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| Name | Class |
|---|---|
| Cellvizio Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard endoscopic evaluation | Active Comparator | Standard high-definition white light endoscopy guided evaluation |
|
| pCLE-guided evaluation | Experimental | Endoscopic evaluation of BE guided by probe-based Confocal Laser Endomicroscopy (pCLE guided evaluation) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard endoscopic evaluation | Device | Treatment modalities can include endoscopic mucosal resection, radio-frequency ablation or photodynamic therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 month follow-up endoscopic procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Wallace, MD | Mayo Clinic Jacksonville, Florida, United States | Principal Investigator |
| Anne Osdoit | Mauna Kea Technologies, Paris, France | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Jacksonville | Florida | 32224 | United States | ||
| University of Chicago Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22749368 | Derived | Wallace MB, Crook JE, Saunders M, Lovat L, Coron E, Waxman I, Sharma P, Hwang JH, Banks M, DePreville M, Galmiche JP, Konda V, Diehl NN, Wolfsen HC. Multicenter, randomized, controlled trial of confocal laser endomicroscopy assessment of residual metaplasia after mucosal ablation or resection of GI neoplasia in Barrett's esophagus. Gastrointest Endosc. 2012 Sep;76(3):539-47.e1. doi: 10.1016/j.gie.2012.05.004. Epub 2012 Jun 28. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Treatment | Standard high-definition white light endoscopy guided treatment Standard endoscopic treatment of BE: Treatment modalities can include endoscopic mucosal resection, radio-frequency ablation or photodynamic therapy |
| FG001 | pCLE-guided Treatment |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| pCLE guided evaluation | Device | 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. |
|
| Chicago |
| Illinois |
| 60637 |
| United States |
| Veterans Affairs Hospital | Kansas City | Missouri | 64128 | United States |
| University of Washington Medical Center | Seattle | Washington | 98115 | United States |
| Centre Hospitalier Universitaire | Nantes | France |
| University College London Hospital | London | United Kingdom |
Endoscopic treatment of BE guided by probe-based Confocal Laser Endomicroscopy 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. |
| Procedure |
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| COMPLETED |
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| NOT COMPLETED |
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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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Endoscopic Evaluation | Standard high-definition white light endoscopy guided evaluation Standard endoscopic evaluation: Treatment modalities can include endoscopic mucosal resection, radio-frequency ablation or photodynamic therapy |
| BG001 | pCLE-guided Evaluation | Endoscopic evaluation of BE guided by probe-based Confocal Laser Endomicroscopy (pCLE guided evaluation) 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Among the 141 patients who completed the initial procedure, 119 had follow-up visits. | Posted | Number | participants | 3 month follow-up endoscopic procedure |
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from inclusion to 3 months follow-up visit post-procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Treatment | Standard high-definition white light endoscopy guided treatment Standard endoscopic treatment of BE: Treatment modalities can include endoscopic mucosal resection, radio-frequency ablation or photodynamic therapy | 0 | 82 | 0 | 82 | ||
| EG001 | pCLE-guided Treatment | Endoscopic treatment of BE guided by probe-based Confocal Laser Endomicroscopy 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. | 1 | 82 | 0 | 82 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intolerance to Fluorescein | Immune system disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Michael B. Wallace | Mayo Clinic, Jacksonville, Florida, USA | 904 953-7630 | wallace.michael@mayo.edu |
| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| Male |
|