Clinical Research Directory
Browse clinical research sites, groups, and studies.
Preoperative Use of a Magnetically Controlled Capsule Endoscopy in Patients Undergoing Bariatric Surgery
Sponsor: Jerry Dang
Summary
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.
Official title: Preoperative Use of a Magnetically Controlled Capsule Endoscopy in Patients Undergoing Bariatric Surgery: A Feasibility Prospective Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2025-08-01
Completion Date
2027-01-30
Last Updated
2026-05-14
Healthy Volunteers
No
Interventions
Magnetically Controlled Capsule Endoscopy (MCCE)
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.
Locations (1)
Cleveland Clinic Foundation
Cleveland, Ohio, United States