Trials / Completed
CompletedNCT01032044
CLE for Assessment of Neoplasia After Mucosal Ablation or Resection of Gastrointestinal Neoplasia
Confocal Laser Endomicroscopy for Assessment of Neoplasia After Mucosal Ablation or Resection of Gastrointestinal Neoplasia
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 164 (actual)
- Sponsor
- Mauna Kea Technologies · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Standard endoscopic evaluation | Treatment modalities can include endoscopic mucosal resection, radio-frequency ablation or photodynamic therapy |
| DEVICE | pCLE guided evaluation | 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. |
Timeline
- Start date
- 2010-02-01
- Primary completion
- 2011-04-01
- Completion
- 2011-04-01
- First posted
- 2009-12-15
- Last updated
- 2016-04-22
- Results posted
- 2016-04-22
Locations
6 sites across 3 countries: United States, France, United Kingdom
Source: ClinicalTrials.gov record NCT01032044. Inclusion in this directory is not an endorsement.