GERDROSENCT03705416
Long Term Outcomes of Bariatric Patients Treated With Surgery or Endoscopy
An observational study of GERD and Obesity, run by Johns Hopkins University at 6 sites in United States.
Trial summary
GERD is common in the obese population. Bariatric procedures are the mainstay of therapy for these patients. Bariatric procedures can be surgical (Roux-en-Y gastric bypass and Vertical sleeve gastrectomy) or endoscopic (endoscopic sleeve gastroplasty). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- What is being tested?
- Endoscopy and Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 6 sitesUnited States
- Study dates
- 30 Mar 2019to 30 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- Adult, Older adult
Study population: Obese patients with BMI 30 scheduled to undergo a bariatric interventions (endoscopic and surgical) at multiple academic medical centers in the United States offering both treatments.
Who may be able to join
- BMI ≥ 30 Kg/m2
- Patients scheduled to undergo a bariatric weight loss procedure (endoscopic or surgical)
- Patients older than 18 years and younger than 75 years of age at time of consent
- Patients able to provide written informed consent on the Institutional review board (IRB) approved informed consent form
- Patients willing and able to comply with study requirements for follow-up
Who cannot join
- Any patient with BMI < 30 Kg/m2
- Patients treated with intragastric balloons.
- Pre-existing esophageal stenosis/stricture preventing advancement of an endoscope during screening/baseline Esophagogastroduodenoscopy (EGD)
- Esophageal, gastric or duodenal malignancy
- Severe medical comorbidities precluding endoscopy, or limiting life expectancy to less than 2 years in the judgment of the endoscopist
- Uncontrolled coagulopathy or inability to be off anticoagulation or anti-platelet medication (ASA, Plavix) for 1 week prior to and 2 weeks after each endoscopy
Show all 13Show fewer
- Active fungal esophagitis
- Known portal hypertension, visible esophageal or gastric varices, or history of esophageal varices
- General poor health, multiple co-morbidities placing the patient at risk, or otherwise unsuitable for trial participation
- Pregnant or planning to become pregnant during period of study participation
- Patient refuses or is unable to provide written informed consent
- Prior bariatric treatment procedure
- Prior surgical or endoscopic anti-reflux procedure
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Johns Hopkins University
Baltimore, Maryland, 21287
Memorial Hermann Health System
Houston, Texas, 77401
Northwell Health
New Hyde Park, New York, 11040
Weill Cornell
New York, New York, 10021
Legacy Oregon Clinic
Portland, Oregon, 97213
Utah-Health: University of Utah
Salt Lake City, Utah, 84132
About this study
Official title: Reflux in the Obese Undergoing Surgery or Endoscopy (ROSE) Previously: Gastroesophageal Reflux Disease (GERD) in Bariatric Patients
GERD is common in the obese population. Bariatric procedures are the mainstay of therapy for these patients. Bariatric procedures can be surgical (Roux-en-Y gastric bypass and Vertical sleeve gastrectomy) or endoscopic (endoscopic sleeve gastroplasty). The rate of GERD after either treatment is unknown as is the rate of silent reflux. The study primary objective is to assess the incidence rate of GERD in bariatric patients that undergo either therapy.
Read the detailed description
GERD is a prevalent condition worldwide, estimated to be around 20-30 % in North America. Obesity is rapidly increasing with an estimated prevalence of 66% in the adult population in the United States. GERD symptoms are common in the obese population with data showing weekly GERD symptoms in 34.6% and erosive esophagitis 26.9% in people with BMI > 30 Kg/m2.
Presently, bariatric procedures are the only sustainable method to address morbid obesity and its resulting comorbidities. There are endoscopic and surgical bariatric procedures. The natural history of GERD symptoms in this population after undergoing a bariatric treatment is scarce or conflicting. Moreover, silent or asymptomatic GERD prevalence has not been well established preoperatively. Evaluation and documentation of GERD may potentially change the planned bariatric procedure and avoid unnecessary additional surgeries or procedures to address symptomatic post-operative GERD.
The investigators hypothesized that GERD is more prevalent in patients undergoing surgical bariatric procedures, specifically laparoscopic vertical sleeve gastrectomy (VSG). This multi-center, prospective, cohort study can potentially clarify current debatable data, based mostly on retrospective studies, and can help clinicians to select the most appropriate bariatric treatment for the patients. Most importantly, by selecting the best approach based on preoperative GERD studies it could prevent long term complications of GERD and further unnecessary procedures for the bariatric patient.
