Using Spectrally Encoded Confocal Microscopy (SECM) to Image the Esophagus
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
|Official Title:||Pilot Study to Image the Esophagus Using Spectrally Encoded Confocal Microscopy (SECM)|
- Measure the tolerability of SECM Capsule and imaging in healthy subjects as well as patients with Eosinophilic Esophagitis. [ Time Frame: Images will be acquired during the SECM imaging session and should take an average of 10 minutes. ]After participating in the study, the subject will be asked for feedback about tolerability of the procedure using a questionnaire.
- Measure the feasibility of SECM Capsule and imaging in healthy subjects as well as patients with Eosinophilic Esophagitis. [ Time Frame: Measure the feasibility of SECM Capsule and imaging in healthy subjects as well as patients with Eosinophilic Esophagitis. ]An investigator will assess the quality of the recorded images and movies obtained with each exam after the imaging is completed. The images obtained by the SECM Capsule will be compared to the images obtained by clinical endoscopy if available.
|Study Start Date:||October 2013|
|Estimated Study Completion Date:||December 2018|
|Estimated Primary Completion Date:||October 2018 (Final data collection date for primary outcome measure)|
Subject will swallow the SECM capsule and Imaging will be performed using the SECM Imaging system.
Device: SECM Capsule
Imaging of the esophagus using the SECM capsule and system
72 subjects including healthy volunteers, patients with a suspicion of having Eosinophilic Esophagitis (EoE) and patients with a clinical diagnosis of EoE will be recruited and asked to swallow the SECM capsule while being awake and unsedated. The capsule is attached to a tether which allows the operator to control as well as navigate the capsule as it progresses down the esophagus using natural propulsive force called peristalsis.
As the capsule progresses, multiple 2-dimensional cross sectional images of the esophagus are acquired. Images are analyzed at a later stage.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02202590
|Contact: Guillermo Tearney, MD., PhDemail@example.com|
|Contact: Catriona Grant, BSN, RNfirstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Guillermo Tearney, MD., PhD||Massachusetts General Hospital|