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NCT07587437

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

Enrolling by Invitation
NAAges 18+InterventionalDiagnostic
Jerry Dang
~30 participants
Updated 2026-05-14 on ClinicalTrials.gov
What's tested:Magnetically Controlled Capsule Endoscopy (MCCE)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Successful Magnetic Control of the Capsule
Measured over From enrollment to the end of interpretation of the MCCE images, approximately 20 days.
+2 more outcomes measured

Conditions

Obesity
Bariatric Surgery Candidate
Hypertension
Diabetes

Explore related trials

Bariatric Surgery CandidateObesity

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Jerry Dang, MD, PhD · PRINCIPAL_INVESTIGATOR · The Cleveland Clinic

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • 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.