Using Spectrally Encoded Confocal Microscopy (SECM) to Image the Esophagus
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|ClinicalTrials.gov Identifier: NCT02202590|
Recruitment Status : Active, not recruiting
First Posted : July 29, 2014
Last Update Posted : August 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Eosinophilic Esophagitis||Device: SECM Capsule||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||84 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study to Image the Esophagus Using Spectrally Encoded Confocal Microscopy (SECM)|
|Actual Study Start Date :||October 2013|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2022|
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
- SECM Imaging quality. Assessed qualitative values like resolution, tissue architecture, background scatter etc. [ Time Frame: A single 20 minute visit (5-7 minute imaging). ]An investigator will qualitatively assess the the Feasibility of SECM Capsule and Imaging in EoE participant versus Healthy Controls. He 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.
- Tolerability of SECM Capsule Imaging Procedure in Healthy and EoE Participant, measured by feedback scores. [ Time Frame: Questionnaire adminstered directly after the imaging portion has been completed. ]After participating in the study, the subject will be asked for feedback about tolerability of the procedure using a questionnaire. This entails questions about discomfort levels and the participants ability to tolerate the tether and capsule during the whole and parts of the procedures. using a 0 -10 scale, participants will score how comfortable the procedure was during each stage. 10 being the most discomfort and 0 being the least discomfort.
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): NCT02202590
|United States, Massachusetts|
|Massachusetts General hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Guillermo Tearney, MD., PhD||Massachusetts General Hospital|