EndoFLIP Measurement for Sleeve Gastrectomy GERD Prediction
Trial Summary
What is the purpose of this trial?
Researchers are trying to identify predictors for gastroesophageal reflux disease after sleeve gastrectomy.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment EndoFLIP measurement for predicting GERD after sleeve gastrectomy?
Research suggests that the EndoFLIP device, which measures the shape and flexibility of the gastroesophageal junction (where the stomach meets the esophagus), can improve surgical outcomes in procedures like fundoplication for GERD. This implies it might help predict GERD after sleeve gastrectomy by providing real-time measurements during surgery.12345
Is EndoFLIP safe for use in humans?
How does the EndoFLIP treatment for GERD differ from other treatments?
EndoFLIP is unique because it uses a special probe to measure the flexibility and size of the esophagus in real-time during surgery, which can help predict and improve outcomes for GERD (gastroesophageal reflux disease) treatment. This approach is different from traditional methods that do not provide such detailed, immediate feedback during the procedure.12567
Research Team
Omar Ghanem, MD
Principal Investigator
Mayo Clinic
Eligibility Criteria
This trial is for adults over 18 with a BMI of 30 or more who can consent to the procedure and have no gastric ulcers. It's not for those with severe esophagitis, Barrett's esophagus, peptic strictures, major swallowing muscle problems, large hiatal hernias (>3 cm), or past stomach surgeries.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Pre-operative Assessment
Subjects undergo an upper endoscopy with EndoFLIP before sleeve gastrectomy to measure parameters for prediction model development
Post-operative Follow-up
Subjects may undergo a repeat upper endoscopy with EndoFLIP at 6 months if clinically indicated and complete questionnaires during follow-ups
Long-term Follow-up
Participants complete questionnaires to monitor for gastroesophageal reflux disease and dysphagia up to 5 years
Treatment Details
Interventions
- EndoFLIP measurement
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor