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NCT01032044 · ClinicalTrials.gov registry record · NA
CLE for Assessment of Neoplasia After Mucosal Ablation or Resection of Gastrointestinal Neoplasia
A NA study, sponsored by Mauna Kea Technologies.
- Completed
- Registry status
- NA
- Development phase
- 164
- Enrollment target
NCT01032044: Completed NA study, sponsored by Mauna Kea Technologies.
NCT01032044 is a NA study that has completed, run by Mauna Kea Technologies. The registered enrollment target is 164 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01032044, a NA study, has completed, sponsored by Mauna Kea Technologies.
- COMPLETED
- Registry status
- NA
- Development phase
- 164 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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.
Interventions
- DEVICE Standard endoscopic evaluation
- DEVICE pCLE guided evaluation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 164 participants |
| Start Date | 2010-02 |
| Est. Completion | 2011-04 |
| Phase | NA |
What the finished NCT01032044 record still lists
NCT01032044 is an interventional study that assigns participants to a tested intervention. The registered 164 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard endoscopic evaluation is the first listed.
NCT01032044 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01032044 about?
NCT01032044 is a clinical study titled "CLE for Assessment of Neoplasia After Mucosal Ablation or Resection of Gastrointestinal Neoplasia". 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 undergoin...
What is the current status of trial NCT01032044?
This trial is currently completed. It is a NA study. The enrollment target is 164 participants. The study started on 2010-02. Estimated completion is 2011-04.
What interventions are being tested in trial NCT01032044?
The interventions under investigation include: Standard endoscopic evaluation (DEVICE), pCLE guided evaluation (DEVICE).
Who is sponsoring clinical trial NCT01032044?
This trial is sponsored by Mauna Kea Technologies, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01032044's enrollment target sits among peer trials
164 626th of 2000 higher than 1,374 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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