- Being tested
- Endoscopy, Surgery
- Keywords
- GERD, Bariatric surgery, Endoscopic sleeve gastroplasty, Sleeve gastrectomy, Roux-en-Y gastric bypass
- Medical subject headings
- Gastroesophageal Reflux, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoscopyProcedure or surgery
Also called Endoscopic sleeve gastroplasty or ESG
endoscopic suturing of stomach
SurgeryProcedure or surgery
Also called Surgical reduction or bypass
Vertical sleeve gastrectomy (VSG) surgical reduction of stomach, or (RYGBP) , or gastric bypass procedure
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic sleeve gastroplasty | All obese patients who will be undergoing an endoscopic sleeve gastroplasty (ESG). As part of the standard of care this patients will have a preoperative gastroscopy with wireless pH monitoring. Then after the endoscopic sleeve gastroplasty patients will be followed up regarding GERD symptoms for 5 years. As part of the standard of care a follow up endoscopy will be done at year 1 and wireless pH monitoring will be performed Receives: Procedure: Endoscopy | |
| Surgery (VSG or RYGBP) | All obese patients who will be undergoing either a vertical sleeve gastrectomy or a Roux-en-Y gastric bypass. As part of the standard of care this patients will have a preoperative gastroscopy with wireless pH monitoring. Then after the surgical procedure patients will be followed up regarding GERD symptoms for 5 years. As part of the standard of care a follow up endoscopy will be done at year 1 and wireless pH monitoring will be performed Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with GERD based on symptoms, and abnormal acid exposure time and/or reflux esophagitis
GERD symptoms, esophageal acid exposure time and/or esophagitis
Measured: 1 year
Secondary outcomes (9)
Difference in BMI after the bariatric procedure
change in weight in Kg and height in m (BMI=Kg/m) before and after treatment
Measured: 5 years
Reflux esophagitis
Incidence of GERD-related complications
Measured: 5 years
GERD severity based on standardized Reflux Disease Questionnaire (RDQ)
GERD severity based on standardized Reflux Disease Questionnaire (RDQ) questionnaire (score 12-72; the greater the score, the greater the severity)
Measured: 3,6,12,24,26,48, and 60 months post procedure
GERD severity as assessed by GERD-Health related quality of life (HRQL) score
GERD-Health related quality of life (HRQL) score (score 0-53; the greater the score,the worse the quality of life) will be used for this assessment
Measured: 3,6,12,24,26,48, and 60 months post procedure
Percentage of participants on daily or twice daily PPI for GERD symptoms control, regardless of pH-monitoring results
Proportion of patients being treated with medication (PPI)
Measured: 5 years
Percent of patients with abnormal esophageal acid exposure time > 6% defined by Bravo pH monitoring (96 hours)
Abnormal esophageal acid exposure time (AET)
Measured: 1 year
Percentage of excess body weight (EBW) loss and total body weight loss (TBWL)
Change in body weight after treatment with endoscopy and surgery (compare groups)
Measured: 5 years
Prevalence and incidence of silent reflux
Proportion of patients with abnormal AET without symptoms after bariatric treatment procedure
Measured: 1 year
Percentage of patients with GERD at baseline in whom the planned bariatric intervention was changed due to abnormal ph testing or presence of erosive esophagitis, Barrett's esophagus, reflux related esophageal stricture
Proportion of patients with change in treatment plan after diagnostic evaluation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start30 Mar 2019
- Primary completionDec 2026 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for GERDStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marcia I Canto, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03705416
- Sponsor's protocol ID
- IRB00186052
- Other IDs
- The ROSE study
- Acronym
- ROSE
- Status last verified
- Aug 2026
- First submitted
- 21 Sep 2018
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Research projects will be submitted to host (currently JHU) and accepted project will be granted access to read only de-identified database.
Publications
Vakil N, van Zanten SV, Kahrilas P, Dent J, Jones R; Global Consensus Group. The Montreal definition and classification of gastroesophageal reflux disease: a global evidence-based consensus. Am J Gastroenterol. 2006 Aug;101(8):1900-20; quiz 1943. doi: 10.1111/j.1572-0241.2006.00630.x.
PubMed 16928254Tutuian R. Obesity and GERD: pathophysiology and effect of bariatric surgery. Curr Gastroenterol Rep. 2011 Jun;13(3):205-12. doi: 10.1007/s11894-011-0191-y.
