Post-sleeve Gastrectomy Gastroesophageal Reflux Disease Prediction
NCT ID: NCT04411823
Last Updated: 2025-02-18
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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RECRUITING
NA
200 participants
INTERVENTIONAL
2021-02-01
2028-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Intervention arm
Undergo an upper endoscopy with EndoFLIP at baseline before sleeve gastrectomy
EndoFLIP measurement
EndoFLIP device can measure gastroesophageal junction distensibility index and esophageal contractile pattern under FDA cleared indication. It is performed during endoscopy.
Interventions
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EndoFLIP measurement
EndoFLIP device can measure gastroesophageal junction distensibility index and esophageal contractile pattern under FDA cleared indication. It is performed during endoscopy.
Eligibility Criteria
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Inclusion Criteria
* BMI 30 or greater kg/m2
* Participants can give a consent to the procedure
* Participants have no contraindications to LSG (gastric ulceration)
Exclusion Criteria
* Patients who have evidence of a major motility abnormality defined by the Chicago classification version 3.0 (achalasia, absent contractility, esophagogastric junction outflow obstruction, distal esophageal spasm, or hypertensive peristalsis)
* Patients with hiatal hernia \> 3 cm
* Patients with previous esophageal or stomach surgery
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Omar Ghanem
Principal Investigator
Principal Investigators
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Omar Ghanem, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Orlando Health
Orlando, Florida, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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19-000348
Identifier Type: -
Identifier Source: org_study_id
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