Hiatal Hernia LargeNCT04695171
LINX Reflux Management System or Fundoplication Clinical Study in Patients With Hiatal Hernia >3 cm
An observational study of Hiatal Hernia Large and Gastro Esophageal Reflux, run by Foregut Research Foundation at 6 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hiatal Hernia Large, Gastro Esophageal Reflux, Hiatal Hernia
- What is being tested?
- LINX Reflux Management System and Fundoplication
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 336 participants
- Where
- 6 sitesUnited States
- Study dates
- 14 Jan 2021to 14 Jan 2026
- How long will I take part?
- 6 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This clinical evaluation will be conducted at four U.S. investigational centers with up to one hundred and fifty(150) subjects per center (goal of 450 total). Corhort 1 will consist of 300 subjects who were implanted with the LINX® Reflux Management System in the manner described above more than 2 years prior to enrollment to this study. Cohort 2 will consist of 150 subjects who underwent a fundoplication more that 2 years prior to enrollment into this study with similar hiatal hernia size and similar effective esophageal motility.
Who may be able to join
- Subject must be at least 21 years of age and at least the minimum Age of Majority according to applicable state law.
- 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.
- Subject is willing and able to cooperate with follow-up examinations.
- Subject has been informed of the study procedures and treatment and has signed an informed consent.
Who cannot join
- The surgical procedure was completed as an emergency procedure
- Currently being treated with another investigational drug or investigational device
- Suspected or confirmed esophageal or gastric cancer
- Subject has Barrett's esophagus >3cm
- Cannot understand trial requirements or is unable to comply with follow-up schedule
- Pregnant or plans to become pregnant during the course of the study
- 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)
- Diagnosed psychiatric disorder (e.g. bipolar, schizophrenia, etc.), subjects that exhibit depression that are on appropriate medication(s) are allowable.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Texas
Austin, Texas, 78712
South Florida Reflux Center
Coral Springs, Florida, 33065
East Carolina University
Greenville, North Carolina, 27858
Institute of Esophageal and Reflux Surgery
Lone Tree, Colorado, 80124
Keck Medical Center of USC
Los Angeles, California, 90033
Esophageal Institute
Pittsburgh, Pennsylvania, 15224
About this study
Official title: Cohort Registry on LINX Reflux Management System or Fundoplication Clinical Study in Patients With Hiatal Hernia >3 cm
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.
Read the 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.
- Conditions
- Hiatal Hernia Large, Gastro Esophageal Reflux, Hiatal Hernia, Hiatal Hernia, Paraesophageal, Reflux, Gastroesophageal, Reflux Acid
- Being tested
- LINX Reflux Management System, Fundoplication
- Keywords
- GERD, LINX, Fundoplication, MSA, Magnetic Sphincter Augmentation, MSAD, Magnetic Sphincter Augmentation Device
- Medical subject headings
- Gastroesophageal Reflux, Hernia, Hiatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LINX Reflux Management SystemDevice
Also called Magnetic Augmentation System, Magnetic Sphincter Augmentation Device, MSAD, Magnetic Sphincter Augmentation, MSA
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.
FundoplicationProcedure or surgery
Also called Nissen fundoplication, Partial fundoplication, Toupet fundoplication, Watson 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: LINX Reflux Management System | |
| 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. Receives: Procedure: Fundoplication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 5 years post index procedure
Secondary outcomes (2)
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.
Measured: 5 years
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start14 Jan 2021
- Primary completion14 Jan 2026
- Study completion14 Jan 2026
Why it stopped: The study was terminated early. The sponsor will focus on prospective randomized controlled studies at this time. Funding removed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hiatal Hernia LargeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 336 participants (actual)
- Target duration
- 6 Years
Sponsor and investigators
- Lead sponsor
- Foregut Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reginald Bell, M.D., Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04695171
- Sponsor's protocol ID
- TRX-2019-02
- Status last verified
- Feb 2026
- First submitted
- 31 Dec 2020
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Registry on LINX Reflux Management System or Fundoplication Clinical Study in Patients With Hiatal Hernia >3 cm
- ClinicalTrials.gov ID
- NCT04695171
- Acronym / sponsor ID
- TRX-2019-02
- Conditions
- Hiatal Hernia Large, Gastro Esophageal Reflux, Hiatal Hernia, Hiatal Hernia, Paraesophageal, Reflux, Gastroesophageal, Reflux Acid
- Keywords
- GERD, LINX, Fundoplication, MSA, Magnetic Sphincter Augmentation, MSAD, Magnetic Sphincter Augmentation Device
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was terminated early. The sponsor will focus on prospective randomized controlled studies at this time. Funding removed.
- Enrolment
- 336 participants (actual)
- Lead sponsor
- Foregut Research FoundationUniversity, hospital or other
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- 14 Jan 2026 (actual)
- Study completion
- 14 Jan 2026 (actual)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prior Primary Large Hiatal Hernia with LINX Placement MSA | – | Device: LINX Reflux Management SystemPatients 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. |
| Prior Primary Large Hiatal Hernia with Fundoplication | – | Procedure: FundoplicationPatients 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This clinical evaluation will be conducted at four U.S. investigational centers with up to one hundred and fifty(150) subjects per center (goal of 450 total). Corhort 1 will consist of 300 subjects who were implanted with the LINX® Reflux Management System in the manner described above more than 2 years prior to enrollment to this study. Cohort 2 will consist of 150 subjects who underwent a fundoplication more that 2 years prior to enrollment into this study with similar hiatal hernia size and similar effective esophageal motility.
Key inclusion criteria (4 listed)
- Subject must be at least 21 years of age and at least the minimum Age of Majority according to applicable state law.
- 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.
- Subject is willing and able to cooperate with follow-up examinations.
- Subject has been informed of the study procedures and treatment and has signed an informed consent.
Key exclusion criteria (8 listed)
- The surgical procedure was completed as an emergency procedure
- Currently being treated with another investigational drug or investigational device
- Suspected or confirmed esophageal or gastric cancer
- Subject has Barrett's esophagus >3cm
- Cannot understand trial requirements or is unable to comply with follow-up schedule
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LINX Reflux Management SystemAlso: Magnetic Augmentation System, Magnetic Sphincter Augmentation Device, MSAD, Magnetic Sphincter Augmentation, MSAThe 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. | Device | Prior Primary Large Hiatal Hernia with LINX Placement MSA |
| FundoplicationAlso: Nissen fundoplication, Partial fundoplication, Toupet fundoplication, Watson fundoplicationA 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. | Procedure or surgery | Prior Primary Large Hiatal Hernia with Fundoplication |
Primary outcome
Incidence of Hiatal Hernia Recurrence
Time frame: 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.
2 secondary outcomes
Incidence of Repeat Surgical Intervention
Time frame: 5 years
Understanding Patient Reported Symptom Control
Time frame: 5 years
Results and safety
The study was stopped early (reason given: The study was terminated early. The sponsor will focus on prospective randomized controlled studies at this time. Funding removed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reginald Bell, M.D. principal investigator
Principal Investigator
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hiatal Hernia Large and Gastro Esophageal Reflux, run by Foregut Research Foundation at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was terminated early. The sponsor will focus on prospective randomized controlled studies at this time. Funding removed.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Hiatal Hernia Recurrence (time frame: Up to 5 years post index procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.