Resection of mucosa of human colon or rectal tissue using a new endoscopic device, the SuMO (Sub Mucosal Operation) Tissue Access and Resection System - Endoscopic mucosal resection in the colon and rectum using SuMO

Academisch Medisch Centrum0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

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•* The patient is between 18 and 80 years of age.
•* The patient is willing to be available for the appropriate follow-up for the duration of the study
•* Written informed consent;Group A:
•* Indication for a partial colon resection via laparoscopy or laparotomy for a benign or malignant lesion.
•* Indication for an endoscopic mucosal resection (EMR) for a benign rectal lesion.
•* Diameter of lesion < 4cm

•* The patient is not between 18 and 80 years of age.
•* The patient is unwilling to be available for the appropriate follow-up for the duration of the study.
•* The patient is mentally incompetent and does not understand the procedure and associated risks.
•* The patient is unable and/or unwilling to cooperate with study procedures or required follow-up visits.
•* The patient has any of the following conditions:
•o Recent myocardial infarction (acute MI)
•o Bleeding disorders/anticoagulation (non-reversible bleeding disorders or coagulopathy)
•o Prior colorectal surgery
•o Pregnant or actively breastfeeding.
•o Any other condition or anatomical limitation that would contraindicate them for laparoscopic surgery, a lower GI endoscopic procedure, or surgical anesthesia.;Group A:
•* ASA class IV or V
•* Patient is suffering from any of the following conditions:
•o Crohn*s Disease;Group B:
•* ASA class IV or V
•* Patient is suffering from any of the following conditions:
•o Crohn*s Disease
•o Severe diverticulitis
•o Previous rectal ESD or EMR

发起方