Gastroesophageal Reflux DiseaseROARSNCT02923362
Registry of Outcomes From AntiReflux Surgery
An observational study of Gastroesophageal Reflux Disease and Hiatal Hernia, run by The Heartburn Foundation at 19 sites in United States.
Trial summary
Prospective registry comparing outcomes after laparoscopic treatment of gastroesophageal reflux disease and hiatal hernia. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Gastroesophageal Reflux Disease, Hiatal Hernia
- What is being tested?
- Laparoscopic Fundoplication and LINX Antireflux
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 1,941 participants
- Where
- 19 sitesUnited States
- Study dates
- May 2016to 3 May 2023
- How long will I take part?
- 5 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: Male and female patient over the age of 21 with no maximum age who meet the eligibility for anti reflux and or hiatal hernia repair surgery
Who may be able to join
- Subject must be at least 21years of age and at least the minimum Age of Majority according to applicable state law.
- Subject is a suitable surgical candidate, i.e. is able to undergo appropriate anesthesia and endoscopic procedure or laparoscopic surgery.
- Appropriate indications for and documentation of disease process requiring surgery. (Documented gastroesophageal reflux disease by accepted endoscopic or ambulatory reflux monitoring criteria, or have a hiatal hernia that meets accepted criteria for repair (e.g. large paraesophageal hernia with chest pain)).
- 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 for the study.
Who cannot join
- Suspected or confirmed esophageal or gastric cancer.
- Cannot understand trial requirements or is unable to comply with follow-up schedule
- Pregnant or nursing, 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
19 sites in 1 country.
19 sites in 1 country
United States19 sites
HealthOne Cardiothoracic Surgery Associates
Aurora, Colorado, 80012
Advanced Surgeons, PC
Birmingham, Alabama, 35243
Suncoast Surgical Associates
Brandon, Florida, 33511
Affinity Medical Group
Chilton, Wisconsin, 53014
South Florida Surgical Specialists, LLC
Coral Springs, Florida, 33065
Baylor Scott and White Research Institute
Dallas, Texas, 75204
Baylor University Medical Center at Dallas
Dallas, Texas, 75246
Institute of Esophageal and Reflux Surgery
Englewood, Colorado, 80113
The Arkansas Heartburn Treatment Center
Heber Springs, Arkansas, 72543
Houston Methodist Research Institute
Houston, Texas, 77030
Mayo Clinic
Jacksonville, Florida, 32224
Froedtert & The Medical College of Wisconsin Hospitals and Health Partners
Milwaukee, Wisconsin, 53226
University of Southern Alabama
Mobile, Alabama, 36617
North Texas Surgical Oncology Associates
Plano, Texas, 75075
Tampa Bay Reflux Center
Riverview, Florida, 33578
Swedish Health Services
Seattle, Washington, 98103
Coastal Carolina Bariatric and Surgical Center
Summerville, South Carolina, 29485
The Tampa Bay Reflux Center
Tampa, Florida, 33609
Bass Medical Group
Walnut Creek, California, 94598
About this study
Official title: Registry of Outcomes From AntiReflux Surgery (ROARS)
Prospective registry comparing outcomes after laparoscopic treatment of gastroesophageal reflux disease and hiatal hernia.
Read the detailed description
This is a prospective, multi center, observational database of patients that are having surgical laparoscopic antireflux procedure and/or hiatal hernia repair, including laparoscopic Nissen fundoplication and Magnetic Sphincter Augmentation with the LINX device. Patients meeting registry inclusion and exclusion will be followed for 5 years with standardized quality of life surveys and appropriate standard of care testing. Up to 40 sites will participate with total enrollment of 1000 patients.
The main objectives are to collect data from everyday clinical practices and track patients from preoperative assessments to 5 years post surgical intervention to evaluate symptoms, medication use and side effects.
- Conditions
- Gastroesophageal Reflux Disease, Hiatal Hernia
- Being tested
- Laparoscopic Fundoplication, LINX Antireflux
- Keywords
- GERD, Reflux, Acid Reflux, Heartburn, Regurgitation, Laryngopharyngeal Reflux, Hiatal Hernia, LPR, LINX, Magnetic Sphincter Augmentation, Antireflux Surgery, Nissen
- Medical subject headings
- Gastroesophageal Reflux, Hernia, Hiatal, Heartburn, Laryngopharyngeal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic FundoplicationProcedure or surgery
Also called Nissen Fundoplication, Fundoplication, Fundoplasty, Hiatal Hernia Repair
The gastric fundus of the stomach is wrapped or plicated around the lower end of the esophagus and and stitched in place reinforcing the closing function of the lower esophageal sphincter. The hiatus is also narrowed down with sutures or mesh to prevent or treat a concurrent hiatal hernia.
