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Clinical trial of new magnetically controlled capsule endoscope, NaviCam, underway

By Susan E.W. Spencer

UMass Medical School Communications

January 08, 2021

David R. Cave, MD, PhD, professor of medicine and director of clinical gastroenterology research, has launched a clinical trial of a new magnetically controlled capsule endoscope that may provide an alternative to conventional upper endoscopy without the need for anesthesia.

David R. Cave, MD, PhD

The first-of-its-kind NaviCam MCCE System, made by AnX Robotica Corp., could “democratize endoscopy,” said Dr. Cave.

The video capsule is initially attached to a very thin tether to allow for optimal imaging of the esophagus, comparable to that of conventional endoscopy. It is then released, and under magnetic control, can examine the entire lining of the stomach. The camera in the capsule can take and transmit still images and video to the control consol. Capsule endoscopy produces almost no aerosol formation, compared with regular endoscopy, so is safer for staff doing the procedure, a big issue in the COVID-19 era.

The NaviCam System installed at UMass Memorial Medical Center in November is the first to operate in the United States, although it has been used extensively in China, after being developed in Silicon Valley. A second system is being installed in the emergency department at George Washington University Hospital in Washington, D.C.

Cave said he is training staff on models of the stomach and, with the help of volunteers, will enroll 75 patients with upper abdominal symptoms such as heartburn, upper abdominal pain and nausea into the study.

Patients will act as their own controls. In other words, they will have the magnetic capsule with NaviCam and then either the same day or in the next few days, they will have a regular endoscopy. A blinded third party will read both sets of images to see how they compare. This trial will also allow researchers to optimize conditions for examination of the esophagus and stomach, particularly to find out how much water the patient needs to swallow to distend the stomach to get optimal images.

Cave said that in the U.S. there are many patients with nonulcer dyspepsia, a functional disorder, patients who have pain, bloating, nausea, vomiting and reflux-like symptoms but without diagnostic findings on conventional endoscopy. These are the patients he would like to save having regular endoscopy and limit upper endoscopy to those that need biopsy or endoscopic treatment.

In the long run, he hopes that this device will allow a quick, reliable way of examining the esophagus and stomach that can be done in the office setting without sedation, thus sparing most patients the need to have conventional endoscopy. Conventional endoscopy requires sedation, so the patient must take a day out of work. It is a common procedure, but with a low diagnostic yield, he said. Eventually he would like to extend the use of this device to screening for other upper GI conditions.

The NaviCam System is installed in more than 1,000 locations around the world and has been used with more than 500,000 patients, according to AnX Robotica Corp. Numerous studies have been completed in peer-reviewed publications. Additional clinical trials are ongoing in the U.S., Europe and Asia.