An interventional study of Imaging procedures (NBI) and HDWLE in Barrett Syndrome, Barrett's Syndrome and Barrett's Esophagus, sponsored by Mauna Kea Technologies. Completed at 5 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-03.
Sponsored by Mauna Kea Technologies · Not applicable, Interventional, and Diagnostic
This study will collect data from patients routinely undergoing a endoscopic surveillance and Cellvizio endomicroscopy procedure due to confirmed Barrett's esophagus. The objective is to determine if endomicroscopy images collected using the marketed Cellvizio device may help endoscopists more accurately diagnose, in conjunction with traditional tissue sampling techniques, whether a suspected lesion is malignant or benign.
This is a longitudinal observational study were imaging procedures are allocated in a random order to directly address the low sensitivity and specificity of enhanced macroscopic endoscopic imaging devices by determining whether probe-based Confocal Laser Endomicroscopy (pCLE), as a supplement to Narrow Band Imaging (NBI) can further improve sensitivity and specificity to a level that would be acceptable to avoid random biopsy, and better direct biopsy of suspicious areas. The study is also addressing pCLE as a supplement to standard white light endoscopy and random biopsy alone. In fact, the study is powered to evaluate per lesion sensitivity and specificity of confocal imaging as applied to lesions identified by white light endoscopy. Therefore, the study addresses the shortcomings of standard white light endoscopy (high number of random biopsies, less than ideal directed biopsy of suspicious areas) and the primary shortcomings of Narrow Band Imaging (NBI) (low specificity with resultant high false positives, again resulting in many unnecessary biopsies).
2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.
This study's enrollment of 122 is above the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →Mauna Kea Technologies is the lead sponsor of 12 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All patients undergo both endoscopic imaging procedures and then the endomicroscopy procedure; the endoscopic imaging procedures being performed back to back by two endoscopists, blinded to each other.
Device: Imaging procedures (NBI) · Device: HDWLE · Device: pCLE
All patients undergo both endoscopic imaging procedures and then the endomicroscopy procedure; the endoscopic imaging procedures being performed back to back by two endoscopists, blinded to each other.
Device: Imaging procedures (NBI) · Device: HDWLE · Device: pCLE
Imaging procedures (pCLE) and (NBI) - All patients undergo both procedures back to back by two endoscopists, blinded to each other, in randomized order. Procedure 1: Standard endoscopic procedure The patient receives white light endoscopy (WLE) examination. All visible lesions are noted and photographed. No biopsy is taken until both procedures are complete. Procedure 2: NBI endoscopic procedure The patient receives a NBI endoscopy examination. All visible and NBI abnormal lesions are noted and photographed. After both procedures are complete and all sites are unblinded to both endoscopists. pCLE with Cellvizio and physical biopsies are performed at all sites plus 4 quadrant sites.
Also known as: Cellvizio
Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using pCLE Associated With WLE, or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett's Esophagus.
Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using Probe-based Confocal Laser Endomicroscopy (pCLE) Associated With White Light Endoscopy (WLE), or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett's Esophagus.
Time frame: Centralized histopathology confirmation within 4-6 weeks
| Milestone | HDWLE First NBI Second and pCLE | NBI First HDWLE Second and pCLE |
|---|---|---|
| Started | 65 | 57 |
| Completed | 57 | 44 |
| Not completed | 8 | 13 |
| Withdrew: Tissue sampling incomplete/conclusive | 8 | 13 |
Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using Probe-based Confocal Laser Endomicroscopy (pCLE) Associated With White Light Endoscopy (WLE), or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett's Esophagus.
| percentage of lesions | HDWLE | NBI (Narrow Band Imaging) | pCLE | HDWLE+NBI+pCLE | HDWLE+pCLE | HDWLE+NBI |
|---|---|---|---|---|---|---|
| Sensitivity | 34.2 (25.7 to 42.7) | 41.7 (32.8 to 50.5) | 62.5 (53.8 to 71.2) | 75.8 (68.2 to 83.5) | 68.3 (60.0 to 76.7) | 45.0 (36.1 to 53.9) |
| Specificity | 92.7 (90.8 to 94.6) | 90.5 (88.4 to 92.5) | 92.7 (90.8 to 94.6) | 84.2 (81.6 to 86.8) | 87.8 (85.5 to 90.1) | 88.2 (85.9 to 90.5) |
Collected over Acutely during the procedure - within the day. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1 | — | 0/122 (0%) | 0/122 (0%) |
| Age, Continuous(years) | Group 1 |
|---|---|
| Mean | 65.1 ± 11.52 |
| Sex: Female, Male(Participants) | Group 1 |
|---|---|
| Female | 14 |
| Male | 87 |
| Region of Enrollment(participants) | Group 1 |
|---|---|
| France | 9 |
| United States | 62 |
| Germany | 30 |
Plan to share: No
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Mauna Kea Technologies