PubMed 21424733Singh M, Lee J, Gupta N, Gaddam S, Smith BK, Wani SB, Sullivan DK, Rastogi A, Bansal A, Donnelly JE, Sharma P. Weight loss can lead to resolution of gastroesophageal reflux disease symptoms: a prospective intervention trial. Obesity (Silver Spring). 2013 Feb;21(2):284-90. doi: 10.1002/oby.20279.
PubMed 23532991Borbely Y, Schaffner E, Zimmermann L, Huguenin M, Plitzko G, Nett P, Kroll D. De novo gastroesophageal reflux disease after sleeve gastrectomy: role of preoperative silent reflux. Surg Endosc. 2019 Mar;33(3):789-793. doi: 10.1007/s00464-018-6344-4. Epub 2018 Jul 12.
PubMed 30003346El-Serag HB, Graham DY, Satia JA, Rabeneck L. Obesity is an independent risk factor for GERD symptoms and erosive esophagitis. Am J Gastroenterol. 2005 Jun;100(6):1243-50. doi: 10.1111/j.1572-0241.2005.41703.x.
PubMed 15929752Kurian M, Kroh M, Chand B, Mikami D, Reavis K, Khaitan L. SAGES review of endoscopic and minimally invasive bariatric interventions: a review of endoscopic and non-surgical bariatric interventions. Surg Endosc. 2018 Oct;32(10):4063-4067. doi: 10.1007/s00464-018-6238-5. Epub 2018 May 29.
PubMed 29845397Chung AY, Thompson R, Overby DW, Duke MC, Farrell TM. Sleeve Gastrectomy: Surgical Tips. J Laparoendosc Adv Surg Tech A. 2018 Aug;28(8):930-937. doi: 10.1089/lap.2018.0392. Epub 2018 Jul 13.
PubMed 30004814Schlottmann F, Buxhoeveden R. Laparoscopic Roux-en-Y Gastric Bypass: Surgical Technique and Tips for Success. J Laparoendosc Adv Surg Tech A. 2018 Aug;28(8):938-943. doi: 10.1089/lap.2018.0393. Epub 2018 Jul 16.
PubMed 30010475Rebecchi F, Allaix ME, Giaccone C, Ugliono E, Scozzari G, Morino M. Gastroesophageal reflux disease and laparoscopic sleeve gastrectomy: a physiopathologic evaluation. Ann Surg. 2014 Nov;260(5):909-14; discussion 914-5. doi: 10.1097/SLA.0000000000000967.
PubMed 25379861Burgerhart JS, Schotborgh CA, Schoon EJ, Smulders JF, van de Meeberg PC, Siersema PD, Smout AJ. Effect of sleeve gastrectomy on gastroesophageal reflux. Obes Surg. 2014 Sep;24(9):1436-41. doi: 10.1007/s11695-014-1222-1.
PubMed 24619293Oor JE, Roks DJ, Unlu C, Hazebroek EJ. Laparoscopic sleeve gastrectomy and gastroesophageal reflux disease: a systematic review and meta-analysis. Am J Surg. 2016 Jan;211(1):250-67. doi: 10.1016/j.amjsurg.2015.05.031. Epub 2015 Aug 14.
PubMed 26341463
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reflux in the Obese Undergoing Surgery or Endoscopy (ROSE) Previously: Gastroesophageal Reflux Disease (GERD) in Bariatric Patients
- ClinicalTrials.gov ID
- NCT03705416
- Acronym / sponsor ID
- ROSE / IRB00186052
- Keywords
- GERD, Bariatric surgery, Endoscopic sleeve gastroplasty, Sleeve gastrectomy, Roux-en-Y gastric bypass
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 30 Mar 2019 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 15 Oct 2018 (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.
GERD is common in the obese population. Bariatric procedures are the mainstay of therapy for these patients. Bariatric procedures can be surgical (Roux-en-Y gastric bypass and Vertical sleeve gastrectomy) or endoscopic (endoscopic sleeve gastroplasty). The rate of GERD after either treatment is unknown as is the rate of silent reflux. The study primary objective is to assess the incidence rate of GERD in bariatric patients that undergo either therapy.
Detailed description
GERD is a prevalent condition worldwide, estimated to be around 20-30 % in North America. Obesity is rapidly increasing with an estimated prevalence of 66% in the adult population in the United States. GERD symptoms are common in the obese population with data showing weekly GERD symptoms in 34.6% and erosive esophagitis 26.9% in people with BMI > 30 Kg/m2.
