N/A
N=6
Using Spectrally Encoded Confocal Microscopy (SECM) to Visualise the Esophagus Using an SECM Probe
Barrett's Esophagus
Bottom Line
View on ClinicalTrials.gov: NCT02210039 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcome: Primary: Number of Participants With Tolerability of the Procedure — 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SECM Probe (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Tolerability of the Procedure |
6 | — |
Summary
The study is being done to test the feasibility and tolerability of a SECM imaging probe in patients with Barrett's Esophagus (BE).
Subjects will undergo SECM probe imaging while they are under conscious sedation. Spiral SECM imaging will be performed continuously over a pre-determined length. Patients will later be asked for their feedback.
Eligibility Criteria
Inclusion Criteria
- A previous diagnosis of Barrett's Esophagus
- Patients must be over the age of 18
- Patient must be able to give informed consent
Exclusion Criteria
- Subjects with any history of intestinal strictures
- OR subjects with a history of prior GI surgery
- OR subjects with a history of intestinal Crohn's disease.
Data sourced from ClinicalTrials.gov (NCT02210039). 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.