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

Enrolling by invitation · Not applicable

Conditions studied: Obesity, Bariatric Surgery Candidate, Hypertension, Diabetes

In brief

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.

Key facts

Study ID

NCT07587437

Run by

Jerry Dang

People needed

30

Starts

2025-08-01

Expected to finish

2027-01-30

Last updated by the study team

2026-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cleveland Clinic Foundation — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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