Optical Frequency Domain Imaging (OFDI) Surveillance and Image Guided Biopsy of the Esophagus
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|ClinicalTrials.gov Identifier: NCT01439633|
Recruitment Status : Completed
First Posted : September 23, 2011
Results First Posted : September 25, 2018
Last Update Posted : April 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Barrett's Esophagus||Device: MGH OFDI marking||Not Applicable|
Twenty four consenting patients undergoing esophagogastroduodenoscopy (EGD) surveillance following a confirmed diagnosis of Barrett's esophagus will be recruited at Massachusetts General Hospital (MGH) . Along with Optical Frequency Domain Imaging (OFDI) imaging and cautery marking for targeted biopsy, the patients will undergo a standard of care clinical Esophagogastroduodenoscopy (EGD) procedure including endoscopic random biopsy. This study requires the use of a balloon catheter which is a commonly used technique and is accepted in clinical practice for dilation of esophageal and colonic strictures and for photodynamic therapy.
Once in position, the OFDI tissue marking laser will be activated by the physician. The physician will control the marking and make two marks of a duration of 2 seconds each. The 2 seconds time period will limit the tissue effects to only the superficial layers of the esophageal mucosa.
It is expected that the total experimental time including insertion and inflation of the OFDI balloon catheter, OFDI imaging, tissue marking, and removal of the OFDI balloon will add approximately 15 minutes to the total length of the EGD.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study to Evaluate OFDI Surveillance and Image Guided Biopsy of the Esophagus|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
Experimental: MGH OFDI marking and imaging
Device: MGH OFDI marking
Imaging of esophagus with OFDI system
- Number of Subjects in Which the Targeted Locations Identified Through OFDI Imaging Correlates With the Biopsies. [ Time Frame: day 1, during diagnostic procedure ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01439633
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Guillermo Tearney, MD PhD||Massachusetts General Hospital|
|Principal Investigator:||Norman Nishioka, MD||Massachusetts General Hospital|