Prospective Evaluation of the Efficacy and Safety of Submucosal Endoscopy
NCT ID: NCT03626350
Last Updated: 2024-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
250 participants
OBSERVATIONAL
2018-06-12
2025-06-12
Brief Summary
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The aim of the proposed study is to prospectively assess technical success, clinical success, and adverse events after submucosal endoscopy. Technical success will be defined as ability to successfully complete the submucosal endoscopic procedure. Clinical success will be defined as symptom relief and objective evaluation which will be assessed with radiologic imaging, repeat endoscopy, gastrointestinal motility studies, and pathology results routinely performed post-procedure for clinical care, as indicated. Adverse events will be recorded per published ASGE criteria.
A database/ registry of patients undergoing submucosal endoscopic procedures will be created to demonstrate this.
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. Age \>18 years
Exclusion Criteria
2. Pregnancy
3. Coagulopathy (platelets less than 50, INR more than 1.8)
18 Years
89 Years
ALL
No
Sponsors
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University of Colorado, Denver
OTHER
Responsible Party
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Locations
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University of Colorado Hospital
Aurora, Colorado, United States
Countries
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Other Identifiers
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18-0046
Identifier Type: -
Identifier Source: org_study_id
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