California-based bioelectronic medicine company Boomerang Medical has announced its enrolment milestone in its pilot study investigating a breakthrough device intended to treat inflammatory bowel disease (IBD)
The BOOM-IBD clinical trial (NCT05414955) will be the first of its kind, prospective, multicentre study carried out in the US examining the use of devices designed to read electrical activity within the body in a bid to treat IBD. The aim of the technology is to stimulate the parasympathetic nervous system to decrease the stress on the body and reduce inflammation.
Boomerang Medical has been able to successfully enrol patients with Crohn’s disease and ulcerative colitis, the two most common forms of IBD, at multiple trial sites across the country.
Boomerang Medical’s technology received breakthrough designation by the US Food and Drug Administration (FDA) in March of this year.
The trial is set to be carried out at clinical sites across the us including Mount Sinai, Columbia Irving Medical Center, and the University of Pennsylvania. The trial was designed by the Comprehensive Digestive Institute of Nevada, who have enrolled the last patient in the study.
Dr. Christian Stone, principal investigator at the Comprehensive Digestive Institute of Nevada, said: “This study represents a promising step forward in the quest for expanding the armamentarium for managing IBD. Our participation underscores our dedication to advancing patient care, and we are eager to contribute valuable insights that could advance the future management of IBD.”
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According to GlobalData’s Clinical Trials Enrollment Database, enrolment rates in IBD trials have been consistently low in the last 10 years, with 2021 and 2022 being the worst years in recent memory.
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