Confocal Laser Endomicroscopy for Assessment of Neoplasia After Mucosal Ablation or Resection of Gastrointestinal Neoplasia (CLEAN-MARGIN)
This study has been completed.
Sponsor:
Mauna Kea Technologies
Collaborator:
Cellvizio Inc.
Information provided by (Responsible Party):
Mauna Kea Technologies
ClinicalTrials.gov Identifier:
NCT01032044
First received: December 11, 2009
Last updated: June 4, 2012
Last verified: June 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Barrett Syndrome Barrett's Syndrome Barrett's Esophagus Barrett Esophagus Adenocarcinoma |
Device: Standard endoscopic treatment of BE Device: pCLE guided endoscopic treatment of BE |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Diagnostic |
Resource links provided by NLM:
Further study details as provided by Mauna Kea Technologies:
Primary Outcome Measures:
- Composite outcome of "optimally treated" BE patients 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 ] [ Designated as safety issue: No ]
| Enrollment: | 166 |
| Study Start Date: | February 2010 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Standard treatment
Standard high-definition white light endoscopy guided treatment
|
Device: Standard endoscopic treatment of BE
Treatment modalities can include endoscopic mucosal resection, radio-frequency ablation or photodynamic therapy
|
|
Experimental: pCLE-guided treatment
Endoscopic treatment of BE guided by probe-based Confocal Laser Endomicroscopy
|
Device: pCLE guided endoscopic treatment of BE
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with BE with Intestinal Metaplasia, Low Grade-IntraEpithelial Neoplasia/High Grade-IntraEpithelial Neoplasia as the original indication for ablative treatment.
- Undergoing any type of endoscopic BE ablation treatment
- <2cm of circumferential BE and <5 total islands of BE on prior to last ablation.
- Age > 18 years
- Ability to provide written, informed consent
Exclusion Criteria:
- Participation in another clinical study
- Circumferential BE
- Complete eradication of BE documented by biopsies
- Inability to obtain biopsies due to anticoagulation, varices, etc.
- Allergy to fluorescein
- Pregnancy
- Renal insufficiency
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01032044
Locations
| United States, Florida | |
| Mayo Clinic | |
| Jacksonville, Florida, United States | |
| United States, Illinois | |
| University of Chicago Hospital | |
| Chicago, Illinois, United States | |
| United States, Missouri | |
| Veterans Affairs Hospital | |
| Kansas City, Missouri, United States | |
| United States, Washington | |
| University of Washington Medical Center | |
| Seattle, Washington, United States | |
| France | |
| Centre Hospitalier Universitaire | |
| Nantes, France | |
| United Kingdom | |
| University College London Hospital | |
| London, United Kingdom | |
Sponsors and Collaborators
Mauna Kea Technologies
Cellvizio Inc.
Investigators
| Principal Investigator: | Michael Wallace, MD | Mayo Clinic Jacksonville, Florida, United States |
| Study Director: | Anne Osdoit | Mauna Kea Technologies, Paris, France |
More Information
No publications provided by Mauna Kea Technologies
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Mauna Kea Technologies |
| ClinicalTrials.gov Identifier: | NCT01032044 History of Changes |
| Other Study ID Numbers: | MKT-2009-BE-01 |
| Study First Received: | December 11, 2009 |
| Last Updated: | June 4, 2012 |
| Health Authority: | United States: Institutional Review Board France: Comité de Protection des Personnes United Kingdom: Research Ethics Committee |
Keywords provided by Mauna Kea Technologies:
|
Barrett's esophagus EsoGastroDuodenoscopy Barrett's carcinoma adenocarcinoma Cellvizio endomicroscopy |
probe-based Confocal Laser Endomicroscopy pCLE Radio-frequency ablation Endoscopic mucosal resection Photodynamic therapy |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Barrett Esophagus Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Neoplasms, Cystic, Mucinous, and Serous Digestive System Abnormalities Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases |
ClinicalTrials.gov processed this record on May 22, 2013