Nitrous Oxide For Endoscopic Ablation of Refractory Barrett's Esophagus (NO FEAR-BE)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 试验地点
- 11
- 主要终点
- Incidence of CryoBalloon-related serious adverse events
研究概览
简要总结
A multicenter, prospective, single arm, non randomized clinical trial to evaluate the safety and efficacy of the C2 CryoBalloon Focal Ablation System (CbFAS) for the treatment of persistent dysplasia or intestinal metaplasia (IM) in the tubular esophagus after 3 or more radiofrequency ablations (RFA) for dysplastic BE, or <50% eradication of Barrett's Esophagus (BE) after 2 RFA treatments.
详细描述
Eligibility will be determined based on historical local pathology and medical record information. Informed consent will be obtained and eligible subjects will be treated with the Cryoballoon Focal Ablation System (CbFAS) at baseline.
Subjects will return every 3 months +/- 6 weeks for repeat treatment for up to 12 months OR until complete eradication of intestinal metaplasia (CEIM) and complete eradication of dysplasia (CED) are achieved (at which point subjects enter the follow-up phase), whichever occurs first.
Treatment procedures will be performed on an outpatient basis according to the site's standards of care for anesthesia and sedation during esophagogastroduodenoscopy (EGD) procedures. EGD examinations will be performed using high definition White Light Endoscopy (WLE), plus Narrow Band Imaging (NBI) or i-SCAN to assess BE measurements and identify tissue landmarks and ablation zones.
A high definition endoscope will be used for all ablations performed with the CryoBalloon Focal Ablation System (CbFAS). The System will be used according to the instructions for use provided with the product and in accordance with the current standard of care for treatment of BE.
Repeat cryoablation may be performed if esophageal columnar mucosa is visible on EGD or if intervening biopsies (if a site chooses to obtain intervening biopsies as standard of care) are positive for any esophageal columnar epithelium until complete eradication of all unwanted tissue is achieved.
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
- •History of BE with LGD or HGD confirmed with biopsy, or resected intramucosal cancer (IMC) with low risk of recurrence defined as EMR/ESD pathology results negative for: positive margin, >T1a stage, poorly differentiated carcinoma, and lymphovascular invasion.
- •Prior treatment with RFA who meet either of the following criteria at the enrolling EGD:
- •History of at least 3 RFA treatments, with one or more of the following:
- •Residual BE Prague >=C1
- •Residual BE >=M1
- •One or more islands of residual BE >=1 cm in diameter
- •Any residual dysplasia in tubular esophagus 2.
- •History of at least 2 RFA treatments and < 50% eradication of BE, as judged by estimation of the treating physician.
- •18 or older years of age at time of consent.
- •Provides written informed consent.
- •Willing to undergo an alternative approved standard of care treatment for their condition.
- •Willing and able to comply with study requirements for follow-up.
- •No prior history of balloon or spray cryotherapy esophageal treatment. Prior APC is allowable.
排除标准
- •Residual BE Prague length measuring >C3 or >M8 after RFA treatment.
- •Dysplasia or IM confined only to the gastric cardia.
- •Pre-existing esophageal stenosis/stricture preventing advancement of a therapeutic endoscope during screening/baseline EGD. Subjects are eligible if the stenosis/stricture is dilated to at least 15mm, but baseline treatment may need to be delayed per protocol.
- •Symptomatic, untreated esophageal strictures.
- •5. Any endoscopically visualized abnormalities such as ulcers, masses, or nodules found in the BE during screening/baseline EGD. Subjects with nodular dysplasia or IMC identified during screening/baseline EGD may be treated with EMR or ESD and return for baseline treatment in this study at least 6 weeks later given that: 5.
- •Follow-up endoscopy must be negative for nodular dysplasia (visually clear of nodular dysplasia).
- •Patients with IMC must be at low risk for recurrence, confirmed by EMR/ESD pathology results negative for: positive margin, >T1a stage, poorly differentiated carcinoma, and lymphovascular invasion.
- •EMR or ESD < 6 weeks prior to baseline treatment.
- •Untreated invasive esophageal malignancy, including margin-positive EMR/ESD.
- •Active reflux esophagitis grade B or higher in the BE assessed during screening/baseline EGD.
- •Severe medical comorbidities precluding endoscopy or limiting life expectancy to less than 2 years in the judgment of the endoscopist.
- •Uncontrolled coagulopathy.
- •Inability to hold use of anti-coagulation medications or non-aspirin anti-platelet agents (APAs) for the duration recommended per ASGE guidelines for a high-risk endoscopy procedure.
- •Active fungal esophagitis.
- •Known portal hypertension, visible esophageal varices, or history of esophageal varices.
- •General poor health, multiple co-morbidities placing the patient at risk, or otherwise unsuitable for trial participation.
- •Pregnant or planning to become pregnant during period of study participation.
- •Patient refuses or is unable to provide written informed consent.
- •Prior esophageal surgery with the exception of uncomplicated nissen fundoplication.
研究组 & 干预措施
Cryoballoon Focal Ablation System (CbFAS) Treatment
Subjects undergoing CbFAS treatment as part of their clinical care for their condition.
干预措施: CryoBalloon Focal Ablation System (Device)
结局指标
主要结局
Incidence of CryoBalloon-related serious adverse events
时间窗: 12 months
Relation of serious adverse events to CryoBalloon device will be assessed by the PI
Percentage of all treated Subjects with complete eradication of all intestinal metaplasia (CEIM) within 12 months of enrollment.
时间窗: 12 months
Percentage of all treated subjects with complete eradication of dysplasia (CED) within 12 months of enrollment
时间窗: 12 months
Stratified by prior type of ablation treatment and baseline grade (LGD or HGD) will also be reported.
次要结局
- Technical success rate(At end of treatment period, up to 12 months)
- Survival curve analysis - time to CEIM(At end of treatment period, up to 12 months)
- Mean number of CryoBalloon ablation treatments required to achieve CED and CEIM by 12 months from enrollment date.(At end of treatment period, up to 12 months)
- Progression rate(At end of treatment period, up to 12 months)
- Median number of CryoBalloon ablation treatments required to achieve CED and CEIM by 12 months from enrollment date.(At end of treatment period, up to 12 months)
- Proportion of subjects requiring narcotic analgesic - Day 7(Day 7)
- Median pain score - Day 1(Day 1)
- Procedure success rate(At end of treatment period, up to 12 months)
- Survival curve analysis - time to recurrence(At end of treatment period, up to 12 months)
- Proportion of subjects requiring narcotic analgesic - Day 1(Day 1)
- Proportion of subjects requiring narcotic analgesic - Day 30(Day 30)
- Mean pain score - Day 1(Day 1)
- Survival curve analysis - time to progression(At end of treatment period, up to 12 months)
- Median pain score - Day 30(Day 30)
- Risk factors associated with failure to respond to CryoBalloon ablation(At end of treatment period, up to 12 months)
- Median pain score - Day 7(Day 7)
- Mean pain score - Day 30(Day 30)
- Proportion of Barrett's Esophagus surface area reverted to neosquamous epithelium(At end of treatment period, up to 12 months)
- Mean pain score - Day 7(Day 7)