Jerry Dang
The goal of this clinical trial is to test if a swallowable camera capsule can safely examine the upper digestive tract in people preparing for weight loss surgery. The camera capsule (called NaviCam® Xpress™ Stomach System) is controlled by magnets from outside the body and doesn't require sedation, unlike traditional endoscopy. The main questions it aims to answer are: Can the camera capsule be safely used in people with a body mass index (BMI) greater than 38? Can doctors successfully control and move the camera capsule to see the necessary areas of the stomach and esophagus? Researchers will evaluate 30 participants who are preparing for weight loss surgery. Participants will: Swallow the camera capsule with water after not eating or drinking since midnight Have their upper digestive tract examined while the doctor controls the capsule from outside their body Complete a brief satisfaction survey about their experience Be followed up with a phone call 2-3 weeks after the procedure This study could help determine if the camera capsule is a good alternative to traditional endoscopy for people preparing for weight loss surgery, potentially avoiding the need for sedation.
Detailed Description: The NaviCam® Xpress™ Stomach System represents a novel approach to upper gastrointestinal visualization in the bariatric surgery population. This magnetically controlled capsule endoscopy (MCCE) system consists of a single-use wireless capsule that contains imaging components and magnetic materials that allow external control through a physician-operated magnet. Technical Specifications and Procedure: The capsule is equipped with cameras capable of capturing both still images and continuous video footage. After the patient swallows the capsule with 500ml of water, it i…
Inclusion Criteria: * Age ≥ 18 years old * Diagnosed with morbid obesity * Undergoing primary bariatric surgery by current international guidelines * BMI greater than 38 kg/m² and less than or equal to 65 kg/m² * Waist circumference less than or equal to 77 inches Exclusion Criteria: * Patients with permanent pacemakers and other surgically placed metallic devices which function can interfere with the magnetic field * Patients with dysphagia and those who are at risk of capsule retention (gastric outlet obstruction, intestinal stenosis, inflammatory bowel disease, previous abdominal surgeri…
The intervention consists of a wireless capsule containing cameras and magnetic materials that enable external control. After overnight fasting, participants swallow the capsule with 500ml of water. The capsule is initially tethered and captures images as it descends the esophagus. Once appropriately positioned, the tether is released by injecting 15ml of air. A trained surgeon then controls the capsule's movement within the stomach using an external magnetic control system, allowing systematic visualization of the upper gastrointestinal tract mucosa. The procedure is performed without sedation and takes place at the Main Campus M60 facility. The capsule naturally passes through the digestive system after the examination.