Gastro-oesophageal Reflux Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are between 18 and 65 years old, of any gender
• People with a body mass index (BMI) between 35 and 55 (a measure of body weight relative to height)
• People whose BMI falls within that range both before and after completing 6 months of non-surgical weight management attempts
• People who have acid reflux disease (GERD), confirmed by a specific pH monitoring test called the Bravo pH test, showing that stomach acid is entering the food pipe more than a certain amount
• People who have health insurance that covers the costs of weight-loss surgery and related medical care before and after the procedure
• Women who could become pregnant must be using suitable contraception throughout the study and must have a negative pregnancy test at the start of the study and before surgery
• People who are able to read and sign a consent form agreeing to take part

Who may not be able to join:

• People who have a hiatal hernia (where part of the stomach pushes up through the diaphragm) larger than 2 cm
• People who have a significant problem with how the muscles of the food pipe move food, as assessed by the trial doctor
• People who have severe gastroparesis (a condition where the stomach empties very slowly)
• People who have previously had weight-loss surgery or surgery to treat acid reflux
• People who have Barrett's oesophagus (a condition where the lining of the food pipe is damaged by long-term acid exposure)
• People who would need mesh material used during their procedure
• People with severe heart problems (such as severe heart failure or unstable heart disease) or end-stage lung disease, as determined by the trial doctor
• People who have a pacemaker, implantable defibrillator, or nerve stimulation device
• People who have high blood pressure in the liver's blood vessels (portal hypertension) or liver scarring (cirrhosis)
• People who have chronic pancreatitis (long-term inflammation of the pancreas)
• People currently undergoing cancer treatment
• People who are unable to have general anaesthesia
• People with a serious, uncontrollable blood clotting disorder
• People with severe or uncontrolled inflammatory bowel disease
• People with a severe or uncontrolled psychiatric condition, such as psychosis or bipolar disorder, as identified during the standard pre-surgery mental health assessment
• People who have had thoughts of suicide, or have unstable or untreated major depression, within the past year
• People who have had an alcohol or substance use disorder within the past year
• People who are pregnant, breastfeeding, or planning to become pregnant within the next 24 months
• People who may have difficulty understanding or following the instructions required before and after surgery
• People with any other current or past health condition that, in the trial doctor's opinion, would make weight-loss surgery (sleeve gastrectomy) unsuitable or unsafe for them (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.