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Pilot Study to Image the Esophagus Using a SECM Tethered Endoscopic Capsule

NCT02445014 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2020-08-21

Study results available
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Summary

The goal of this research is to test the imaging quality of the modified, larger diameter, tethered Spectrally Encoded Confocal Microscopy (SECM) capsule in healthy subjects, subjects with Barrett's Esophagus (BE), and subjects with Gastroesophageal reflux disease (GERD).

Conditions

  • Healthy
  • Barrett's Esophagus
  • Gastric Acid Reflux

Interventions

DEVICE

MGH SECM Imaging Capsule

Imaging of the Esophagus using the SECM capsule and SECM Imaging system

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Cancer Institute (NCI)

    collaborator NIH

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Guillermo Tearney, MD., PhD · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2017-01-31
Completion
2020-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02445014 on ClinicalTrials.gov