The Pure-Vu System was safe and effective in cleaning poorly prepared colons during colonoscopies, according to research published in Endoscopy.
In a press release issued by the device’s manufacturer, Motus GI, Peter D. Siersema, MD, PhD, of the department of gastroenterology and hepatology at Radboud University Medical Center in the Netherlands, said the study’s findings show that Pure-Vu could reduce dependency on purgative bowel preps.
“The ability to offer a solution to difficult-to-prep populations fills an important unmet need in colonoscopy,” he said. “The data from this study suggest that Pure-Vu could be an important tool for inpatients as well as high medical need outpatient, especially for those that have difficulty with the preparation regimes such as elderly patients, diabetics and patients with motility issues.”
Researchers studied the device’s feasibility in 47 patients (46.6% male; median age, 61 years) referred for colonoscopy. Endoscopists used the Pure-Vu system to cleanse patients’ colons during the procedure after they underwent a limited preprocedure bowel cleansing regimen. The study’s primary outcome was the proportion of adequately prepared patients before and after segmental washing with the device based on a Boston Bowel Preparation scale score of at least 2. Researchers also assessed cecal intubation rate and procedure time, as well as usability and patient satisfaction.
Researchers found that the Pure-Vu System helped improve both the proportion of patients who had adequate bowel cleansing (19.1% vs. 97.9%; P < .001) and median BBPS score (3, interquartile range 0–5; to 9, IQR 8–9).
The median cecal intubation time was 16.5 minutes (IQR, 9–28.3), and the median procedure time was 34 minutes (IQR, 25–42.8). Additionally, physicians reported being satisfied with the device’s ease of use, and it was well-tolerated by patients.
The FDA cleared the Pure-Vu System last year, and Motus GI is currently concentrating on post-approval clinical trials ahead of the device’s expected full commercial launch later this year.
“The data bolsters our confidence in the Pure-Vu System’s ability to successfully cleanse the colon to a high level regardless of the adequacy of the pre-procedural prep,” Tim Moran, CEO of Motus GI, said in the press release. “We continue to generate clinical and health economic data that we believe will help drive Pure-Vu to be the standard of care in the inpatient market and support high need segments in the outpatient market, where patients present with an inadequately prepped colon up to 23% of the time.” – by Alex Young
Disclosures: The study was sponsored by Motus GI. Moran is employed by Motus GI.