Prospective Evaluation of Performance of Disposable Elevator Cap Duodenoscope During ERCP in Clinical Practice
NCT ID: NCT04447976
Last Updated: 2021-01-12
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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UNKNOWN
100 participants
OBSERVATIONAL
2020-06-02
2022-07-31
Brief Summary
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Research design: This is a prospective observational multi-center study. Procedure used: During ERCP
Risks and potential benefits: There are no risks associated with this study as it is a retrospective chart review. Potential benefits include the knowledge gained from this study which may be of help to patients in the future.
Importance of knowledge that may reasonably be expected to result: The quality of health care which will be crucial to identify patterns of competence and identify areas of continued improvement. More specifically in the quality metrics sector we will be able to see what is already in place and steps we will undertake that will be beneficial for physicians.
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Detailed Description
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This is a multi-center study being performed at the University of Texas Health Science Center, Wake Forest Baptist Health and Institute of Gastroenterology in Ecuador. The study will enroll a total of 100 patients who undergo ERCP. The study is purely observational as it will collect clinical success and information of the TIP duodenoscope.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Patients undergoing ERCP by formally trained Endoscopists
No intervention has been used and this is an observational study of evaluation of a TIP duodenoscope performance overall.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Patient has a clinical indication for ERCP.
Exclusion Criteria
* Patients who refuse to consent for ERCP procedure.
18 Years
100 Years
ALL
Yes
Sponsors
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Wake Forest University Health Sciences
OTHER
Instituto Ecuatoriano de Enfermedades Digestivas
OTHER
The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Nirav C Thosani
Associate Professor
Principal Investigators
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Nirav Thosani, MD, MHA
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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Memorial Hermann Hospital
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HSC-MS-20-0408
Identifier Type: -
Identifier Source: org_study_id
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