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

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ClinicalTrials.gov Identifier: NCT01322737
Recruitment Status : Completed
First Posted : March 25, 2011
Last Update Posted : December 16, 2014
Sponsor:
Collaborator:
Apollo Endosurgery, Inc.
Information provided by (Responsible Party):
Jeffrey Marks, MD, University Hospitals Cleveland Medical Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colon Disease Gastric Disease Procedure: Tissue Access and Resection System Not Applicable

Detailed Description:

The subject will already be scheduled for segmental colectomy or gastrectomy.

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Evaluation of a Novel Endoscopic Polypectomy Device in Excised Human Colon and Gastric Tissue.
Study Start Date : January 2011
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011
Arms and Interventions
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Arm Intervention/treatment
Experimental: SUMO Tissue Access and Resection System Procedure: 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 Name: SUMO Tissue Access and Resection System


Outcome Measures
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Primary Outcome Measures :
  1. Evidence of the ability of the SUMO device to create a submucosal pocket and resect the overlying mucosa in human colon or stomach. [ Time Frame: (day one)The colon or stomach tissue is evaluated in the Operating Room immediatley following excision. Subjects are not followed after using the excised tissue in the operating room. ]
    Assess the feasibility of the SuMO device for creation of a submucosal pocket and resecting the overlying mucosa in a segment of excised human colon or stomach.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01322737


Locations
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United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Apollo Endosurgery, Inc.
Investigators
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Principal Investigator: Jeffrey Marks, MD University Hospitals Cleveland Medical Center
More Information
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Responsible Party: Jeffrey Marks, MD, Director, Surgical Endoscopy, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT01322737    
Other Study ID Numbers: 06-10-21
First Posted: March 25, 2011    Key Record Dates
Last Update Posted: December 16, 2014
Last Verified: December 2014
Keywords provided by Jeffrey Marks, MD, University Hospitals Cleveland Medical Center:
resection
open
laparoscopic
benign
 malignant
disease
colon
gastric
Additional relevant MeSH terms:
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Colonic Diseases
Stomach Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases