Optical Frequency Domain Imaging (OFDI) Assessment in Radiofrequency Ablation

NCT01439594 | Completed Results

• 1 other identifier: 2008-P000793
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this research is to conduct a pilot clinical study to evaluate the potential use of esophageal Optical Frequency Domain Imaging (OFDI) for assessing the success and degree of injury associated with therapeutic radiofrequency ablation techniques.

Conditions

Barrett's Esophagus

Keywords

Barrett's Esophagus; Esophagus; OCT; Imaging; Radiofrequency Ablation; BARRX

Outcome Measures

Primary Outcomes (1)

• Feasibility of OFDI Imaging as Determined by Number of Successful Imaging Sessions

  Images will be taken and compared to standard of care biopsy to assess the success and degree of injury associated with radiofrequency ablation techniques. A successful imaging session is defined as any session where the OFDI device was able to take and produce discernible and clear data that is comparable to corresponding biopsy histopathology. It is considered unsuccessful if we were unable to produce OFDI data and/or attain a corresponding biopsy.

  During the OFDI imaging session (about 5 minutes)

Study Arms (1)

MGH OFDI Imaging

EXPERIMENTAL

OFDI imaging

Device: MGH OFDI Imaging

Interventions

MGH OFDI Imaging DEVICE

Imaging of Esophagus with OFDI system

MGH OFDI Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a diagnosis of Barrett's esophagus
• Patients undergoing an Esophagogastroduodenoscopy (EGD)
• Patients scheduled for treatment with RF ablation or patients that have had previous BARRX RF ablation
• 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 oral anticoagulation medications
• Patients with a history of hemostasis disorders
• Patients that are pregnant
• Patients with esophageal strictures

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: Dr. 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: DEVICE FEASIBILITY
• 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, 2008
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: November 22, 2019
• Results First Posted: November 22, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)