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Improving Complete Endoscopic Mucosal Resection (EMR) of Colorectal Neoplasia

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ClinicalTrials.gov Identifier: NCT01471756
Recruitment Status : Completed
First Posted : November 16, 2011
Last Update Posted : September 8, 2014
Sponsor:
Collaborator:
US Endoscopy
Information provided by (Responsible Party):
Timothy Woodward, Mayo Clinic

Brief Summary:
The investigators seek to compare two techniques of removing pre-cancerous lesions from the colon. The investigators also will compare two solutions used during the procedure to determine if either solution allows for an improved removal of the tumors.

Condition or disease Intervention/treatment Phase
Neoplasms Gastric Cancer Procedure: Standard of Care Procedure as described in ARM Phase 4

Detailed Description:
The primary aim of the study is to compare the efficacy, efficiency and safety of two types of snares used in Endoscopic Mucosal Resection (EMR), a combined needle and snare unit (ISnare, US Endoscopy) versus an oval braided snare with spiral wire (Snaremaster, Olympus). The secondary aim is to explore whether EMR efficacy and efficiency is depended upon the injection solution used, saline versus Gonak (a solution containing HPMC, saline, and epinephrine) for EMR.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Complete Endoscopic Mucosal Resection (EMR) of Colorectal Neoplasia: A Randomized Prospective Comparison of Snares and Injectate in the Resection of Large Sessile Colonic Polyps
Study Start Date : October 2011
Actual Primary Completion Date : July 2013
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: iSnare with Gonak solution Procedure: Standard of Care Procedure as described in ARM
Standard of Care Procedure as described in ARM
Experimental: Snaremaster braided snare with Gonak solution Procedure: Standard of Care Procedure as described in ARM
Standard of Care Procedure as described in ARM
Experimental: iSnare with saline solution Procedure: Standard of Care Procedure as described in ARM
Standard of Care Procedure as described in ARM
Experimental: Snaremaster braided snare with saline solution Procedure: Standard of Care Procedure as described in ARM
Standard of Care Procedure as described in ARM



Primary Outcome Measures :
  1. Efficacy of Two Devices used in EMR [ Time Frame: 1 year ]
    To explore the efficacy of two devices used in EMR (iSnare® system versus Snaremaster) as measured by the "Sydney Resection Quotient" (SRQ). SRQ is defined as "lesion size in mm divided by the number of pieces to resect" .


Secondary Outcome Measures :
  1. Compare the Use of Two Injectates [ Time Frame: 1 year ]
    To compare the use of two injectates (saline versus HPMC mixture) with respect to efficacy as measured by the aforementioned SRQ.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Sessile colorectal polyp
  • laterally spreading lesions as defined by Paris Classification type II and > 1 cm or greater

Exclusion Criteria:

  • Those with ulcerated depressed lesions (Paris type III) or biopsy proven invasive carcinoma
  • Inflammatory bowel disease patients
  • Coagulopathy ( INR> 1.5) that cannot be corrected

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01471756


Locations
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
US Endoscopy
Investigators
Principal Investigator: Timothy A Woodward, M.D. Mayo Clinic

Responsible Party: Timothy Woodward, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01471756     History of Changes
Other Study ID Numbers: 10-008104
First Posted: November 16, 2011    Key Record Dates
Last Update Posted: September 8, 2014
Last Verified: September 2014

Keywords provided by Timothy Woodward, Mayo Clinic:
sessile neoplasms
flat neoplasms
gastric cancer

Additional relevant MeSH terms:
Neoplasms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases