Capsule Endoscopy for Bariatric Surgery Candidates

(NAVICAM Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jerry Dang

Disqualifiers: Pacemakers, Dysphagia, Gastrointestinal symptoms, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for examining the upper digestive tract in individuals preparing for weight loss surgery. Instead of the usual endoscopy, which requires sedation, participants will swallow a small camera capsule that doctors control with magnets from outside the body. Known as Magnetically Controlled Capsule Endoscopy, this method aims to determine its safety and effectiveness for individuals with a body mass index (BMI) over 38. The trial seeks participants planning to undergo bariatric surgery who meet specific health conditions related to obesity. This approach could offer a less invasive option for those needing an internal stomach check before surgery.

As an unphased trial, the study provides a unique opportunity to explore a potentially safer and more comfortable diagnostic method before surgery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this capsule endoscopy device is safe for bariatric surgery candidates?

Research has shown that the magnetically controlled capsule endoscopy (MCCE) system is safe for people. In one study, researchers reported no harmful effects, demonstrating the safety and feasibility of guiding the capsule with a handheld magnet inside the stomach of healthy volunteers. Another study found that MCCE performs as well as traditional methods in detecting stomach problems. Importantly, the capsule does not require sedation, offering a gentler option for patients. Overall, evidence supports that the MCCE device provides a safe and effective way to examine the stomach without major risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about magnetically controlled capsule endoscopy (MCCE) for bariatric surgery candidates because it offers a non-invasive, patient-friendly alternative to traditional endoscopic evaluations. Unlike the standard of care, which often involves endoscopy with sedation, MCCE allows patients to simply swallow a capsule that captures detailed images as it moves through the gastrointestinal tract. This method not only reduces discomfort and the need for sedation but also provides precise control over the capsule's movement using an external magnetic system, enabling thorough and accurate examination. This innovative approach could streamline preoperative assessments and improve patient experiences.

What evidence suggests that this capsule endoscopy is effective for examining the upper digestive tract in bariatric surgery candidates?

Research has shown that magnetically controlled capsule endoscopy (MCCE), the treatment under study in this trial, offers a promising way to examine the stomach. In one study with 40 patients, this technology successfully viewed key parts of the stomach over 95% of the time. Another study found that MCCE could safely examine the esophagus in healthy volunteers. This method allows for a complete stomach check in about 20 minutes without sedation. Additionally, capsule endoscopy is considered safer for staff because it produces less aerosol than regular endoscopy. The FDA has approved the system, highlighting its reliability for viewing the stomach. ^{2 3 4 5 6}

Who Is on the Research Team?

Jerry Dang, MD, PhD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for adults (18+) with severe obesity (BMI over 38 but no more than 65) who are planning to have their first weight loss surgery and have a waist size of 77 inches or less.

Inclusion Criteria

I am 18 years old or older.

I am having my first weight loss surgery as recommended by guidelines.

I have been diagnosed with morbid obesity.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Evaluation

Participants undergo preoperative upper gastrointestinal tract evaluation using the NaviCam® Xpress™ Stomach System

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

2-3 weeks

1 follow-up call

What Are the Treatments Tested in This Trial?

Interventions

• Magnetically Controlled Capsule Endoscopy

Trial Overview

The study tests a swallowable camera capsule, controlled by magnets from outside the body, to examine the upper digestive tract before bariatric surgery. It aims to see if this method is safe and effective compared to traditional endoscopy.

How Is the Trial Designed?

Group I: Magnetically Controlled Capsule Endoscopy (MCCE) Arm Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Jerry Dang

Lead Sponsor

Trials

1

Recruited

160+

The Cleveland Clinic

Collaborator

Trials

1,072

Recruited

1,377,000+

AnX Robotica Corp.

Industry Sponsor

Trials

1

Recruited

30+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07587437?lastUpdPost=2020-10-10_

Preoperative Use of a Magnetically Controlled Capsule ...

This study could help determine if the camera capsule is a good alternative to traditional endoscopy for people preparing for weight loss ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8739542/

Development and Application of Magnetically Controlled ...

The results showed that it was safe and feasible to use the handheld MCCE to examine the esophagus of healthy volunteers, but it may require greater magnetic ...

3.

anxrobotics.com

anxrobotics.com/products/navicam-xpress-stomach-capsule-system/

NaviCam® Xpress™ Stomach System

Redefining Stomach Visualization with Magnetic Precision. Non-sedated. Real-time. Complete gastric assessment in just 20 minutes.

4.

withpower.com

withpower.com/trial/phase-diabetes-7-2025-7a1cb

Capsule Endoscopy for Bariatric Surgery Candidates · Info ...

The study tests a swallowable camera capsule, controlled by magnets from outside the body, to examine the upper digestive tract before bariatric ...

5.

igiejournal.org

igiejournal.org/article/S2949-7086(23)00052-3/fulltext

Magnetically controlled capsule for assessment of the ...

In this study of 40 patients, MCCE detected each of the 6 preidentified major gastric anatomic landmarks with a greater than 95% rate of visualization.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07587437?aggFilters=status%3A

Preoperative Use of a Magnetically Controlled Capsule ...

The goal of this clinical trial is to test if a swallowable camera capsule can safely examine the upper digestive tract in people preparing ...