NCT00855790

Brief Summary

The purpose of this study is to evaluate the efficacy of the new RJ4 compare with the standard RJ3 biopsy forceps for performing polypectomy for small colorectal polyps.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2008

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

Study Start

First participant enrolled

December 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 4, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

July 23, 2015

Status Verified

July 1, 2015

Enrollment Period

11 months

First QC Date

March 2, 2009

Last Update Submit

July 22, 2015

Conditions

Colorectal Polyps

Keywords

evaluate the effectiveness of one bite polypectomy with the RJ3 biopsy forcep versus the RJ4 biopsy forcep

Outcome Measures

Primary Outcomes (1)

  • Complete endoscopic (visual) eradication of the polyp with the first forceps bite

    one year

Secondary Outcomes (3)

  • Number of bites to completely visually eradicate the polyp if the polyp was not fully eradicated with the first forceps bite

    one year

  • Complete pathologic eradication of the polyp on the first forceps bite.

    one year

  • Correlate endoscopic with pathologic eradication

    one year

Study Arms (2)

RJ3 Biopsy Forcep

ACTIVE COMPARATOR

use of RJ3 Biopsy forcep for the polypectomy

Other: evaluate the effectiveness of the RJ4 biopsy forcep versus the RJ3 biopsy forcep

RJ4 Biopsey Forcep

ACTIVE COMPARATOR

Use of RJ$ biopsy forcep for polypectomy

Other: evaluate the effectiveness of the RJ4 biopsy forcep versus the RJ3 biopsy forcep

Interventions

evaluate the effectiveness of the RJ4 biopsy forcep versus the RJ3 biopsy forcepOTHER

Use of either the RJ3 or RJ4 biopsy forcep for colon polypectomy. will evaluate the effectiveness of removal of polyps less than 6 mm.

RJ3 Biopsy ForcepRJ4 Biopsey Forcep

Eligibility Criteria

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

You may qualify if:

  • colon polyps less than 6 mm

You may not qualify if:

  • no colon polyps

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shands Endocopy Center

Gainesville, Florida, 32610, United States

Location

Related Publications (1)

  • Draganov PV, Chang MN, Alkhasawneh A, Dixon LR, Lieb J, Moshiree B, Polyak S, Sultan S, Collins D, Suman A, Valentine JF, Wagh MS, Habashi SL, Forsmark CE. Randomized, controlled trial of standard, large-capacity versus jumbo biopsy forceps for polypectomy of small, sessile, colorectal polyps. Gastrointest Endosc. 2012 Jan;75(1):118-26. doi: 10.1016/j.gie.2011.08.019.

    PMID: 22196811DERIVED

Study Officials

  • Peter Draganov, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2009

First Posted

March 4, 2009

Study Start

December 1, 2008

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

July 23, 2015

Record last verified: 2015-07

Locations

US(1)