Comparing LINX device and fundoplication for large hiatal hernias
Cohort Registry on LINX Reflux Management System or Fundoplication Clinical Study in Patients With Hiatal Hernia >3 cm
This study is trying to see which surgery, the LINX device or fundoplication, works better for preventing hiatal hernias from coming back in patients who had their surgery over two years ago.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 450 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Foregut Research Foundation Academic / other |
| Locations | 6 sites (Los Angeles, California and 5 other locations) |
| Trial ID | NCT04695171 on ClinicalTrials.gov |
What this trial studies
This observational cohort registry involves both retrospective and prospective data collection from patients who have previously undergone hiatal hernia repair with either Magnetic Sphincter Augmentation (LINX) or fundoplication. The study aims to enroll 450 patients across four sites in the United States, focusing on those who had their surgeries more than two years prior. The primary goal is to assess the long-term recurrence rates of hiatal hernias in these two surgical approaches over a follow-up period of up to six years.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and older who have undergone laparoscopic repair of a hiatal hernia larger than 3 cm with either LINX placement or fundoplication more than two years ago.
Not a fit: Patients who had emergency surgical procedures or those with esophageal or gastric cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of LINX versus fundoplication in preventing hiatal hernia recurrence.
How similar studies have performed: Previous studies have shown promising results with similar surgical approaches, but this specific comparison of LINX and fundoplication in large hiatal hernias is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Subject must be at least 21 years of age and at least the minimum Age of Majority according to applicable state law. 2. Underwent primary index procedure of laparoscopic repair of a hiatal hernia larger than 3 cm with placement of a LINX® device or construction of a fundoplication for reflux control more than 2 years prior to his/her enrollment or has completed 1 or 2 of the barium swallows and GERD-HRQLs within study time points with or without hiatal hernia recurrence. 3. Subject is willing and able to cooperate with follow-up examinations. 4. Subject has been informed of the study procedures and treatment and has signed an informed consent. Exclusion Criteria: 1. The surgical procedure was completed as an emergency procedure 2. Currently being treated with another investigational drug or investigational device 3. Suspected or confirmed esophageal or gastric cancer 4. Subject has Barrett's esophagus \>3cm 5. Cannot understand trial requirements or is unable to comply with follow-up schedule 6. Pregnant or plans to become pregnant during the course of the study 7. Medical illness (i.e. congestive heart failure) that may cause the subject to be non-compliant with or able to meet the protocol requirements or is associated with limited life expectancy (i.e. less than 3 years) 8. Diagnosed psychiatric disorder (e.g. bipolar, schizophrenia, etc.), subjects that exhibit depression that are on appropriate medication(s) are allowable.
Where this trial is running
Los Angeles, California and 5 other locations
- Keck Medical Center of USC — Los Angeles, California, United States (Recruiting)
- Institute of Esophageal and Reflux Surgery — Lone Tree, Colorado, United States (Recruiting)
- South Florida Reflux Center — Coral Springs, Florida, United States (Recruiting)
- East Carolina University — Greenville, North Carolina, United States (Recruiting)
- Esophageal Institute — Pittsburgh, Pennsylvania, United States (Active_not_recruiting)
- University of Texas — Austin, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Reginald Bell, M.D. — Principal Investigator
- Study coordinator: Rachel Heidrick, BSN
- Email: rachel@iersurgery.com
- Phone: 303-788-7700
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.