Presently, bariatric procedures are the only sustainable method to address morbid obesity and its resulting comorbidities. There are endoscopic and surgical bariatric procedures. The natural history of GERD symptoms in this population after undergoing a bariatric treatment is scarce or conflicting. Moreover, silent or asymptomatic GERD prevalence has not been well established preoperatively. Evaluation and documentation of GERD may potentially change the planned bariatric procedure and avoid unnecessary additional surgeries or procedures to address symptomatic post-operative GERD.
The investigators hypothesized that GERD is more prevalent in patients undergoing surgical bariatric procedures, specifically laparoscopic vertical sleeve gastrectomy (VSG). This multi-center, prospective, cohort study can potentially clarify current debatable data, based mostly on retrospective studies, and can help clinicians to select the most appropriate bariatric treatment for the patients. Most importantly, by selecting the best approach based on preoperative GERD studies it could prevent long term complications of GERD and further unnecessary procedures for the bariatric patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic sleeve gastroplasty | – | Procedure: EndoscopyAll obese patients who will be undergoing an endoscopic sleeve gastroplasty (ESG). As part of the standard of care this patients will have a preoperative gastroscopy with wireless pH monitoring. Then after the endoscopic sleeve gastroplasty patients will be followed up regarding GERD symptoms for 5 years. As part of the standard of care a follow up endoscopy will be done at year 1 and wireless pH monitoring will be performed |
| Surgery (VSG or RYGBP) | – | Procedure: SurgeryAll obese patients who will be undergoing either a vertical sleeve gastrectomy or a Roux-en-Y gastric bypass. As part of the standard of care this patients will have a preoperative gastroscopy with wireless pH monitoring. Then after the surgical procedure patients will be followed up regarding GERD symptoms for 5 years. As part of the standard of care a follow up endoscopy will be done at year 1 and wireless pH monitoring will be performed |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Obese patients with BMI 30 scheduled to undergo a bariatric interventions (endoscopic and surgical) at multiple academic medical centers in the United States offering both treatments.
Key inclusion criteria (5 listed)
- BMI ≥ 30 Kg/m2
- Patients scheduled to undergo a bariatric weight loss procedure (endoscopic or surgical)
- Patients older than 18 years and younger than 75 years of age at time of consent
- Patients able to provide written informed consent on the Institutional review board (IRB) approved informed consent form
- Patients willing and able to comply with study requirements for follow-up
Key exclusion criteria (13 listed)
- Any patient with BMI < 30 Kg/m2
- Patients treated with intragastric balloons.
- Pre-existing esophageal stenosis/stricture preventing advancement of an endoscope during screening/baseline Esophagogastroduodenoscopy (EGD)
- Esophageal, gastric or duodenal malignancy
- Severe medical comorbidities precluding endoscopy, or limiting life expectancy to less than 2 years in the judgment of the endoscopist
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 |
|---|---|---|
| EndoscopyAlso: Endoscopic sleeve gastroplasty or ESGendoscopic suturing of stomach | Procedure or surgery | Endoscopic sleeve gastroplasty |
| SurgeryAlso: Surgical reduction or bypassVertical sleeve gastrectomy (VSG) surgical reduction of stomach, or (RYGBP) , or gastric bypass procedure | Procedure or surgery | Surgery (VSG or RYGBP) |
Primary outcome
Percentage of participants with GERD based on symptoms, and abnormal acid exposure time and/or reflux esophagitis
Time frame: 1 year
GERD symptoms, esophageal acid exposure time and/or esophagitis
9 secondary outcomes
Difference in BMI after the bariatric procedure
Time frame: 5 years
Reflux esophagitis
Time frame: 5 years
GERD severity based on standardized Reflux Disease Questionnaire (RDQ)
Time frame: 3,6,12,24,26,48, and 60 months post procedure
GERD severity as assessed by GERD-Health related quality of life (HRQL) score
Time frame: 3,6,12,24,26,48, and 60 months post procedure
Percentage of participants on daily or twice daily PPI for GERD symptoms control, regardless of pH-monitoring results
Time frame: 5 years
Percent of patients with abnormal esophageal acid exposure time > 6% defined by Bravo pH monitoring (96 hours)
Time frame: 1 year
Percentage of excess body weight (EBW) loss and total body weight loss (TBWL)
Time frame: 5 years
Prevalence and incidence of silent reflux
Time frame: 1 year
Percentage of patients with GERD at baseline in whom the planned bariatric intervention was changed due to abnormal ph testing or presence of erosive esophagitis, Barrett's esophagus, reflux related esophageal stricture
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Background: PubMed 16928254Vakil N, van Zanten SV, Kahrilas P, Dent J, Jones R; Global Consensus Group. The Montreal definition and classification of gastroesophageal reflux disease: a global evidence-based consensus. Am J Gastroenterol. 2006 Aug;101(8):1900-20; quiz 1943. doi: 10.1111/j.1572-0241.2006.00630.x.
