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Completed

NCT Number: NCT02445014

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

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).

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Key information

Conditions

Healthy Barrett Esophagus Barrett's Esophagus Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastric Acid Reflux Gastroesophageal Reflux Gastrointestinal Diseases Neoplasms Precancerous Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

36 subjects including 12 healthy volunteers, 12 patients with Barrett's Esophagus and 12 with Gastroesophageal reflux disease will be enrolled and asked to swallow the SECM HITEC Capsule. The subjects will be awake and unsedated.

The capsule is attached to a string like 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 through the esophagus, multiple images of the esophagus are acquired in real time to be analyzed later.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects must be 1) a healthy volunteer (18 years or older), or 2) a subject with prior diagnosis of BE (18 years or older), or 3) a subject with prior diagnosis of GERD (18 years or older).
  • AND Subject must be able to give informed consent.
  • AND Subject must eat no solid foods for 8 hours before the procedure and only clear liquids for 2 hours before the procedure.

Exclusion criteria

  • Subjects with any history of or known upper gastrointestinal strictures
  • OR Subjects with a history of Crohn's disease,
  • OR Subjects with difficulty swallow

Treatment and study plan

MGH SECM Imaging Capsule

Device

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

Primary outcomes

  1. Feasibility for Imaging of Esophagus Using an SECM Tethered Endoscopic Capsule.

    Time frame: 20 minute visit (5-7 minute imaging)

    The number of subjects from whom successful SECM imaging was obtained

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Official study title

Pilot Study for Imaging of Barrett's Esophagus Using an Spectrally Encoded Confocal Microscopy Tethered Endoscopic Capsule

Acronym: SECM

Important dates

Study start
2014
Primary completion
2017
Study completion
2020
First posted
May 15, 2015
Registry last updated
Aug 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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