Actively Recruiting
Prediction of Post-laparoscopic Sleeve Gastrectomy Gastroesophageal Reflux Disease Using EndoFLIP Device
Led by Mayo Clinic · Updated on 2026-03-05
200
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how to predict gastroesophageal reflux disease (GERD) that may develop after sleeve gastrectomy, a type of weight-loss surgery. This study focuses on assessing parameters from an endoscopy and a device called EndoFLIP to help identify risk factors for GERD following the surgery. The research is sponsored by Mayo Clinic and involves adult patients undergoing bariatric surgery. Participants will have an upper endoscopy combined with EndoFLIP measurements before their sleeve gastrectomy to collect key data about the gastroesophageal junction and esophageal function. If clinically needed, a repeat endoscopy with EndoFLIP may be performed six months after surgery. Follow-up includes completing questionnaires for up to five years to monitor any changes. During the study, participants will undergo these procedures and assessments at baseline, with possible repeat testing at six months, and ongoing follow-up visits up to five years. The main outcome measured is the development or worsening of GERD symptoms after surgery. Researchers will use the collected data to develop models predicting GERD risk. This long-term monitoring aims to improve understanding and management of complications after sleeve gastrectomy.
CONDITIONS
Brief Title
Post-sleeve Gastrectomy Gastroesophageal Reflux Disease Prediction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients older than 18 years
- Body mass index (BMI) of 30 or greater kg/m2
- Ability to give consent to the procedure
- No contraindications to laparoscopic sleeve gastrectomy such as gastric ulceration
You will not qualify if you...
- Presence of LA grade C or D esophagitis, Barrett mucosa, or peptic stricture
- Evidence of major esophageal motility disorders (achalasia, absent contractility, esophagogastric junction outflow obstruction, distal esophageal spasm, or hypertensive peristalsis)
- Hiatal hernia larger than 3 cm
- History of previous esophageal or stomach surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Baseline
Participants undergo an upper endoscopy with the EndoFLIP device before sleeve gastrectomy to measure parameters for predicting gastroesophageal reflux disease.
1 visit (in-person)
Duration - Single day procedure
Participants undergo laparoscopic sleeve gastrectomy as part of their clinical care.
Duration - 6 months after surgery
If clinically indicated, participants undergo a repeat upper endoscopy with EndoFLIP at 6 months after surgery.
1 visit (in-person)
Duration - Up to 5 years
Participants complete questionnaires during follow-ups to monitor for gastroesophageal reflux disease up to 5 years after surgery.
Trial Site Locations
Total: 2 locations
1
Orlando Health
Orlando, Florida, United States, 32806
Active, Not Recruiting
2
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
E
Elizabeth Lemke
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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