Efficacy and safety of a new EMR device for early neoplasia in the Barrett's esophagus. - PreCap-studie

Academisch Medisch Centrum0 个研究点目标入组 11 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

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•1. Age 18-80 years
•2. Subject is scheduled for esophagectomy
•3. Subject is willing to participate, fully understands the content of the informed consent form, and signs the informed consent form.;Phase II
•1. Age 18-80 years
•2. Barrett esophagus with a visible abnormality and biopsy-proven high grade dysplasia and/or early cancer
•3. Lesion with a maximum size of 4 cm in longitudinal length and 50% of the circumference.
•4. No suspicion of submucosal invasion, based on the macroscopic appearance and/or endosonography
•5. No signs of lymph node and/or distant metastasis on endosonography and CT-scanning of the thorax and abdomen.
•6. Patient is scheduled for endoscopic resection of present BE neoplasia
•7. Subject is willing to participate, fully understands the content of the informed consent form, and signs the informed consent form.

•1. Subject has previously undergone endoscopic therapy in the intended treatment zone, including (but not limited to) cryospray therapy, laser treatment, photodynamic therapy, endoscopic mucosal resection, radiofrequency ablation or argon plasma coagulation.
•2. Presence of esophageal stenosis limiting access to the intended treatment zone.
•3. Scarring by other causes of the intended treatment zone.
•4. Subject refuses or is not able to provide written informed consent.;Phase II
•1. Subject has previously undergone endoscopic therapy in the intended treatment zone, including (but not limited to) cryospray therapy, laser treatment, photodynamic therapy, endoscopic mucosal resection, radiofrequency ablation or argon plasma coagulation.
•2. Presence of esophageal stenosis limiting access to the intended treatment zone.
•3. Scarring by any cause of the intended treatment zone.
•4. Subject refuses or is not able to provide written informed consent.

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