Clinical Trial To Evaluate Safety and Efficacy of the C2 CyroBalloon™ 180 Ablation System for the Treatment of Dysplastic Barrett's Esophagus: CBAS180 De-escalation Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 62
- 试验地点
- 6
- 主要终点
- Safety: Incidence of Dose-related SAEs
研究概览
简要总结
The primary objective is to determine the safety and efficacy of the C2 CryoBalloon 180 Ablation System ("CryoBalloon 180") used at decreasing doses in ablation naïve patients with low- or high-grade dysplastic Barrett's Esophagus (BE) or with residual BE after resection of dysplasia or early adenocarcinoma.
详细描述
The procedure will be performed on an outpatient basis, and the CryoBalloon 180 Ablation system 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 62 patients will be treated with Dose 1 (lowest), in one application to ablate 50% of the esophageal circumference.
All patients will undergo 10 week (±2 weeks) follow-up EGD to evaluate efficacy of the dose before the study continues.
If follow-up shows that Dose 1 eradicates ≤60% of the treated BE (by median percentage) and no SAE's are reported, the treatment phase will continue but at the next incremental higher dose (Second Dose) after approval from the IRB.
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 BE esophagus, with an indication for ablation therapy, defined as:
- •Diagnosis of LGD or HGD in BE (confirmed by central pathology review), OR
- •Residual BE with any grade of dysplasia 6 weeks after endoscopic resection
- •Prague Classification Score C≤3 and ≥M1
- •Patients should be ablation-naïve (no previous ablation therapy of the esophagus)
- •Older than 18 years of age at time of consent
- •Operable per institution's standards
- •Patient provides written informed consent on the IRB-approved informed consent form
- •Patient is willing and able to comply with follow-up requirements.
排除标准
- •Esophageal stenosis preventing advancement of a therapeutic endoscope
- •Any endoscopically visualized lesion such as ulcers, masses or nodules. Neoplastic nodules must first be treated with ER ≥6 weeks prior to planned treatment under this protocol.
- •Prior ER of more than 2cm in length and/or >50% of the esophageal lumen circumference
- •History of locally advanced (>SM1) 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, interfering with participation in the current study
- •General poor health, multiple co-morbidities placing the patient at risk or otherwise unsuitable for trial participation
研究组 & 干预措施
C2 CryoBalloon 180 Ablation System
C2 CryoBalloon 180 Ablation System will be used to ablate visible Barrett's esophagus
干预措施: C2 CryoBalloon 180° Ablation System (Device)
结局指标
主要结局
Safety: Incidence of 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.
Efficacy: Dose response
时间窗: 10 weeks
Dose response (efficacy) is defined as eradication percentage of BE confirmed by histological evidence of eradication of BE, after treatment with the therapeutic dose.
次要结局
- Incidence of AEs(30 days)
- Efficacy: Treatment(10 weeks)
- Patient reported post-procedure pain(24hours and 7 days post-procedure)
- Efficacy: Percent Regression(10 weeks)