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 aged between 22 and 75 years old (male or female)
• People who have experienced at least three episodes of heartburn and/or acid reflux per week over the past three months
• People who have had a specific acid monitoring test (either a wireless "Bravo" test or a tube-based test) in the last 24 months, taken after stopping acid-reducing medication (PPIs) for at least 7 days, showing acid levels above a certain threshold — or, if no such test has been done, people whose doctor has determined they have genuine acid reflux disease (not functional GERD), confirmed in writing by the study's Medical Director (confirm with trial site)
• People who are willing and able to give their consent to take part and to follow all study requirements, including using a smartphone app
• People who agree to allow their GP and any relevant specialist to be told about their participation in the trial

Who may not be able to join:

• People who have previously had surgery on their stomach or food pipe (oesophagus)
• People with an active stomach ulcer or active Helicobacter pylori infection causing symptoms
• People with swollen veins in the oesophagus or stomach, or a narrowing of the oesophagus caused by acid damage
• People with severe difficulty swallowing
• People with a personal history of suspected or confirmed cancer of the oesophagus or stomach
• People who have had any other cancer in the past 2 years
• Women who are pregnant or planning to become pregnant during the trial
• People with poorly controlled diabetes (confirm with trial site for specific measurement threshold)
• People with serious heart conditions such as irregular heartbeat, reduced blood supply to the heart, or who have a pacemaker or defibrillator
• People who have any other implanted electrical device in their body (such as a brain or nerve stimulator)
• People with a known allergy to the adhesives or patches used in the study device
• People with severe lung disease
• People with a history of serious conditions affecting multiple organs, such as kidney failure or liver failure
• People with a known autoimmune or connective tissue disorder (such as scleroderma or Sjögren's Syndrome) that has required treatment in the past 2 years
• People with a history of Barrett's oesophagus (a condition affecting the lining of the food pipe)
• People with a type of hiatal hernia where part of the stomach sits beside the food pipe (para-oesophageal hernia)
• People with a known sliding hiatal hernia of 4 cm or more in the past 3 years
• People with a history of severe oesophageal inflammation (Grade C or D, known as erosive oesophagitis) in the past 5 years
• People with a Body Mass Index (BMI) above 32
• People with a history of gastroparesis (a condition where the stomach empties too slowly)
• People with a history of fibromyalgia, epilepsy, or endometriosis
• People with an umbilical (belly button) hernia larger than 3 cm
• People who have previously used the device being studied in this trial
• People who are currently taking part in any other interventional clinical trial
• People who are unable to sign the informed consent form
• People who are unable to understand and complete the study reports and questionnaires
• People who are unable to follow the study requirements
• People whose medical conditions or medications, in the opinion of the lead doctor, could affect their safety or the quality of the study data

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