NCT01439633

Brief Summary

The specific aim of this study is to determine the feasibility of marking target pathologic locations identified on Optical Frequency Domain Imaging (OFDI) datasets using superficial cautery marks of the esophagus that are visible by endoscopy for subsequent guidance of biopsy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2010

Longer than P75 for not_applicable

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

October 1, 2010

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 23, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

September 25, 2018

Completed
Last Updated

April 10, 2019

Status Verified

April 1, 2019

Enrollment Period

3.6 years

First QC Date

September 20, 2011

Results QC Date

July 24, 2018

Last Update Submit

April 1, 2019

Conditions

Barrett's Esophagus

Keywords

Barrett's EsophagusEsophagusOCTImaging

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects in Which the Targeted Locations Identified Through OFDI Imaging Correlates With the Biopsies.

    Determination of the feasibility to mark targeted pathologic locations identified through OFDI imaging using superficial cautery marks.Verification by endoscopy and utilization of the marks for biopsy guidance.Images will be analyzed and compared to biopsies of the correlated marked tissue.

    day 1, during diagnostic procedure

Study Arms (1)

MGH OFDI marking and imaging

EXPERIMENTAL

OFDI imaging

Device: MGH OFDI marking

Interventions

MGH OFDI markingDEVICE

Imaging of esophagus with OFDI system

MGH OFDI marking and imaging

Eligibility Criteria

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

You may qualify if:

  • Patients undergoing an EGD for Barrett's esophagus surveillance with a prior confirmed Barrett's segment at least 1 cm in length
  • Patients must be over the age of 18
  • Patient must be able to give informed consent
  • Women with child bearing potential must have a negative pregnancy test prior to procedure

You may not qualify if:

  • Patients on anti-platelet and anti-coagulation medications and NSAIDS at the time of procedure
  • Patients with a history of hemostasis disorders
  • Patients that are pregnant
  • Patients with esophageal strictures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • Suter MJ, Gora MJ, Lauwers GY, Arnason T, Sauk J, Gallagher KA, Kava L, Tan KM, Soomro AR, Gallagher TP, Gardecki JA, Bouma BE, Rosenberg M, Nishioka NS, Tearney GJ. Esophageal-guided biopsy with volumetric laser endomicroscopy and laser cautery marking: a pilot clinical study. Gastrointest Endosc. 2014 Jun;79(6):886-96. doi: 10.1016/j.gie.2013.11.016. Epub 2014 Jan 23.

    PMID: 24462171DERIVED

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Results Point of Contact

Title
Gary Tearney, PI
Organization
Massachusetts General Hospital
gtearney@partners.org
617-724-2979

Study Officials

  • Guillermo Tearney, MD PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

  • Norman Nishioka, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pathology

Study Record Dates

First Submitted

September 20, 2011

First Posted

September 23, 2011

Study Start

October 1, 2010

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

April 10, 2019

Results First Posted

September 25, 2018

Record last verified: 2019-04

Locations

US(1)