Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Apollo Endosurgery, Inc.
Information provided by (Responsible Party):
Jeffrey Marks, MD, University Hospital Case Medical Center Identifier:
First received: March 7, 2011
Last updated: December 12, 2014
Last verified: December 2014
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 Intervention
Colon Disease
Gastric Disease
Procedure: Tissue Access and Resection System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Evaluation of a Novel Endoscopic Polypectomy Device in Excised Human Colon and Gastric Tissue.

Further study details as provided by University Hospitals Cleveland Medical Center:

Primary Outcome Measures:
  • 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.

Enrollment: 9
Study Start Date: January 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01322737

United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Apollo Endosurgery, Inc.
Principal Investigator: Jeffrey Marks, MD UHCMC
  More Information

Responsible Party: Jeffrey Marks, MD, Director, Surgical Endoscopy, University Hospital Case Medical Center Identifier: NCT01322737     History of Changes
Other Study ID Numbers: 06-10-21
Study First Received: March 7, 2011
Last Updated: December 12, 2014

Keywords provided by University Hospitals Cleveland Medical Center:

Additional relevant MeSH terms:
Colonic Diseases
Stomach Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases processed this record on April 26, 2017