Study Results
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View full resultsBasic Information
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TERMINATED
NA
3 participants
INTERVENTIONAL
2017-03-22
2017-06-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Endoscopic submucosal resection with Extracelluar Matrix
Subjects with lesions that lift and are amenable to cap-assisted endoscopic submucosal resection (EMR) will receive extracellular matrix (ECM) to the defect site.
Acell MatriStem® Surgical Matrix
Extracellular matrix (ECM) product that is composed of collagen and natural proteins that provide a re-absorbable scaffold for tissue remodeling to facilitate constructive healing following endoscopic submucosal resection (EMR). Covers the defect site following mucosal resection using endoscopy clips or X-tac. The device will remain attached to the esophagus and integrate with native tissue over time.
Endoscopic submucosal resection standard of care
Subjects with lesions that lift and are amenable to cap-assisted endoscopic submucosal resection (EMR) will receive standard of care.
No interventions assigned to this group
Interventions
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Acell MatriStem® Surgical Matrix
Extracellular matrix (ECM) product that is composed of collagen and natural proteins that provide a re-absorbable scaffold for tissue remodeling to facilitate constructive healing following endoscopic submucosal resection (EMR). Covers the defect site following mucosal resection using endoscopy clips or X-tac. The device will remain attached to the esophagus and integrate with native tissue over time.
Eligibility Criteria
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Inclusion Criteria
* Scheduled for standard of care endoscopy that may require initial EMR evaluation of esophageal lesions
* Histological evidence of intestinal metaplasia with dysplasia or intramucosal carcinoma
Exclusion Criteria
* Prior esophageal EMR or ESD in the same region
* Anyone unable to provide informed consent
* Medical co-morbidities precluding EGD evaluation
* History of chemoradiotherapy to the neck/esophagus
* Unable to stop anticoagulation therapy (non-steroid anti-inflammatory medications are permissible)
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Kenneth K. Wang
Pricipal Investigator
Principal Investigators
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Kenneth K Wang
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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16-006909
Identifier Type: -
Identifier Source: org_study_id
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