Feasibility Trial to Evaluate the Ability of the SuMO Tissue Access and Resection System
NCT ID: NCT01322737
Last Updated: 2014-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
9 participants
INTERVENTIONAL
2011-01-31
2011-06-30
Brief Summary
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Detailed Description
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The colectomy or gastrectomy specimen will be prepared on a side table for an ex vivo endoscopic procedure. The ends of the stomach or colon, if not already stapled closed will be ligated to allow for insufflation. The endoscope will be placed into the excised organ and the SuMO System devices will be deployed away from any areas of excised pathologic tissue, so as not to disrupt the pathologist's evaluation of the excised tissue. The specimen will then be opened and grossly examined for the actual completeness of the submucosal pocket and resection. Mucosal and muscular wall disruptions will be assessed. Again, no interference in the underlying pathology will be performed. If sufficient specimen is present, the SuMO procedure may be repeated on the same specimen.
Following the performance of the EMR by the SUMO balloon system on the ex vivo colon specimen, both the resected piece of tissue and the site of resection will be evaluated pathologically by H and E staining. Specifically, the depth of resection in the ex vivo colon specimen will be determined. In addition, the level of dissection on the removed piece of mucosa will also be identified.
During this procedure still images or a video recording maybe captured, however all images will be taken of the removed specimen. There will not be any patient identifiers on any of the images or DVD's taken during the procedure.
No clinical follow up is required, as the treated area will have already been resected and there is no risk to the patient.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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SUMO Tissue Access and Resection System
Tissue Access and Resection System
This feasibility trial will assess the effectiveness of SuMO System to create a submucosal pocket and resect the overlying mucosa in excised human colonic or gastric tissue
Interventions
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Tissue Access and Resection System
This feasibility trial will assess the effectiveness of SuMO System to create a submucosal pocket and resect the overlying mucosa in excised human colonic or gastric tissue
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Subjects who would have difficulty comprehending or complying with the requirements of the study
* Subjects who fail to give informed consent
18 Years
ALL
Yes
Sponsors
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Apollo Endosurgery, Inc.
INDUSTRY
University Hospitals Cleveland Medical Center
OTHER
Responsible Party
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Jeffrey Marks, MD
Director, Surgical Endoscopy
Principal Investigators
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Jeffrey Marks, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center
Locations
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University Hospitals Case Medical Center
Cleveland, Ohio, United States
Countries
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Other Identifiers
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06-10-21
Identifier Type: -
Identifier Source: org_study_id