Pilot Feasibility Study: Laser Marking Using the NvisionVLE® Imaging System - VLE laser marking

inepoint Medical0 个研究点目标入组 17 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•Inclusion criteria
•* Patients over the age of 18
•* Patients undergoing an upper endoscopy for Barrett surveillance with prior confirmed BE, with or without neoplasia.
•* Ability to provide written, informed consent.
•* Women of childbearing potential must be willing to take a pregnancy test.;Exclusion criteria
•* Presence of an esophageal mass that precludes full distention of the balloon from the NvisionVLE Optical Probe.
•* Patients with esophageal strictures that would prevent adequate expansion of the balloon from the NvisionVLE Optical Probe.
•* Patients with known inflammatory disease, esophageal tears or ulcers, which would prohibit full distention of the balloon from the NvisionVLE Optical Probe.
•* Patients who are pregnant.
•* Patients with a history of hemostasis disorders*.
•* Hemostasis disorders will include, but will not be limited to: patients with hemophilia or other congenitally acquired clotting factor deficiencies, patients with cirrhosis with coagulopathy, patients known to have thrombocytopenia (<100,000 plt/ul) and individuals with von Willibrand*s disease or other known platelet malfunction disorders.

•Exclusion criteria
•* Presence of an esophageal mass that precludes full distention of the balloon from the NvisionVLE Optical Probe.
•* Patients with esophageal strictures that would prevent adequate expansion of the balloon from the NvisionVLE Optical Probe.
•* Patients with known inflammatory disease, esophageal tears or ulcers, which would prohibit full distention of the balloon from the NvisionVLE Optical Probe.
•* Patients who are pregnant.
•* Patients with a history of hemostasis disorders*.
•* Hemostasis disorders will include, but will not be limited to: patients with hemophilia or other congenitally acquired clotting factor deficiencies, patients with cirrhosis with coagulopathy, patients known to have thrombocytopenia (<100,000 plt/ul) and individuals with von Willibrand*s disease or other known platelet malfunction disorders.

发起方

inepoint Medical