An interventional study of Standard endoscopic evaluation and pCLE guided evaluation in Barrett Syndrome, Barrett's Syndrome and Barrett's Esophagus, sponsored by Mauna Kea Technologies. Completed at 6 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-22.
Sponsored by Mauna Kea Technologies · Not applicable, Interventional, and Diagnostic
This study focuses on demonstrating the value of probe-based Confocal Laser Endomicroscopy (pCLE) in guiding endoscopic therapeutic procedures in Barrett's Esophagus (BE).
It is a randomized controlled outcomes study including patients already treated for Barrett's Esophagus lesion(s) and undergoing high definition white light endoscopy follow up procedure, with or without pCLE (2 arms will be considered in this study). The procedures will be carried out per standards of practice with appropriately trained physicians.
It is a randomized controlled outcomes study including patients already treated for Barrett's Esophagus lesion(s) and undergoing high definition white light endoscopy follow up procedure, with or without pCLE guided evaluation (2 arms will be considered in this study). The procedures will be carried out per standards of practice with appropriately trained physicians.
2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.
This study's enrollment of 164 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:
Standard high-definition white light endoscopy guided evaluation
Device: Standard endoscopic evaluation
Endoscopic evaluation of BE guided by probe-based Confocal Laser Endomicroscopy (pCLE guided evaluation)
Device: pCLE guided evaluation
Treatment modalities can include endoscopic mucosal resection, radio-frequency ablation or photodynamic therapy
Treatment modalities include endoscopic mucosal resection, radio-frequency ablation, or photodynamic therapy. probe-based Confocal Laser Endomicroscopy is used to decide on re-treatment or not, and to guide and evaluate the treatment during the same endoscopic procedure.
Number of Barrett's Esophagus (BE) Participants With a Composite Outcome of "Optimally Treated"
Number of Barrett's Esophagus (BE) Participants with a Composite Outcome of "Optimally Treated", in each group defined as patients for whom all lesions are ablated when disease is present, or not ablated when disease is absent, or have complete ablation of all disease at the 3 month follow-up.
Time frame: 3 month follow-up endoscopic procedure
| Milestone | Standard Treatment | pCLE-guided Treatment |
|---|---|---|
| Started | 82 | 82 |
| Procedure | 74 | 75 |
| Completed | 57 | 62 |
| Not completed | 25 | 20 |
| Withdrew: Protocol violation | 14 | 8 |
| Withdrew: Adverse event | 0 | 1 |
| Withdrew: Lost to follow-up | 11 | 11 |
Number of Barrett's Esophagus (BE) Participants with a Composite Outcome of "Optimally Treated", in each group defined as patients for whom all lesions are ablated when disease is present, or not ablated when disease is absent, or have complete ablation of all disease at the 3 month follow-up.
| participants | Standard Endoscopic Evaluation | pCLE-guided Evaluation |
|---|---|---|
| Number of Barrett's Esophagus (BE) Participants With a Composite Outcome of "Optimally Treated" | 16 | 16 |
Collected over from inclusion to 3 months follow-up visit post-procedure. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard Treatment | — | 0/82 (0%) | 0/82 (0%) |
| pCLE-guided Treatment | — | 1/82 (1.2%) | 0/82 (0%) |
| Event | Standard Treatment | pCLE-guided Treatment |
|---|---|---|
| Intolerance to FluoresceinImmune system disorders | 0/82 | 1/82 |
Exploratory analysis of the data according to the intent-to-treat principle resulted in no suggestion of systematic bias in the two groups regarding withdrawals. Only 1 patient was withdrawn because of intolerance to fluorescein.
| Age, Continuous(years) | Standard Endoscopic Evaluation | pCLE-guided Evaluation | Total |
|---|---|---|---|
| Mean | 67.9 (45.4 to 87.2) | 69.6 (50.2 to 86.1) | 68.8 (45.4 to 87.2) |
| Sex: Female, Male(Participants) | Standard Endoscopic Evaluation | pCLE-guided Evaluation | Total |
|---|---|---|---|
| Female | 4 | 7 | 11 |
| Male | 78 | 75 | 153 |
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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