Clinical Trial to Evaluate Safety and Dose Response Using the C2 CryoBalloon™ Swipe Ablation System for the Treatment of Barrett's Esophagus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 3
- 主要终点
- Efficacy: Percent Eradication by therapeutic dose
研究概览
简要总结
The primary objective is to determine the safety and efficacy of the C2 CryoBalloon™ Swipe Ablation System ("CryoBalloon Swipe") used at increasing doses.
详细描述
The procedure will be performed on an outpatient basis, and the CryoBalloon Swipe will be used for all ablations following the instructions for use provided with the product.
Patients who meet the eligibility criteria will be assigned to one of the treatment groups and doses, depending on the order of their enrollment:
In phase I, the first 6 patients will be treated with Dose 1 (lowest).
All patients will have to undergo 8 week (±1 week) follow-up EGD to evaluate efficacy of the dose before the study continues.
If the follow-up endoscopies show that Dose 1 eradicates ≥80% of the treated BE (by median percentage) and no SAE's are reported, this dose is defined as the therapeutic dose and enrollment will proceed to phase II.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with flat-type (Paris type 0-IIb) BE esophagus, with an indication for ablation therapy, meaning:
- •Diagnosis of LGD or HGD in BE (confirmed by baseline histopathological analysis), OR
- •Residual BE with any grade of dysplasia after endoscopic resection
- •Prague Classification Score C≤3
- •Patients should be ablative-naïve (no previous ablation therapy of the esophagus)
- •Older than 18 years of age at time of consent
- •Operable per institution's standards
- •Provides written informed consent on the IRB-approved informed consent form
- •Willing and able to comply with follow-up requirements
排除标准
- •Esophageal stenosis or stricture preventing advancement of a therapeutic endoscope.
- •Any endoscopically visualized lesion such as ulcers, masses or nodules.
- •History of locally advanced (>T1a) esophageal cancer
- •History of esophageal varices
- •Prior distal esophagectomy
- •Active esophagitis LA grade B or higher
- •Severe medical comorbidities precluding endoscopy
- •Uncontrolled coagulopathy
- •Pregnant or planning to become pregnant during period of study
- •Patient refuses or is unable to provide written informed consent
- •Participation in another study with investigational drug within the 30 days preceding or during the present study
- •General poor health, multiple co-morbidities placing the patient at risk or otherwise unsuitable for trial participation
结局指标
主要结局
Efficacy: Percent Eradication by therapeutic dose
时间窗: 8 weeks
Eradication percentage of BE confirmed by histological evidence of eradication of BE, after treatment with the therapeutic dose.
Dose-related SAEs
时间窗: 30 days
Safety will be evaluated by the incidence of Dose-related SAEs. Dose-related SAEs include pain in the treatment area, or any stricture (symptomatic or asymptomatic) preventing passage of the diagnostic endoscope at follow-up EGD.
次要结局
- Efficacy: Percent Regression(8 weeks)
- Efficacy: Treatment(8 weeks)
- Incidence of AEs(up to 30 days post-treatment)
- Post-procedure pain(24 hours and 7 days post-procedure)