NCT01471756

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2011

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2011

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 16, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

September 8, 2014

Status Verified

September 1, 2014

Enrollment Period

1.8 years

First QC Date

September 29, 2011

Last Update Submit

September 5, 2014

Conditions

NeoplasmsGastric Cancer

Keywords

sessile neoplasmsflat neoplasmsgastric cancer

Outcome Measures

Primary Outcomes (1)

  • Efficacy of Two Devices used in EMR

    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" .

    1 year

Secondary Outcomes (1)

  • Compare the Use of Two Injectates

    1 year

Study Arms (4)

iSnare with Gonak solution

EXPERIMENTAL
Procedure: Standard of Care Procedure as described in ARM

Snaremaster braided snare with Gonak solution

EXPERIMENTAL
Procedure: Standard of Care Procedure as described in ARM

iSnare with saline solution

EXPERIMENTAL
Procedure: Standard of Care Procedure as described in ARM

Snaremaster braided snare with saline solution

EXPERIMENTAL
Procedure: Standard of Care Procedure as described in ARM

Interventions

Standard of Care Procedure as described in ARMPROCEDURE

Standard of Care Procedure as described in ARM

Snaremaster braided snare with Gonak solutionSnaremaster braided snare with saline solutioniSnare with Gonak solutioniSnare with saline solution

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

MeSH Terms

Conditions

NeoplasmsStomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Timothy A Woodward, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 29, 2011

First Posted

November 16, 2011

Study Start

October 1, 2011

Primary Completion

July 1, 2013

Study Completion

May 1, 2014

Last Updated

September 8, 2014

Record last verified: 2014-09

Locations

US(1)