Post-sleeve Gastrectomy Gastroesophageal Reflux Disease Prediction

Part of paid clinical trials in Orlando, Florida.

Sponsor
Mayo Clinic
Study ID
NCT04411823
Status
Recruiting
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Conditions

  • Bariatric Surgery Complication
  • Gastroesophageal Reflux
  • Sleeve Gastrectomy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • EndoFLIP measurement — DEVICE
    EndoFLIP device can measure gastroesophageal junction distensibility index and esophageal contractile pattern under FDA cleared indication. It is performed during endoscopy.

Study Details

Researchers are trying to identify predictors for gastroesophageal reflux disease after sleeve gastrectomy.

Key Dates

Start date
Feb 1, 2021
Status verified
Mar 2026
Primary completion
Oct 31, 2028
Completion
Oct 31, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Intervention arm
    Undergo an upper endoscopy with EndoFLIP at baseline before sleeve gastrectomy

Primary Outcome Measure

Worsening or new-onset gastroesophageal reflux disease [ Time Frame: Baseline, 6 months, and 5 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Orlando HealthOrlandoFlorida32806-
Mayo Clinic in RochesterRochesterMinnesota55905
Abi Stromme
[email protected]
507-538-8238
Elizabeth Lemke
[email protected]
507-266-3317
Omar Ghanem, MD (SUB_INVESTIGATOR)

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