RECRUITING

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

Conditions

Hiatal Hernia Large Gastro Esophageal Reflux Hiatal Hernia Hiatal Hernia, Paraesophageal Reflux, Gastroesophageal Reflux Acid GERD LINX Fundoplication MSA Magnetic Sphincter Augmentation MSAD Magnetic Sphincter Augmentation Device

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-01-14

Study Completion:2028-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04695171

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.

Ages Eligible for Study:21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Rachel Heidrick, BSN

CONTACT

303-788-7700

rachel@iersurgery.com

Principal Investigator

Reginald Bell, M.D.

PRINCIPAL_INVESTIGATOR

Principal Investigator

Study Locations (Sites)

Keck Medical Center of USC

Los Angeles, California, 90033

United States

Institute of Esophageal and Reflux Surgery

Lone Tree, Colorado, 80124

United States

South Florida Reflux Center

Coral Springs, Florida, 33065

United States

East Carolina University

Greenville, North Carolina, 27858

United States

Esophageal Institute

Pittsburgh, Pennsylvania, 15224

United States

University of Texas

Austin, Texas, 78712

United States

Collaborators and Investigators

Sponsor: Foregut Research Foundation

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-01-14

Study Completion Date2028-01

Study Record Updates

Study Start Date2021-01-14

Study Completion Date2028-01

Terms related to this study

Keywords Provided by Researchers

GERD
LINX
Fundoplication
MSA
Magnetic Sphincter Augmentation
MSAD
Magnetic Sphincter Augmentation Device

Additional Relevant MeSH Terms

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