LINX AntirefluxDevice
Also called LINX System, LINX Implant, LINX Reflux Management System, LINX Magnetic Sphincter Augmentation
The LINX is a flexible band of interlocked titanium beads with a magnetic core. The LINX is placed around the lower esophageal sphincter to help restore the function of the LES by preventing reflux into the esophagus.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Fundoplication Group | This group of patients are surgical candidates based on preoperative testing results for laparoscopic fundoplication antireflux procedure and possible hiatal hernia repair. | |
| LINX Antireflux Device Group | This group of patients are surgical candidates based on preoperative testing results for the laparoscopic LINX antireflux device placement and possible hiatal hernia repair. Receives: Device: LINX Antireflux |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life reported by patient
Standard GERD Quality of Life Assessment
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 posted4 Oct 2016 (estimated)
- Study startMay 2016
- Primary completion3 May 2023
- Study completion3 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies 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
- 1,941 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- The Heartburn Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reginald Bell, MD, Principal investigator, The Heartburn Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02923362
- Sponsor's protocol ID
- THF001
- Acronym
- ROARS
- Status last verified
- Feb 2023
- First submitted
- 3 Oct 2016
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Outcomes From AntiReflux Surgery (ROARS)
- ClinicalTrials.gov ID
- NCT02923362
- Acronym / sponsor ID
- ROARS / THF001
- Conditions
- Gastroesophageal Reflux Disease, Hiatal Hernia
- Keywords
- GERD, Reflux, Acid Reflux, Heartburn, Regurgitation, Laryngopharyngeal Reflux, Hiatal Hernia, LPR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,941 participants (actual)
- Lead sponsor
- The Heartburn FoundationUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- 3 May 2023 (actual)
- Study completion
- 3 May 2023 (actual)
- First posted
- 4 Oct 2016 (estimated)
- 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.
Prospective registry comparing outcomes after laparoscopic treatment of gastroesophageal reflux disease and hiatal hernia.
Detailed description
This is a prospective, multi center, observational database of patients that are having surgical laparoscopic antireflux procedure and/or hiatal hernia repair, including laparoscopic Nissen fundoplication and Magnetic Sphincter Augmentation with the LINX device. Patients meeting registry inclusion and exclusion will be followed for 5 years with standardized quality of life surveys and appropriate standard of care testing. Up to 40 sites will participate with total enrollment of 1000 patients.
The main objectives are to collect data from everyday clinical practices and track patients from preoperative assessments to 5 years post surgical intervention to evaluate symptoms, medication use and side effects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Fundoplication Group | – | –This group of patients are surgical candidates based on preoperative testing results for laparoscopic fundoplication antireflux procedure and possible hiatal hernia repair. |
| LINX Antireflux Device Group | – | Device: LINX AntirefluxThis group of patients are surgical candidates based on preoperative testing results for the laparoscopic LINX antireflux device placement and possible hiatal hernia repair. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female patient over the age of 21 with no maximum age who meet the eligibility for anti reflux and or hiatal hernia repair surgery
Key inclusion criteria (5 listed)
- Subject must be at least 21years of age and at least the minimum Age of Majority according to applicable state law.
- Subject is a suitable surgical candidate, i.e. is able to undergo appropriate anesthesia and endoscopic procedure or laparoscopic surgery.
- Appropriate indications for and documentation of disease process requiring surgery. (Documented gastroesophageal reflux disease by accepted endoscopic or ambulatory reflux monitoring criteria, or have a hiatal hernia that meets accepted criteria for repair (e.g. large paraesophageal hernia with chest pain)).
- 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 for the study.
Key exclusion criteria (5 listed)
- Suspected or confirmed esophageal or gastric cancer.
- Cannot understand trial requirements or is unable to comply with follow-up schedule
- Pregnant or nursing, 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.
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 |
|---|---|---|
| Laparoscopic FundoplicationAlso: Nissen Fundoplication, Fundoplication, Fundoplasty, Hiatal Hernia RepairThe gastric fundus of the stomach is wrapped or plicated around the lower end of the esophagus and and stitched in place reinforcing the closing function of the lower esophageal sphincter. The hiatus is also narrowed down with sutures or mesh to prevent or treat a concurrent hiatal hernia. | Procedure or surgery | – |
| LINX AntirefluxAlso: LINX System, LINX Implant, LINX Reflux Management System, LINX Magnetic Sphincter AugmentationThe LINX is a flexible band of interlocked titanium beads with a magnetic core. The LINX is placed around the lower esophageal sphincter to help restore the function of the LES by preventing reflux into the esophagus. | Device | LINX Antireflux Device Group |
Primary outcome
Quality of Life reported by patient
Time frame: 5 Years
Standard GERD Quality of Life Assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No
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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, MD principal investigator
The Heartburn Foundation
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux Disease and Hiatal Hernia, run by The Heartburn Foundation at 19 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quality of Life reported by patient (time frame: 5 Years). 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 7 Aug 2026.