Management of Reflux After Sleeve Using Stretta

Stopped early · Not applicable

Conditions studied: GERD, Morbid Obesity

In brief

Gastroesophageal reflux disease (GERD) is a frequently seen entity after sleeve gastrectomy. Management of GERD after sleeve is difficult given limited treatment modalities. Stretta is an endoscopic FDA approved device that improves symptoms of GERD, there is minimal information about its use on patients after sleeve. This registry will attempt to get information regarding the treatment of reflux using Stretta after sleeve gastrectomy.

Key facts

Study ID

NCT02637713

Run by

Montefiore Medical Center

People needed

5

Starts

2016-03-01

Expected to finish

2019-05-01

Last updated by the study team

2024-01-23

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Symptomatic reflux: (heartburn, chest discomfort, asthma/chronic cough, laryngitis, nocturnal aspiration or regurgitation)
• On a PPI with GERD-related symptoms
• On a PPI but like to discontinue them

You may not qualify if…

• Age <18 or > 80
• History of a severe psychiatric disorder: including suicidal ideation, or admission to a psychiatric institution.
• Unable or unwilling to consent for an invasive procedure.
• History of intestinal leak after surgery.
• History of revisional bariatric surgery
• Significant sleeve abnormalities such and twist or large fundus
• Hiatal hernia(>2cm)
• Pregnancy
• Inability to comply with study protocols and procedures
• Esophageal stricture, Eosinophilic Esophagitis or Achalasia
• Prior esophageal surgery or therapy for Barrett's Esophagus
• Grades 3 or 4 esophagitis
• Gastric or esophageal varices
• History of obstruction of the small bowel or inflammatory bowel disease
• Pacemaker or implanted cardiac defibrillator
• Coagulopathy or use of anticoagulants
• ASA classification >3
• Scleroderma or other connective diseases
• Use of immunosuppressive medications.

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Stanford University Medical Center — Stanford, California, United States
• Norwalk Hospital — Norwalk, Connecticut, United States
• Gastroenterology Clinic of Acadiana — Lafayette, Louisiana, United States
• Brigham & Women's Hospital — Boston, Massachusetts, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Duke University Health System — Durham, North Carolina, United States
• University Hospitals Case Medical Center — Cleveland, Ohio, United States
• Cleveland Clinic Health System — Cleveland, Ohio, United States
• Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• Houston Methodist Hospital — Houston, Texas, United States
• Memorial Hermann-Texas Medical Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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