Feasibility and efficacy of CryoBalloon Focal Ablation System on dysplastic esophageal squamous cell tissue: a proof of principle - Cryoablation for dysplastic esophageal squamous epithelium

Academisch Medisch Centrum0 个研究点目标入组 3 人开始时间: 待定最近更新: 2024年2月28日

试验速览

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•- Patients with at least one unstained lesion (USL) *1.5cm2 in the esophagus upon high resolution endoscopy (HRE) with Lugol*s staining
•- Completely flat (type 0-IIb) lesions inside the USL or, in case of a prior type 0-IIa/IIc lesion, endoscopic resection of these lesions *8 weeks before cryoablation
•- Proven medium-grade or high-grade intraepithelial neoplasia (MGIN or HGIN) in at least one USL
•- In case of prior endoscopic resection: endoscopic resection specimens must have demonstrated *T1m3, negative deep resection margins, good or moderate tumor differentiation, no signs of lymphovascular invasion
•- Age between 18 and 85
•- Signed informed consent

•- Esophageal stenosis preventing advancement of a therapeutic endoscope and/or within 4 cm of treatment zone.
•- Patient with a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post treatment instructions or follow-up guidelines.
•- Patient refuses or is unable to provide written informed consent.
•- Patients that are pregnant.
•- Patient with endoscopically active inflammation in the treatment zone.

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