Gastroesophageal Reflux Disease Clinical Trial
— ROARSOfficial title:
Registry of Outcomes From AntiReflux Surgery (ROARS)
NCT number | NCT02923362 |
Other study ID # | THF001 |
Secondary ID | |
Status | Active, not recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 2016 |
Est. completion date | May 2025 |
Verified date | February 2023 |
Source | The Heartburn Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Prospective registry comparing outcomes after laparoscopic treatment of gastroesophageal reflux disease and hiatal hernia.
Status | Active, not recruiting |
Enrollment | 2500 |
Est. completion date | May 2025 |
Est. primary completion date | March 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | HealthOne Cardiothoracic Surgery Associates | Aurora | Colorado |
United States | Advanced Surgeons, PC | Birmingham | Alabama |
United States | Suncoast Surgical Associates | Brandon | Florida |
United States | Affinity Medical Group | Chilton | Wisconsin |
United States | South Florida Surgical Specialists, LLC | Coral Springs | Florida |
United States | Baylor Scott and White Research Institute | Dallas | Texas |
United States | Baylor University Medical Center at Dallas | Dallas | Texas |
United States | Institute of Esophageal and Reflux Surgery | Englewood | Colorado |
United States | The Arkansas Heartburn Treatment Center | Heber Springs | Arkansas |
United States | Houston Methodist Research Institute | Houston | Texas |
United States | Mayo Clinic | Jacksonville | Florida |
United States | Froedtert & The Medical College of Wisconsin Hospitals and Health Partners | Milwaukee | Wisconsin |
United States | University of Southern Alabama | Mobile | Alabama |
United States | North Texas Surgical Oncology Associates | Plano | Texas |
United States | Tampa Bay Reflux Center | Riverview | Florida |
United States | Swedish Health Services | Seattle | Washington |
United States | Coastal Carolina Bariatric and Surgical Center | Summerville | South Carolina |
United States | The Tampa Bay Reflux Center | Tampa | Florida |
United States | Bass Medical Group | Walnut Creek | California |
Lead Sponsor | Collaborator |
---|---|
The Heartburn Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quality of Life reported by patient | Standard GERD Quality of Life Assessment | 5 Years |
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