Obesity Trial, Recruiting

Written by an AI model from the 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 with a BMI of 30 or higher who have regained at least 25% of the weight they originally lost after sleeve gastrectomy surgery (where that surgery was initially considered successful)
• People who had their sleeve gastrectomy surgery at least three years before joining the trial
• People between the ages of 22 and 60
• People who agree not to use any prescription or over-the-counter weight loss medications or supplements during the study — including injections such as Ozempic, Wegovy, Mounjaro, or similar products
• Women who could become pregnant must agree to use an accepted form of contraception during the study
• People who agree not to donate blood while taking part in the study
• People who are able to follow the study requirements and sign a consent form confirming they understand what is involved
• People whose weight has been stable (changing less than 5%) for at least three months before their first screening appointment
• People who have tried to lose weight through diet and lifestyle changes in the past without lasting success
• People who have reliable access to wi-fi or internet throughout the study
• People who are willing to follow strict long-term dietary changes that the procedure requires

Who may not be able to join:

• People whose sleeve gastrectomy did not produce an adequate initial result (confirm with trial site)
• People who currently need insulin injections to manage their blood sugar
• People whose blood sugar control measure (HbA1c) is above 8.5% (confirm with trial site)
• People who are pregnant, breastfeeding, or planning to become pregnant during the study
• People who are unwilling or unable to complete pain rating scales, questionnaires, or attend required study visits
• People with a history of a serious diabetic complication called diabetic ketoacidosis or hyperosmolar coma
• People who have used any form of insulin for more than one month at any point in their life (except insulin used during pregnancy)
• People who have had a change in their diabetes medication within the last three months
• People using certain types of blood sugar-lowering medications — some specific medication types are permitted, but most are not (confirm with trial site)
• People who have used GLP-1 medications (such as Ozempic or similar) in the last six months
• People with a known autoimmune disease other than a well-managed underactive thyroid — this includes conditions such as coeliac disease, lupus, or scleroderma
• People who have previously had an endoscopic weight-loss procedure, an intra-gastric balloon, or a gastric implant
• People with a history of a stomach-emptying disorder called diabetic gastroparesis
• People with known active hepatitis or active liver disease (other than fatty liver disease)
• People who have had an acute gastrointestinal illness in the seven days before screening
• People with a known history of irritable bowel syndrome, radiation damage to the bowel, Crohn's disease, or other inflammatory bowel conditions
• People with a known history of swallowing problems or structural issues in the oesophagus (food pipe), such as Barrett's oesophagus, narrowing, achalasia, varices, pouches, or reflux that does not respond to medication
• People with a known history of stomach problems such as ulcers, chronic inflammation, stomach varices, a hiatal hernia larger than 3 cm, or stomach cancer
• People with ongoing chronic symptoms related to the stomach, such as persistent upper abdominal pain, nausea, vomiting, or feeling full very quickly after eating
• People currently experiencing recurring symptoms that may suggest a small bowel blockage, such as repeated episodes of abdominal pain, nausea, or vomiting after eating
• People with an active H. pylori stomach infection (people being treated for H. pylori and confirmed as cleared may still be considered — confirm with trial site)
• People with a history of blood clotting problems or upper gastrointestinal bleeding conditions such as ulcers or vascular abnormalities
• People currently taking blood-thinning medication
• People who must take anti-inflammatory medications that cannot be paused for at least four weeks after the procedure
• People who have taken steroid medications by mouth or injection for more than 10 days in a row within the 90 days before screening (inhaled or topical steroids are not included in this restriction)
• People taking medications known to affect how the digestive system moves food through (such as Metoclopramide)
• People currently taking any weight loss medication at the time of screening
• People with an underactive thyroid that is not adequately treated, or who have been on thyroid medication at an unstable dose within the last six weeks
• People with persistent low red blood cell levels (haemoglobin below 10 g/dL)
• People with significant heart disease, including a history of heart valve problems, heart attack, heart failure, mini-stroke, or stroke within the last six months
• People with moderate to severe chronic kidney disease (confirm with trial site for specific test values)
• People with a known weakened immune system — including those who have had an organ transplant, chemotherapy, or radiotherapy within the last 12 months, those with very low white blood cell counts, or those who are HIV positive
• People with an active infection anywhere in the body
• People with a known active cancer diagnosis within the last five years (some treated skin cancers may be exceptions — confirm with trial site)
• People diagnosed with a condition called Multiple Endocrine Neoplasia syndrome type 1
• People who are not considered medically suitable for surgery or general anaesthesia
• People with active illicit substance use or alcohol dependence
• People who currently smoke or have smoked in the last six months
• People who are already taking part in another clinical trial of an investigational drug or device
• People with any other mental or physical condition that the trial doctor considers would make participation unsuitable
• People with other medical conditions that would prevent them from safely having an endoscopic procedure

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