N/A
N=3
Pilot Study to Image the Esophagus Using a SECM Tethered Endoscopic Capsule
Healthy · Barrett's Esophagus · Gastric Acid Reflux
Bottom Line
View on ClinicalTrials.gov: NCT02445014 ↗Enrolled (actual)
3
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Feasibility for Imaging of Esophagus Using an SECM Tethered Endoscopic Capsule. — 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MGH SECM Imaging Capsule (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility for Imaging of Esophagus Using an SECM Tethered Endoscopic Capsule. |
3 | — |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02445014). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.