Improving Complete Endoscopic Mucosal Resection (EMR) of Colorectal Neoplasia

NCT ID: NCT01471756

Last Updated: 2014-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Neoplasms Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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iSnare with Gonak solution

Group Type EXPERIMENTAL

Standard of Care Procedure as described in ARM

Intervention Type PROCEDURE

Standard of Care Procedure as described in ARM

Snaremaster braided snare with Gonak solution

Group Type EXPERIMENTAL

Standard of Care Procedure as described in ARM

Intervention Type PROCEDURE

Standard of Care Procedure as described in ARM

iSnare with saline solution

Group Type EXPERIMENTAL

Standard of Care Procedure as described in ARM

Intervention Type PROCEDURE

Standard of Care Procedure as described in ARM

Snaremaster braided snare with saline solution

Group Type EXPERIMENTAL

Standard of Care Procedure as described in ARM

Intervention Type PROCEDURE

Standard of Care Procedure as described in ARM

Interventions

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Standard of Care Procedure as described in ARM

Standard of Care Procedure as described in ARM

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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US Endoscopy

INDUSTRY

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Timothy Woodward

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Timothy A Woodward, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Jacksonville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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10-008104

Identifier Type: -

Identifier Source: org_study_id

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