NL-OMON49629已完成2 期
First in-human study on the Safety, Tolerability and Efficacy of the Aqua Medical focal vapor ablation system, for the eradication of Barrett*s Esophagus - The STEAM-BE study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
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
- •a. Subject is between 22 * 85 years of age.
- •b. Subject should have Barrett esophagus, with either:
- •I. Barrett esophagus, circumferential extent * 2 cm or tongues * 3 cm,
- •with an indication for ablation therapy, either:
- •i. Flat low grade dysplasia (LGD)
- •ii. Flat high grade dysplasia (HGD)
- •iii. Residual Barrett after removal of visible lesions, containing any
- •grade of dysplasia, or early adenocarcinoma
- •amendable for endoscopic treatment (mucosal or superficial
- •submucosal disease, with well to moderately
- •differentiation and without lymphovascular invasion).
- •II. Barrett esophagus with a visible lesion with a type 0-IIa, -IIb or -IIc
- •component, requiring endoscopic resection
- •c. Hiatal Hernia < 10cm
- •d. Subject has signed the informed consent form and is able to adhere to study
- •visit schedule.
排除标准
- •a. Subject has any condition that in the opinion of the PI preclude enrollment
- •into the trial.
- •b. Subject has had a prior RF or cryoablation procedure
- •c. Subject has predictors for poor regression after ablation therapy, i.e. one
- •of the following:
- •* In case of prior ER: regeneration of the ER scar with Barrett*s mucosa, OR
- •* Active reflux esophagitis grade C or D
- •* Esophageal narrowing pre-treatment with an estimated diameter <20mm
- •* Absence of squamous islands in the BE
- •d. Subject has any significant multisystem diseases.
- •e. Subject has a body mass index (BMI) greater than 40 kg/m2.
- •f. Subject has a hiatal hernia > 10cm
- •g. Subject has known moderate/severe gastroparesis
- •h. Subject is currently enrolled in other potentially confounding research.
- •i. Subject has an esophageal stenosis preventing the passage of an endoscope
研究者
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