NCT04411823

Post-sleeve Gastrectomy Gastroesophageal Reflux Disease Prediction

Prediction of Post-laparoscopic Sleeve Gastrectomy Gastroesophageal Reflux Disease With an Endolumenal Functional Lumen Imaging Probe (EndoFLIP)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Subjects will undergo an upper endoscopy with EndoFLIP before sleeve gastrectomy to measure parameters from endoscopy and EndoFLIP device to develop a prediction model for post-operative gastroesophageal reflux disease. Subjects will undergo a repeat upper endoscopy with EndoFLIP at 6 months if an upper endoscopy is clinically indicated after surgery and complete questionnaires during follow-ups up to 5 years.

Conditions

• Gastroesophageal Reflux
• Sleeve Gastrectomy
• Bariatric Surgery Complication

Interventions

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

Timeline

• Start date: 2021-02-01
• Primary completion: 2028-10-01
• Completion: 2028-10-01
• First posted: 2020-06-02
• Last updated: 2026-03-05

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study