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

• Sponsor: Foregut Research Foundation (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04695171
• Collaborator: (none)
• Enrollment: 450
• Locations: 4
• Anticipated Duration (Months): 83.5
• Patients Per Site: 112.5
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hiatal Hernia Large; Gastro Esophageal Reflux; Hiatal Hernia; Hiatal Hernia, Paraesophageal; Reflux, Gastroesophageal; Reflux Acid	Device: LINX Reflux Management System; Procedure: Fundoplication

Detailed 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.

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 450 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Cohort Registry on LINX Reflux Management System or Fundoplication Clinical Study in Patients With Hiatal Hernia >3 cm
• Actual Study Start Date: Jan 14, 2021
• Anticipated Primary Completion Date: Jan 1, 2027
• Anticipated Study Completion Date: Jan 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Prior Primary Large Hiatal Hernia with LINX Placement MSA Patients who were previously implanted with the LINX device during repair of a hiatal hernia >3 cm >2 years prior will be asked to complete a quality of life questionnaire at about 3 years and 5 years post procedure. Each participant will complete a barium swallow at 3 and 5 years to determine recurrence of hiatal hernia.	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.; Other Names: Magnetic Augmentation System Magnetic Sphincter Augmentation Device, MSAD Magnetic Sphincter Augmentation, MSA
Prior Primary Large Hiatal Hernia with Fundoplication Patients who previously underwent lower esophageal sphincter reconstruction by fundoplication during repair of a hiatal hernia >3 cm >2 years prior will be asked to complete a quality of life questionnaire at about 3 years and 5 years post procedure. Each participant will complete a barium swallow at about 3 and 5 years to determine recurrence of hiatal hernia.	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.; Other Names: Nissen fundoplication Partial fundoplication Toupet fundoplication Watson fundoplication Dor fundoplication

Outcome Measures

Primary Outcome Measures

1. Incidence of Hiatal Hernia Recurrence [Up to 5 years post index procedure]

   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.

Secondary Outcome Measures

1. Incidence of Repeat Surgical Intervention [5 years]

   A secondary objectives are to determine the incidence of repeat surgical intervention with recurrent hernias in patients who received a LINX verses fundoplication.

2. Understanding Patient Reported Symptom Control [5 years]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Keck Medical Center of USC	Los Angeles	California	United States	90033
2	Institute of Esophageal and Reflux Surgery	Englewood	Colorado	United States	80113
3	Esophageal Institute	Pittsburgh	Pennsylvania	United States	15224
4	Digestive Health	Austin	Texas	United States	78712

Sponsors and Collaborators

• Foregut Research Foundation

Investigators

• Principal Investigator: Reginald Bell, M.D., Principal Investigator

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Foregut Research Foundation
• ClinicalTrials.gov Identifier: NCT04695171
• Other Study ID Numbers: TRX-2019-02
• First Posted: Jan 5, 2021
• Last Update Posted: Jul 26, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Foregut Research Foundation: GERD; LINX; Fundoplication; MSA; Magnetic Sphincter Augmentation; MSAD; Magnetic Sphincter Augmentation Device
• Additional relevant MeSH terms: Gastroesophageal Reflux; Hernia; Hernia, Hiatal

Study Results

No Results Posted as of Jul 26, 2022