Feasibility Trial to Evaluate the Ability of the SuMO Tissue Access and Resection System

Completed · Not applicable

Conditions studied: Colon Disease, Gastric Disease

In brief

This feasibility trial will evaluate the ability of the SuMO Tissue Access and Resection System (Apollo Endosurgery, Austin, Texas). The SuMO System utilizes balloons to create a submucosal pocket and electrosurgical cutting device to resect the mucosa. The SuMO elevates the tissue from the underlying muscularis using a balloon to distend the submucosa, similar to what is currently performed with injectable saline in a standard EMR. After dissection of the lesion, a separate cutting device will be utilized to resect the tissue by cutting around the border of the targeted tissue. If needed, a standard loop snare will be used to complete the mucosal resection.

Key facts

Study ID

NCT01322737

Run by

University Hospitals Cleveland Medical Center

People needed

9

Starts

2011-01-01

Expected to finish

2011-06-01

Last updated by the study team

2014-12-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female over 18 years of age
• Established indication for open or laparoscopic or colon resection or gastrectomy
• Subject agrees to participate, fully understands content of informed consent form, and signs the informed consent form

You may not qualify if…

• Subjects that are minors or prisoners
• Subjects who would have difficulty comprehending or complying with the requirements of the study
• Subjects who fail to give informed consent

Where it is running

• University Hospitals Case Medical Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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