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

Colon Disease Clinical Trial

— SUMO  

Official title:

Evaluation of a Novel Endoscopic Polypectomy Device in Excised Human Colon and Gastric Tissue.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01322737
• Other study ID #: 06-10-21
• Status: Completed
• Phase: N/A
• First received: March 7, 2011
• Last updated: December 12, 2014
• Start date: January 2011
• Est. completion date: June 2011

Study information

• Verified date: December 2014
• Source: University Hospital Case Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Colon Disease
• Colonic Diseases
• Gastric Disease
• Stomach Diseases

Intervention

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

Locations

Country	Name	City	State
United States	University Hospitals Case Medical Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Case Medical Center	Apollo Endosurgery, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of the ability of the SUMO device to create a submucosal pocket and resect the overlying mucosa in human colon or stomach.	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.	(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.	No