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

Gastro Esophageal Reflux Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04695171
• Other study ID #: TRX-2019-02
• Status: Recruiting
• Start date: January 14, 2021
• Est. completion date: January 2028

Study information

• Verified date: September 2023
• Source: Foregut Research Foundation
• Contact: Rachel Heidrick, BSN
• Phone: 303-788-7700
• Email: rachel[@]iersurgery.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

The cohort registry is both retrospective and prospective, multicenter surveillance of subjects who underwent a prior hiatal hernia repair and anti-reflux surgery with either Magnetic Sphincter Augmentation (MSA) using LINX placement or fundoplication construction more than 2 years prior to initial study visit. Subjects will be enrolled by invitation only by participating investigators. Enrollment will consist of 300 LINX MSA patients and 150 fundoplication patients with a total of 450 from 4 sites within the United States. Data will be collected for up to 6 years.The primary objective of this study is to determine the long-term incidence of hiatal hernia recurrence in patients who undergo hiatal hernia repair of a large (>3 cm) hernia with LINX® device placement, and to compare this with hiatal hernia recurrence rates in patients who underwent hiatal hernia repair with fundoplication.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: January 2028
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• LINX Reflux Management System
The LINX Reflux Management System consists of a series of titanium beads each with a magnetic core connected with independent titanium wires to form an annular shape when implanted. The attractive force of the magnetic beads is designed to provide additional strength to keep a weak lower esophageal sphincter (LES) closed. During swallowing, the magnetic beads slide away from each other on the independent titanium wire "links" to allow esophageal distention as the bolus passes by.

Procedure:
• Fundoplication
A surgical procedure where the fundus of the stomach is wrapped around and sutured to the distal esophagus to restore the function of the lower esophageal sphincter in limiting stomach contents from refluxing into the esophagus.

Locations

Country	Name	City	State
United States	University of Texas	Austin	Texas
United States	South Florida Reflux Center	Coral Springs	Florida
United States	East Carolina University	Greenville	North Carolina
United States	Institute of Esophageal and Reflux Surgery	Lone Tree	Colorado
United States	Keck Medical Center of USC	Los Angeles	California
United States	Esophageal Institute	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Foregut Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Hiatal Hernia Recurrence	The primary objective of this study is to determine the long-term incidence of hiatal hernia recurrence in patients who undergo primary hiatal hernia repair of a large (>3 cm) hernia with LINX® device placement, and to compare this with hiatal hernia recurrence rates in patients who undergo hiatal hernia repair with fundoplication.	Up to 5 years post index procedure
Secondary	Incidence of Repeat Surgical Intervention	A secondary objectives are to determine the incidence of repeat surgical intervention with recurrent hernias in patients who received a LINX verses fundoplication.	5 years
Secondary	Understanding Patient Reported Symptom Control	A secondary objective is to understand patient-reported symptom control including PPI use, occurrence rate of gas and bloating, and ability to belch and vomit as measured by comparison of pre- and post-operative satisfaction and ROARS Questionnaire (GERD-Health related quality of life [HRQL]) surveys during multiple follow-up time points.	5 years