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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Jerry Dang
Study ID
NCT07587437
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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 Dates

Start date
Aug 1, 2025
Status verified
May 2026
Primary completion
Dec 30, 2026
Completion
Jan 30, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Magnetically Controlled Capsule Endoscopy (MCCE) Arm
    Participants will undergo preoperative upper gastrointestinal tract evaluation using the NaviCam® Xpress™ Stomach System, a magnetically controlled capsule endoscopy device. After fasting overnight, participants will swallow the capsule with 500ml of water. The capsule will initially be tethered and will capture images as it descends the esophagus. Once positioned appropriately, the tether will be released via 15ml air injection, and the surgeon will control the capsule's movement in the stomach using an external magnetic control system. All participants will be followed for 14-21 days post-procedure.

Primary Outcome Measure

Number of Participants with Successful Magnetic Control of the Capsule [ Time Frame: From enrollment to the end of interpretation of the MCCE images, approximately 20 days. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland Clinic FoundationClevelandOhio44195-

Find similar trials in Cleveland, OH

By condition
Hypertension (high blood pressure)Obesity / overweight
By specialty
CardiologyHeart diseaseEndocrinologyMetabolic healthWeight loss
By research site
Cleveland Clinic Foundation· Cleveland, OH

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