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

NCT01322737 | Completed

• 1 other identifier: 06-10-21
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Disease; Gastric Disease

Keywords

resection; open; laparoscopic; benign; malignant; disease; colon; gastric

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

SUMO Tissue Access and Resection System

EXPERIMENTAL

Procedure: Tissue Access and Resection System

Interventions

Tissue Access and Resection System PROCEDURE

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

Also known as: SUMO Tissue Access and Resection System

SUMO Tissue Access and Resection System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Apollo Endosurgery, Inc.: collaborator

Study Sites (1)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Colonic Diseases; Stomach Diseases; Disease

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeffrey Marks, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Surgical Endoscopy

Study Record Dates

• First Submitted: March 7, 2011
• First Posted: March 25, 2011
• Study Start: January 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: December 16, 2014

Record last verified: 2014-12

Locations

US (1)