Clinical trial

Preoperative Use of a Magnetically Controlled Capsule Endoscopy in Patients Undergoing Bariatric Surgery

Invitation only · Not applicable · 1 countries · Registry ID NCT07587437

Invitation onlyNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionObesity, Bariatric Surgery Candidate, Hypertension, Diabetes

Full registry criteria

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 surgeries with suspicious of adhesive bowel disease) * Patients with reported upper gastrointestinal symptoms who would require a conventional EGD * Patients currently participating in other clinical studies * Patients who do not speak English

Treatments and study arms

Magnetically Controlled Capsule Endoscopy (MCCE)

Device

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.

Primary outcomes

Number of Participants with Successful Magnetic Control of the CapsuleFrom enrollment to the end of interpretation of the MCCE images, approximately 20 days.

Successful magnetic control is defined as the ability of the NaviCam Xpress Stomach System to be moved as intended and controlled by the surgeon to all target anatomical regions. Reported as the number of participants in whom successful magnetic control was achieved.

Number of Participants with Adequate Visualization of the Esophageal and Gastric MucosaFrom enrollment to the end of interpretation of the MCCE images, approximately 20 days.

Adequate visualization is defined as the NaviCam Xpress Stomach System providing satisfactory imaging of the esophageal and gastric mucosa as assessed by the operating surgeon. Reported as the number of participants in whom adequate visualization was achieved.

Number of Participants Completing MCCE Without Conversion to Conventional EndoscopyFrom enrollment to the end of interpretation of the MCCE images, approximately 20 days.

Defined as successful completion of the magnetically controlled capsule endoscopy procedure without the need for conversion to a conventional esophagogastroduodenoscopy (EGD). Reported as the number of participants who completed the procedure without conversion.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Cleveland Clinic Foundation🇺🇸 Cleveland, Ohio, United States

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