NL-OMON43223已完成不适用
CLINICAL TRIAL TO EVALUATE SAFETY AND DOSE RESPONSE USING THE C2 CRYOBALLOON SWIPE ABLATION SYSTEM FOR THE TREATMENT OF BARRETT*S ESOPHAGUS - Swipe dose response study
C2Therapeutics, Marcia Wachna0 个研究点目标入组 18 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Patients with flat-type (Paris type 0-IIb) BE esophagus, with an indication for ablation therapy, meaning:
- •* Diagnosis of Low-grade dysplasia (LGD) or high-grade dysplasia (HGD) in BE (confirmed by baseline histopathological analysis), OR
- •* Residual BE with any grade of dysplasia after endoscopic resection (by means of EMR or ESD) to treat non-flat BE, *6 weeks prior to enrolling the patient to this study. The ER pathology should indicate endoscopic treatment (i.e. only mucosal invasion, no lymphovascular infiltration, free vertical resection margins and not poorly differentiated)
- •2. Prague Classification Score C*3
- •3. Patients should be ablative-naïve, meaning they did not undergo any previous ablation therapy of the esophagus
- •4. Older than 18 years of age at time of consent
- •5. Operable per institution*s standards
- •6. Provides written informed consent on the IRB-approved informed consent form
- •7. Willing and able to comply with follow-up requirements
排除标准
- •1. Esophageal stenosis or stricture preventing advancement of a therapeutic endoscope.
- •2. 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.
- •3. Prior ER >2cm in length and >50% of the esophageal lumen circumference
- •4. History of esophageal cancer (>T1a)
- •5. History of esophageal varices
- •6. Prior distal esophagectomy
- •7. Active esophagitis LA grade B or higher
- •8. Severe medical comorbidities precluding endoscopy
- •9. Uncontrolled coagulopathy
- •10. Pregnant or planning to become pregnant during period of study
- •11. Patient refuses or is unable to provide written informed consent
- •12. Participation in another study with investigational drug or device within the 30 days preceding or during the present study, interfering with participation in this trial
- •13. General poor health, multiple co-morbidities placing the patient at risk or otherwise unsuitable for trial participation
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