NCT03705416Active, not recruiting
Long Term Outcomes of Bariatric Patients Treated With Surgery or Endoscopy
Reflux in the Obese Undergoing Surgery or Endoscopy (ROSE) Previously: Gastroesophageal Reflux Disease (GERD) in Bariatric Patients
Source: ClinicalTrials.gov · Last updated 21 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 250 (estimated)
- First submitted
- 21 Sept 2018
- Start date
- 30 Mar 2019
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Johns Hopkins University
- Diseases
- Obesity
- NCT number
- NCT03705416
What you commit to
- Study type: Observational
- Planned participants: 250
- From 30 Mar 2019 to the primary completion date, 31 Dec 2026
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients treated with intragastric balloons.
- Prior bariatric treatment procedure
- Prior surgical or endoscopic anti-reflux procedure
Other illness
- Esophageal, gastric or duodenal malignancy
- Known portal hypertension, visible esophageal or gastric varices, or history of esophageal varices
Lab values
- 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
Other
- Any patient with BMI \< 30 Kg/m2
- Pre-existing esophageal stenosis/stricture preventing advancement of an endoscope during screening/baseline Esophagogastroduodenoscopy (EGD)
- Severe medical comorbidities precluding endoscopy, or limiting life expectancy to less than 2 years in the judgment of the endoscopist
- Active fungal esophagitis
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins University Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Memorial Hermann Health System Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Northwell Health Coordinator of this site? Confirm its status | New Hyde Park | United States | Unknown status |
| Weill Cornell Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Legacy Oregon Clinic Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Utah-Health: University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.