LINX Reflux Management System or Fundoplication Clinical Study in Patients With Hiatal Hernia >3 cm

Launched by FOREGUT RESEARCH FOUNDATION · Jan 4, 2021

Keywords

ClinConnect Summary

The LINX Reflux Management System or Fundoplication Clinical Study is researching the effectiveness of two surgical treatments for large hiatal hernias (greater than 3 cm) in patients who have already undergone surgery for this condition. The study involves patients who had either a LINX device placed or a fundoplication procedure done more than two years ago. Researchers are interested in how well these treatments control acid reflux, a common issue where stomach acid flows back into the esophagus, causing discomfort.

To be eligible for this study, participants must be at least 21 years old, have had a previous surgery for a hiatal hernia larger than 3 cm, and be willing to attend follow-up appointments. This study is open to all genders and aims to gather information to help improve future treatments. If you decide to participate, you will undergo evaluations to monitor your condition and the effectiveness of the treatment you received. It’s important to note that this study cannot include individuals with certain medical conditions, such as esophageal or gastric cancer, or those currently pregnant.

Gender

ALL

Eligibility 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.