CHICAGO — Pill cameras used for diagnostic purposes are not new to the U.S. market and there are several companies that make various versions of these pill-sized cameras. But a new company in Israel, Vibrant (Petach Tikva, Israel) has put an interesting spin on the pill-like devices with a vibrating capsule designed to treat, not diagnose, specific types of constipation.
Yishai Ron, MD, director of neurogastroenterology and motility at Tel-Aviv Sourasky Medical Center's Department of Gastroenterology and Hepatology, presented research this week at Digestive Disease Week (DDW) in Chicago that shows promising results for the vibrating capsule.
Tuesday was the last day of this year's DDW, jointly sponsored by the American Gastroenterological Association (AGA; Bethesda, Maryland) Institute, the American Association for the Study of Liver Diseases (AASLD; Alexandria, Virginia), the American Society for Gastrointestinal Endoscopy (ASGE; Downers Grove, Illinois), and the Society for Surgery of the Alimentary Tract (SSAT; Beverly, Massachusetts).
The oral capsule is designed to vibrate as it moves through the digestive tract. The device houses a small engine inside and is programmed to begin vibrating six to eight hours after being swallowed. The vibrations are similar to pacemakers of the large bowel and are intended to cause contractions in the intestine and help move stool through the digestive tract, Ron told Medical Device Daily. He said the ability to program the device any way he sees necessary as a physician and the fact that there are no chemicals or pharmaceuticals in the device at all, is what makes it so promising.
In the pilot study, the vibrating capsule was found to nearly double the weekly bowel movements of patients suffering from chronic idiopathic constipation (CIC) and constipation predominant irritable bowel syndrome (C-IBS).
"Despite the widespread use of medication to treat constipation, nearly 50% of patients are unsatisfied with the treatment either because of side effects, safety concerns about long-term use, or the fact that it simply doesn't work," Ron said.
In the study, 26 patients took the vibrating capsule twice a week and responded to a daily bowel movement and laxative use questionnaire. All patients initially underwent a two-week preliminary period without the use of laxatives. Patients reported an increase in spontaneous bowel movements from two to four times per week, as well as a decrease in constipation symptoms, including reduced difficulty in passing stools and incomplete evacuation. The study also found minimal side effects from the capsule use.
Ron said he was surprised at the efficacy of the Vibrant capsule. "I did not expect it, I thought this was nothing," he said. But after seeing his patients respond so well to the device, he said he is now quite convinced of its potential.
Chronic constipation is a highly prevalent disorder that affects nearly 15% of the U.S. population, according to the researchers. Symptoms can be burdensome, leading to a reduction in patients' quality of life, they noted.
"Sometimes, drug therapies bring more issues than relief for these patients," Ron said. "The results of this study point to the potential for an alternative treatment that avoids the typical drug side effects, such as bloating and electrolyte imbalance, by imitating the body's natural physiology."
Ron said he and his team plan to initiate a controlled, double-blind study to expand on these findings and further explore the capsule's potential.
On the diagnostic side of capsule technology, several companies spotlighted pill cameras on the DDW exhibit floor. Among them, Olympus Medical Systems launched its FDA 510(k) cleared Endocapsule 10 System for small bowel capsule endoscopy procedures.
Olympus said that advances in endoscopic technology, including capsule endoscopy, have helped physicians better detect and treat small bowel disorders at earlier stages. According to Truven Health Analytics (Ann Arbor, Michigan), 137,850 outpatient capsule endoscopies were performed in the U.S. in 2012.
"The new Endocapsule 10 System offers advanced, minimally invasive technology designed to improve diagnostic capabilities, procedural efficiency and patient comfort," said Luke Calcraft, president of the Medical Systems Group at Olympus Corporation of the Americas. "The system can help facilities fulfill the requirements of healthcare reform aimed at improving quality of care, decreasing costs and enhancing patient satisfaction."
The device, which is about the size of a large vitamin or a horse pill, is designed with lens technology and high-resolution image sensor technology, the company said. According to Olympus, the capsule provides 160-degree field of view that sees 10% more mucosa than competing products that feature a 145-degree field of view. The device also offers a 12-hour battery life.
Olympus built software into the capsule system that detects images that require closer inspection by the doctor and indicates where each thumbnail image was captured to determine location of any detected abnormalities. A 3-D tracking function is designed to allow the system to display the capsule position inside the body to check its progress as it moves through the intestine.