- Background: PubMed 21424733Tutuian R. Obesity and GERD: pathophysiology and effect of bariatric surgery. Curr Gastroenterol Rep. 2011 Jun;13(3):205-12. doi: 10.1007/s11894-011-0191-y.
- Background: PubMed 23532991Singh M, Lee J, Gupta N, Gaddam S, Smith BK, Wani SB, Sullivan DK, Rastogi A, Bansal A, Donnelly JE, Sharma P. Weight loss can lead to resolution of gastroesophageal reflux disease symptoms: a prospective intervention trial. Obesity (Silver Spring). 2013 Feb;21(2):284-90. doi: 10.1002/oby.20279.
- Background: PubMed 30003346Borbely Y, Schaffner E, Zimmermann L, Huguenin M, Plitzko G, Nett P, Kroll D. De novo gastroesophageal reflux disease after sleeve gastrectomy: role of preoperative silent reflux. Surg Endosc. 2019 Mar;33(3):789-793. doi: 10.1007/s00464-018-6344-4. Epub 2018 Jul 12.
- Background: PubMed 15929752El-Serag HB, Graham DY, Satia JA, Rabeneck L. Obesity is an independent risk factor for GERD symptoms and erosive esophagitis. Am J Gastroenterol. 2005 Jun;100(6):1243-50. doi: 10.1111/j.1572-0241.2005.41703.x.
- Background: PubMed 29845397Kurian M, Kroh M, Chand B, Mikami D, Reavis K, Khaitan L. SAGES review of endoscopic and minimally invasive bariatric interventions: a review of endoscopic and non-surgical bariatric interventions. Surg Endosc. 2018 Oct;32(10):4063-4067. doi: 10.1007/s00464-018-6238-5. Epub 2018 May 29.
- Background: PubMed 30004814Chung AY, Thompson R, Overby DW, Duke MC, Farrell TM. Sleeve Gastrectomy: Surgical Tips. J Laparoendosc Adv Surg Tech A. 2018 Aug;28(8):930-937. doi: 10.1089/lap.2018.0392. Epub 2018 Jul 13.
- Background: PubMed 30010475Schlottmann F, Buxhoeveden R. Laparoscopic Roux-en-Y Gastric Bypass: Surgical Technique and Tips for Success. J Laparoendosc Adv Surg Tech A. 2018 Aug;28(8):938-943. doi: 10.1089/lap.2018.0393. Epub 2018 Jul 16.
- Background: PubMed 25379861Rebecchi F, Allaix ME, Giaccone C, Ugliono E, Scozzari G, Morino M. Gastroesophageal reflux disease and laparoscopic sleeve gastrectomy: a physiopathologic evaluation. Ann Surg. 2014 Nov;260(5):909-14; discussion 914-5. doi: 10.1097/SLA.0000000000000967.
- Background: PubMed 24619293Burgerhart JS, Schotborgh CA, Schoon EJ, Smulders JF, van de Meeberg PC, Siersema PD, Smout AJ. Effect of sleeve gastrectomy on gastroesophageal reflux. Obes Surg. 2014 Sep;24(9):1436-41. doi: 10.1007/s11695-014-1222-1.
- Background: PubMed 26341463Oor JE, Roks DJ, Unlu C, Hazebroek EJ. Laparoscopic sleeve gastrectomy and gastroesophageal reflux disease: a systematic review and meta-analysis. Am J Surg. 2016 Jan;211(1):250-67. doi: 10.1016/j.amjsurg.2015.05.031. Epub 2015 Aug 14.
- Individual participant dataSharing planned: Yes. Research projects will be submitted to host (currently JHU) and accepted project will be granted access to read only de-identified database.
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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.
Marcia I Canto, MD principal investigator
Johns Hopkins University
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 GERD and Obesity, run by Johns Hopkins University 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 5 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 21 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 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?
This study is still under way. Results are not available in the source record yet.
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?
Percentage of participants with GERD based on symptoms, and abnormal acid exposure time and/or reflux esophagitis (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03705416, which also lists 11 linked publications.
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 21 Aug 2026.