Clinical trial · Interventional
Pilot Study to Image the Esophagus Using a SECM Tethered Endoscopic Capsule
Pilot Study for Imaging of Barrett's Esophagus Using an Spectrally Encoded Confocal Microscopy Tethered Endoscopic Capsule
NCT02445014CI-TRIAL-00046758SECMcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett's Esophagus | — | UNRESOLVED | — |
| Gastric Acid Reflux | — | UNRESOLVED | — |
| Healthy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MGH SECM Imaging Capsule | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MGH SECM Imaging Capsule
- description
- Subject will swallow the SECM imaging capsule and images will be acquired using the SECM Imaging system.
- interventionNames
- Device: MGH SECM Imaging Capsule
Primary outcomes (1)
- measure
- Feasibility for Imaging of Esophagus Using an SECM Tethered Endoscopic Capsule.
- timeFrame
- 20 minute visit (5-7 minute imaging)
- description
- The number of subjects from whom successful SECM imaging was obtained
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.