The SmartPill Capsule System sends data measurements from a patient’s GI tract to a mobile receiver.

The New York State Office of Science, Technology, and Academic Research (NYSTAR) has awarded a Technology Transfer Incentive Program (TTIP) contract that provides as much as $500,000 in funding for 510(k) FDA Approval Phase II clinical trials of the SmartPill capsule system.

The TTIP contract was awarded to the Research Foundation of State University of New York, a nonprofit, educational corporation acting on behalf of the University at Buffalo, the State University of New York (UB).

“NYSTAR is funding a project that enables us to advance our study of noninvasive methods of diagnosing and treating GI disorders and diseases,” says principal investigator Jeffrey M. Lackner, PsyD, assistant professor, UB Department of Medicine, School of Medicine and Biomedical Sciences. “This work is cutting-edge research that not only stands to increase the efficacy of diagnostic testing but also reduce the cost and discomfort of conventional assessment modalities.”

SmartPill Diagnostics recently selected Cognigen Corp (Amherst, NY) to provide clinical research organization services to the phase II clinical trials. In this role, Cognigen will be responsible for such tasks as managing, validating, analyzing test trial data, and generating the clinical monitoring report that will support and facilitate SmartPill Diagnostics’ application to the FDA for 510(k) approval.

Recently, SonoSite took part in a 10-day underwater experiment with NASA Extreme Environment Mission Operations (NEEMO) 7 to demonstrate and evaluate a variety of medical diagnostic and therapeutic technologies to enhance the delivery of medical care in remote and harsh environments. The experiment, which also involved the Canadian Space Agency and the Centre for Minimal Access Surgery at McMaster University of Hamilton, Ontario, took place off the coast of Key Largo, Fla, 19 m below the surface of the sea in an underwater habitat called Aquarius. The extreme hostile environment of this location is analogous to human space flight and has been used by NASA in the training of space station astronauts since 2001. The five aquanauts who took part in the experiment used SonoSite’s TITAN compact ultrasound system to scan one another in simulated emergency situations and transmit live images to St Joseph’s Healthcare in Hamilton, Ontario for real-time review by radiologists.

“There are two significant parts to the NEEMO 7 mission: telementoring and telerobotics,” says Drew D’Aguilar, general manager of SonoSite. “Telementoring consists of an experienced physician located at a remote site using two-way telecommunication to guide someone who is less experienced through certain health care procedures and even surgery.”

According to D’Aguilar, the system is ideal for identifying certain aspects of trauma, such as a ruptured spleen. Using the system, a medical professional can help guide a member of a space mission to look for fluid in the abdomen of an injured team member in order to demonstrate the ruptured spleen.

“Telerobotics involves using virtual reality technology to translate a surgeon’s hand movements into the movements of a robot in the Aquarius habitat,” D’Aguilar adds.”

“The TITAN ultrasound system was chosen for this experiment because of its small size, imaging capabilities, ease of use, and its ruggedness,” says Juliana Dobranowski, MD, chief of diagnostic imaging at St Joseph’s.

With the help of the TITAN technology, the 10-day mission went flawlessly.

“We weren’t sure how the system was going to respond to the three different atmospheres and the intense humidity, but it worked extremely well,” says George Noisworthy of SonoSite. “It behaved just like it would in a normal environment, and that was crucial for us.”

According to D’Aguilar, the next step in the process is to decide whether this technology will be a permanent fixture in future space missions. “Ultrasound is the lightest, smallest, easiest to deal with,” says D’Aguilar. “Ultrasound in a space-type environment, if it can do the job, is the diagnostic imaging modality of choice. You’ve got people up in a hostile environment, and if something goes wrong, you want to be able to diagnosis and treat it.”

While the TITAN ultrasound system has less than half a percent failure rate, according to SonoSite, those on the ground should not rule out the opportunities this experiment provides for other diagnostic equipment to be used on long-term missions in space. With these missions, and their respective equipment, will come the need for this equipment to be serviced. The NEEMO 7 mission used telerobotics to perform emergency procedures on remote crew members. In the future, this same technology may be used to perform emergency procedures on remote medical equipment.

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