Easy to Swallow: Jefferson Digestive Disease Institute Working on a Pair of Pill Capsule Studies
Physicians at Thomas Jefferson University’s Digestive Disease Institute are offering a pair of new pill capsule tests to help better diagnose and treat digestive tract disorders. While diagnosing and treating current patient’s illnesses are the most important aspect of these new capsule-based tests the physicians also hope to advance the technology far enough that one day the possibility of a pill capsule that can photograph and evaluate the function of the entire gastrointestinal tract will be possible.
The first of the two studies is the MiroCam study, being led by David Kastenberg, M.D., associate professor of Medicine in the department of Gastroenterology and Hepatology at Jefferson Medical College of Thomas Jefferson University. This pill capsule has been approved in both Europe and Asia and is now being tested for United States Food and Drug Administration approval in six centers around the country. The key aspect of the study is the battery life of the pill capsule. A standard pill capsule battery lasts about eight hours. Studies show that eight hours is not sufficient enough time for a pill capsule to photograph the whole small bowel in 15 percent of outpatient cases and in one third of inpatient cases. This can put a patient at risk because if the pill capsule battery expires than a patient can be misdiagnosed or not diagnosed at all. The pill capsule being used in this study lasts up to 12 hours, a significant step in the overall goal of creating a pill capsule that will be able to evaluate the entire gastrointestinal tract.
“This study has several important implications,” said Kastenberg. “Not only are we helping the patients for which the study was designed, those suffering from anemia and undiagnosed gastrointestinal bleeds but we are also pushing the technology within the pill capsule forward. These devices have become an indispensable part of diagnosing all kinds of gastrointestinal problems but are limited by their size. You can only fit so much into a device the size of a multivitamin. But as technology adapts and shrinks we are starting to realize that a pill cam that can be swallowed and photograph the whole digestive tract is a very real possibility. What we are learning from this pill capsule will be contributing in a big way to this eventual ‘whole-gut’ pill capsule.”
This study is still openly enrolling and is looking for a total of 105 patients nationwide.
The second capsule test is being evaulated by Dr. Mitchell Conn, M.D., M.B.A., associate professor of Medicine in the department of Gastroenterology and Hepatology at Jefferson Medical College of Thomas Jefferson University. This is the SmartPill, which is the first capsule-based technology that measures gastrointestinal motility and function. The Smartpill has been approved for evaluation of patients with suspected gastroparesis (delayed gastric emptying) and chronic constipation. Symptoms of gastroparesis include nausea, bloating, heartburn and abdominal pain. Once swallowed this capsule collects a variety of data including pressure, temperature and pH from the digestive tract and wirelessly transmits the information back to a data receiver. This data receiver is returned to the physician and analyzed to determine gastric emptying time and colonic transit time. Not only is the SmartPill the first pill capsule to diagnose functional gastrointestinal disorders but it is less invasive and avoids radiation exposure compared with more traditional diagnostic GI procedures and tests used for these disorders.
“SmartPill technology is exciting because it is the first diagnostic tool that allows us to objectively assess the specific abnormalities individuals with functional gastrointestinal disorders may have,” said Conn. “Identifying and localizing the specific functional disorder in these patients will allow us to better individualize treatment with medication, diet and life style changes. We anticipate that a repeat SmartPill study in these patients will help determine the effects of the patient’s treatment.”
“We are very fortunate to be on the leading-edge of pill cam technology at the Jefferson Digestive Disease Institute,” said Kastenberg. “The studies we are conducting now will significantly advance the field and be instrumental in the development of a whole digestive tract pill capsules in the coming years.”
Media Only Contact:
Richard Cushman
Thomas Jefferson University Hospital
Phone: (215) 955-6300
Published: 7/28/2010