NCT06473831

Who might be able to join this trial:

• You are between 18 and 65 years old at the time of signing the consent form
• Your Body Mass Index (BMI) is between 30 and 50 (a measure of weight relative to height)
• You have Type 2 diabetes (with a blood sugar marker called HbA1c of 6.5% or higher) and had weight-loss stomach surgery (sleeve gastrectomy) at least 12 months ago; OR you have Type 2 diabetes and have never had that surgery and are not planning to have it at the same time as this study procedure; OR you have regained weight after having sleeve gastrectomy surgery at least 12 months ago
• You agree not to have any other weight-loss or body-reshaping surgery during the study period
• You have been fully informed about the study, agree to follow all its requirements including check-up visits and any required medications, and have signed a consent form
• You have been assessed by a medical team as a suitable candidate for a specific bowel-connection procedure (duodenal ileal anastomosis) and have completed all the standard pre-surgery evaluations required by the trial site

Who may not be able to join:

• You have Type 1 diabetes
• You currently use insulin injections
• Your Type 2 diabetes is not well controlled (confirm with trial site)
• The surgeon plans to perform sleeve gastrectomy surgery at the same time as the study procedure
• You have uncontrolled high blood pressure, high cholesterol, or sleep apnea
• You have had previous surgery on your intestines, colon, or the first part of your small intestine (duodenum), other than weight-loss surgery
• You have had previous surgery, injury, implants, or a medical condition affecting your anatomy in a way that would make the study procedure unsafe or impossible
• You have severe acid reflux disease that cannot be controlled
• You have a condition called Barrett's disease (a change in the lining of the food pipe)
• You have a stomach infection caused by the bacteria Helicobacter pylori or you have active stomach ulcers
• You have a large hiatal hernia (where part of the stomach pushes up into the chest)
• You have inflammatory bowel disease or a colon condition called diverticulitis
• You have any physical condition that would prevent a camera or tube from being passed through your mouth into your stomach (confirm with trial site)
• You have any condition that would prevent keyhole (laparoscopic) or camera-guided (endoscopic) surgery (confirm with trial site)
• You have an implanted pacemaker or defibrillator (heart devices)
• You have a psychiatric (mental health) condition, except for depression that has been well managed with medication for more than 6 months
• You have a history of substance abuse
• You are pregnant, breastfeeding, or planning to become pregnant during the study; women who could become pregnant must agree to use reliable contraception
• Your doctor or anaesthetist has concerns about your general health or fitness that make this procedure unsafe for you
• You have unhealed ulcers, bleeding, tumours, or other tissue problems at the site where the study device would be placed
• You are likely to need an MRI scan within the first 2 months after the procedure
• You have had or are planning any other surgery or procedure within 30 days before or after the study procedure
• You have had a stroke or mini-stroke (TIA) within the 6 months before signing the consent form
• You need ongoing blood-thinning medication (other than aspirin)
• You have an active infection requiring antibiotics that has not been resolved before the study procedure
• You stopped using tobacco or nicotine products less than 3 months before signing the consent form
• You have a known allergy to any components of the study device (including a material called PGLA) or to contrast dye used in imaging
• You have a serious health condition that means you are unlikely to live for more than 12 months
• You are currently taking part in another clinical trial of an unapproved drug or device that has not yet reached its main results stage
• You have tested positive for COVID-19 before the study procedure, in line with local guidelines
• You have any other medical, physical, social, or psychological condition that, in your doctor's opinion, could affect your ability to take part or complete the study (confirm