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NCT01322737 · ClinicalTrials.gov registry record · NA

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

A NA study of Gastric Disease and Colon Disease, sponsored by University Hospitals Cleveland Medical Center.

Completed
Registry status
NA
Development phase
9
Enrollment target
1
Study location

NCT01322737 is a NA study of Gastric Disease and Colon Disease that has completed, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 9 participants. The trial reports 1 study location across 1 state.

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The verdict

NCT01322737, a NA study of Gastric Disease and Colon Disease, has completed, sponsored by University Hospitals Cleveland Medical Center.

COMPLETED
Registry status
NA
Development phase
9 participants
Enrollment target
1
Study location

Study 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.

Interventions

  • PROCEDURE Tissue Access and Resection System

Study Locations (1)

Ohio

  • University Hospitals Case Medical Center - Cleveland

Trial Details

FieldValue
Enrollment Target 9 participants
Start Date 2011-01
Est. Completion 2011-06
Phase NA

What the Registry Record Tells You About NCT01322737

The ClinicalTrials.gov registry entry for NCT01322737 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University Hospitals Cleveland Medical Center, which has 230 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Gastric Disease appearing as the primary indexed condition, and to 1 intervention - of which Tissue Access and Resection System is the first listed.

NCT01322737 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.

Frequently Asked Questions

What is clinical trial NCT01322737 about?

NCT01322737 is a clinical study titled "Feasibility Trial to Evaluate the Ability of the SuMO Tissue Access and Resection System". 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 underlyi...

What is the current status of trial NCT01322737?

This trial is currently completed. It is a NA study. The enrollment target is 9 participants. The study started on 2011-01. Estimated completion is 2011-06.

What conditions does trial NCT01322737 study?

This clinical trial studies the following conditions: Gastric Disease, Colon Disease.

What interventions are being tested in trial NCT01322737?

The interventions under investigation include: Tissue Access and Resection System (PROCEDURE).

Who is sponsoring clinical trial NCT01322737?

This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01322737 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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