- •Patients with history of esophageal resection for esophageal carcinoma.
- •Patients with congenital or acquired bleeding diatheses.
- •Patients with a history of esophageal squamous dysplasia.
- •Patient has known carcinoma of the foregut (pancreatic, bile duct, ampullary, stomach, or duodenum) within 5 years prior to study enrollment.
结局指标
主要结局
Number of Subjects That Would Have This Procedure Again
时间窗: Within 24 hours of the capsule sponge administration
Number of subjects that answered yes to the self-reported question "Would you choose to have this procedure again to screen for Barrett's esophagus?"
Tolerability of Swallowing the Sponge Device
时间窗: Within 24 hours of the capsule sponge administration
Measured using a self-reported 5-item tolerability assessment rating discomfort during the procedure on a Likert scale of 0-10; 10 representing the "worst experience" and 0 the "best experience." This scale allows a comprehensive and individual assessment of the degree of pain, choking, gagging, anxiety and overall experienced during the procedure.
Mucosal Irritation
时间窗: Within 24 hours of the capsule sponge administration
Measured using a mucosal injury score (ranging from 1=no trauma to 5=severe) was scored from video recordings of the subsequent endoscopy conducted
DNA Yield
时间窗: Within 24 hours of the capsule sponge administration
Total amount of DNA obtained from esophageal cytology specimens collected by the capsule sponge devices.
次要结局
- Sensitivity of Barrett's Dysplasia Detection(Within 24 hours of the capsule sponge administration)
- Specificity of Barrett's Dysplasia Detection(Within 24 hours of the capsule sponge administration)
研究者
Prasad G. Iyer
Principal Investigator
Mayo Clinic