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First In Humans Clinical Trial Demonstrates Non-Invasive Expulsion of Kidney Stones

Press Release From: National Space Biomedical Research Institute (NSBRI)
Posted: Tuesday, May 19, 2015

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The National Space Biomedical Research Institute (NSBRI) announced that Dr. Jonathan Harper will present the findings of an FDA-registered "first in humans" trial to non-surgically propel and expel kidney stones from the body, during today's plenary session at the 2015 American Urological Association (AUA) annual meeting in New Orleans.

Dr. Harper and his colleagues in the Department of Urology and Applied Physics Laboratory at the University of Washington have invented a new way to facilitate kidney stone passage or dislodge large obstructing stones, using ultrasound. With one probe placed on the patient's skin, a physician can target the stone on the system's ultrasound image. The system focuses ultrasound waves on the stone, which makes the stone "hop" to a new location. Importantly, ultrasound technology does not expose patients to x-rays or other forms of ionizing radiation. Fifteen volunteers with various body sizes presenting with stones of as large as 14 mm and from all regions of the kidney were included in the clinical trial. Kidney stones were moved in all but one subject.

Dr. Jonathan Harper said, "I am excited about presenting our findings at this year's AUA annual meeting. Not only does our ultrasound technology safely move and expel kidney stones, but also it is performed in the clinic setting without pain. The impact of this technology on the US healthcare system is substantial because more Americans experience nephrolithiasis, or kidney stone disease, than develop diabetes or heart disease. Kidney stones cause severe pain, obstruction of the urinary tract, and loss of worker productivity. The use of ultrasound technology to move kidney stones is a major advance with broad clinical utility for people on Earth."

This clinical trial has been advanced with funding from NSBRI, as a project within the portfolio of the Institute'sSmart Medical Systems and Technology (SMST) Team. The goal of the SMST Team is to develop intelligent, integrated medical systems to deliver quality health care during spaceflight and exploration. New technologies developed by this team also deliver immediate benefits for medical care on Earth.

"During space flight, microgravity, dehydration, and altered bone metabolism collectively increase the likelihood of an astronaut developing a kidney stone," said Jeffrey P. Sutton, M.D., Ph.D. - NSBRI's President, CEO and Institute Director. Kidney stones have been observed in U.S. astronauts before and after spaceflight and one Russian cosmonaut reported abdominal pain on orbit which was suspected to be due to a kidney stone; however, the pain resolved within a few days. Non-invasive approaches to move and ultimately expel kidney stones from the body provide medical capabilities needed by NASA and other international space agencies. If stones can be moved and then passed while they are relatively small, downstream complications such as infection and sepsis that could end space missions may be avoided.

Ultrasound technologies have been successfully used for many years on the International Space Station (ISS), primarily to perform imaging of the astronauts' eyes, bones, and internal organs. The successful outcome of this clinical trial mitigates the risk of renal stone formation, as identified on NASA's Human Research Roadmap, and augments existing ISS ultrasound techniques and protocols. Technologies and countermeasures are tested on the ISS as a forerunner to deployment on future exploration mission to Mars or other deep space destinations. Since astronauts on long-duration, deep space missions will be unable to return quickly to Earth, new methods of remote medical diagnosis, monitoring and treatment are necessary. On exploration missions, it is also possible that medical procedures may be performed by a non-physician astronaut, and therefore techniques to deal with medical emergencies, such as kidney stones, must be simple to administer, robust, and highly effective.  

About NSBRI

Established in 1997 through a NASA competition, NSBRI is headquartered at Baylor College of Medicine, in the Texas Medical Center and is a consortium of twelve leading biomedical institutions. NSBRI, a 501(c) (3) organization partnered with NASA, is studying the health risks related to long-duration spaceflight and developing the technologies and countermeasures needed for human space exploration missions. The Institute's science, technology and career development projects take place at approximately 60 institutions across the United States. For more information, please visit www.nsbri.org. The Industry Forum engages the private sector to develop medical products for both space and Earth through commercialization activities and seed funding. Find out more at www.NSBRIforum.org and follow the NSBRI Industry Forum on Twitter and Facebook.

About UW Medicine

UW Medicine╩╝s mission is to improve the health of the public by advancing medical knowledge, providing patient care, and training the next generation of health professionals. Our system includes Harborview Medical Center, Northwest Hospital & Medical Center, Valley Medical Center, UW Medical Center, UW Neighborhood Clinics, UW Physicians, UW School of Medicine and Airlift Northwest.

For more information on the AUA annual meeting and to see a full schedule, visit www.aua2015.org.

 

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