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

Description

The cohort registry is both retrospective and prospective, multicenter surveillance of subjects who underwent a prior hiatal hernia repair and Magnetic Sphincter Augmentation or fundoplication construction more than 2 years prior to initial study visit.

Conditions

Hiatal Hernia Large, Gastro Esophageal Reflux, Hiatal Hernia, Hiatal Hernia, Paraesophageal, Reflux, Gastroesophageal, Reflux Acid

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Study Overview

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Study Details

Study overview

The cohort registry is both retrospective and prospective, multicenter surveillance of subjects who underwent a prior hiatal hernia repair and Magnetic Sphincter Augmentation or fundoplication construction more than 2 years prior to initial study visit.

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

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

Condition
Hiatal Hernia Large
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Keck Medical Center of USC, Los Angeles, California, United States, 90033

Lone Tree

Institute of Esophageal and Reflux Surgery, Lone Tree, Colorado, United States, 80124

Coral Springs

South Florida Reflux Center, Coral Springs, Florida, United States, 33065

Greenville

East Carolina University, Greenville, North Carolina, United States, 27858

Pittsburgh

Esophageal Institute, Pittsburgh, Pennsylvania, United States, 15224

Austin

University of Texas, Austin, Texas, United States, 78712

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

21 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Foregut Research Foundation,

Reginald Bell, M.D., PRINCIPAL_INVESTIGATOR, Principal Investigator

Study Record Dates

2028-01