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Improving Complete Endoscopic Mucosal Resection (EMR) of Colorectal Neoplasia

This study is currently recruiting participants.
Verified January 2013 by Mayo Clinic
Sponsor:
Collaborator:
US Endoscopy
Information provided by (Responsible Party):
Timothy Woodward, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01471756
First received: September 29, 2011
Last updated: January 17, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention Phase
Neoplasms
Gastric Cancer
 Procedure: Standard of Care Procedure as described in ARM
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Efficacy of Two Devices used in EMR [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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:
  • Compare the Use of Two Injectates [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To compare the use of two injectates (saline versus HPMC mixture) with respect to efficacy as measured by the aforementioned SRQ.


Estimated Enrollment: 140
Study Start Date: October 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01471756

Contacts
Contact: Joy Hardee 904-953-8456 hardee.darla@mayo.edu

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

No publications provided

Responsible Party: Timothy Woodward, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01471756     History of Changes
Other Study ID Numbers: 10-008104
Study First Received: September 29, 2011
Last Updated: January 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on June 17, 2013