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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01322737
• Date of registration: 07/03/2011
• Primary sponsor: University Hospitals of Cleveland
• Public title: Feasibility Trial to Evaluate the Ability of the SuMO Tissue Access and Resection System SUMO
• Scientific title: Evaluation of a Novel Endoscopic Polypectomy Device in Excised Human Colon and Gastric Tissue.
• Date of first enrolment: January 2011
• Target sample size: 9
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01322737
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Open Label

Countries of recruitment

United States

Contacts

• Name: Jeffrey Marks, MD
• Affiliation: UHCMC

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Colon Disease

Gastric Disease

Intervention(s)

Procedure: Tissue Access and Resection System

Primary Outcome(s)

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.]

Secondary ID(s)

06-10-21

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Apollo Endosurgery, Inc.