200 Participants Needed

EndoFLIP Measurement for Sleeve Gastrectomy GERD Prediction

Recruiting at 1 trial location
EH
EL
AT
MJ
Overseen ByMuhammad Jawad, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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?

EndoFLIP has been used safely in various surgeries, such as fundoplication and esophagomyotomy, to measure the esophagus and stomach junction. It has been used internationally for several years without reported safety issues.12346

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

OG

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

Participants can give consent to the procedure
I don't have any stomach ulcers.
BMI 30 or greater kg/m2
See 1 more

Exclusion Criteria

I have severe esophagitis, Barrett's esophagus, or a peptic stricture.
I have had surgery on my esophagus or stomach.
I have a diagnosed esophagus movement disorder.
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Assessment

Subjects undergo an upper endoscopy with EndoFLIP before sleeve gastrectomy to measure parameters for prediction model development

1 week
1 visit (in-person)

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

6 months
1 visit (in-person) if indicated, regular follow-up questionnaires

Long-term Follow-up

Participants complete questionnaires to monitor for gastroesophageal reflux disease and dysphagia up to 5 years

5 years

Treatment Details

Interventions

  • EndoFLIP measurement
Trial Overview The study is using EndoFLIP measurement to find ways to predict acid reflux disease after sleeve gastrectomy surgery. Researchers want to see if this tool can help foresee complications related to bariatric surgery.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Intervention armExperimental Treatment1 Intervention
Undergo an upper endoscopy with EndoFLIP at baseline before sleeve gastrectomy

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Findings from Research

The functional lumen imaging probe (Endoflip) effectively measures esophagogastric junction (EGJ) capacity and diameter in real-time during surgeries for achalasia and gastroesophageal reflux disease (GERD), demonstrating significant changes in compliance before and after surgical interventions.
Using Endoflip during procedures like Heller myotomy and Nissen fundoplication allows surgeons to visualize and assess the EGJ's physiological changes dynamically, potentially improving surgical outcomes and aiding in training for esophageal surgeries.
Video. Improving functional esophageal surgery with a "smart" bougie: Endoflip.Perretta, S., Dallemagne, B., McMahon, B., et al.[2012]
In a study of 97 fundoplication surgeries, using a 40 ml balloon volume significantly improved measurements of the gastroesophageal junction, indicating better distensibility and pressure metrics compared to a 30 ml volume.
The study found that patient positioning (reverse Trendelenburg) and the presence of pneumoperitoneum also affected measurements, suggesting that these factors should be standardized to optimize surgical outcomes during fundoplication.
Using a standardized intra-operative endoflip protocol during fundoplication to identify factors that affect distensibility.Su, B., Attaar, M., Wong, H., et al.[2021]
The use of the EndoFLIP™ probe during laparoscopic fundoplication and hiatal hernia repair provides valuable measurements of esophageal distensibility, which correlate with long-term patient outcomes, particularly regarding symptoms like gas bloat and dysphagia.
Patients with a final distensibility index (DI) between 2.0 and 3.5 mm²/mmHg reported better outcomes, suggesting this range may be optimal for minimizing postoperative complications.
Using impedance planimetry (EndoFLIP™) in the operating room to assess gastroesophageal junction distensibility and predict patient outcomes following fundoplication.Su, B., Novak, S., Callahan, ZM., et al.[2022]

References

Video. Improving functional esophageal surgery with a "smart" bougie: Endoflip. [2012]
Using a standardized intra-operative endoflip protocol during fundoplication to identify factors that affect distensibility. [2021]
Using impedance planimetry (EndoFLIP™) in the operating room to assess gastroesophageal junction distensibility and predict patient outcomes following fundoplication. [2022]
Acta from the EndoFLIP® Symposium. [2014]
A novel EndoFLIP marker during hiatal hernia repair is associated with short-term postoperative dysphagia. [2022]
Impedance planimetry (EndoFLIP) assisted laparoscopic esophagomyotomy in pediatric population. [2023]
Assessment of Clinical Outcomes after Peroral Endoscopic Myotomy via Esophageal Distensibility Measurements with the Endoluminal Functional Lumen Imaging Probe. [2020]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security