Motus GI Holdings, Inc. announced that the Boston Medical Center (BMC) has initiated the EXPEDITE clinical study to evaluate the effectiveness of the Pure-Vu System on bowel preparation rates.
“There is a great need for a solution like the Pure-Vu System that helps care providers overcome challenges with conventional bowel preparation regimens. One of the key things we will look at in this study is how effectively this system can accelerate time to colonoscopy and diagnosis for high-risk inpatient cases, such as GI bleeds. This will include performing same-day colonoscopy with no preparation in critical inpatient populations,” said Brian C. Jacobson, MD, associate professor of medicine, Boston University School of Medicine, Section of Gastroenterology, Boston Medical Center. “The EXPEDITE study will also evaluate how the Pure-Vu System can help address the impact of inadequate preparation on outpatient cases performed in the hospital. Inadequate bowel preparation often leads to cancellation and rescheduling of outpatient cases. Despite the patient support system we have in place at our hospital, many patients that have outpatient procedures canceled due to inadequate preparation fail to have an adequate colonoscopy within the next six months. We need solutions to make sure these patients don’t lose the benefits of diagnostic colonoscopy due to challenges with conventional bowel preparation.”
Tim Moran, chief executive officer of Motus GI, commented, “We are excited to be part of this investigator-initiated study with a leading team of gastroenterologists at BMC to gather further insights on the benefits of the Pure-Vu System for inpatient and outpatient colonoscopies. BMC has initiated this study because insufficient bowel prep rates continue to be a burden on patients and the healthcare system, leading to longer hospital stays, delayed diagnosis, and additional costs to the patient and hospital. In multiple clinical trials involving challenging inpatient and outpatient cases, the Pure-Vu System has consistently helped achieve adequate bowel cleanliness rates greater than 95% following a reduced prep regimen. We believe expanding clinical and commercial experience will further demonstrate the Pure-Vu System’s capability to help physicians address insufficient bowel prep and reduce inefficiencies, delays, procedure cancellations and repeat procedures.”
The EXPEDITE study will enroll up to 50 inpatients and 50 outpatients over a 12-month study period. The study will evaluate bowel preparation adequacy in the 100 patients undergoing a colonoscopy with the Pure-Vu System against inpatient and outpatient populations that had a colonoscopy over the prior 24 months preceding availability of the Pure-Vu System. The rate of bowel preparation adequacy will be measured before and after Pure-Vu System using the Boston Bowel Preparation Scale (BBPS), a validated assessment instrument that is used broadly by gastroenterologists on a scale of 0 to 3 per segment, requiring a minimum score of 2 to be considered adequately prepped. The BBPS scale has been used in all Pure-Vu System clinical studies performed to date including the REDUCE inpatient colonoscopy study for which results were presented at Digestive Disease Week in May 2019. Findings from the REDUCE study, showed per segment BBPS improved from an average baseline of 1.74, 1.74 and 1.5 to 2.89, 2.91 and 2.86, respectively, with a statistically significant p value of .001 for all three segments of the colon after Pure-Vu System use.