Despite a 24-hour liquid diet and a purgative to clean the bowels to prepare for a colonoscopy, patients are poorly prepped in 20% of the 15 million colonoscopies performed worldwide each year, according to Motus GI CEO Mark Pomeranz.
This can mean that patients need to return for a 2nd visit and doctors can miss cancerous lesions. Some people refuse to get colonoscopies in the 1st place, because the preparation is so unpleasant, which has major consequences for colorectal cancer screening, Pomeranz told MassDevice.com.
“Of all the major cancers, it has the lowest adherence to screening,” he told us. “You only have just over 60% compliance of folks staying up with their cancer screening. One of the, if not the biggest, deterrent for that is the whole arduous prep regime.”
Tirat Carmel, Israel-based Motus GI says its Pure-Vu cleansing can significantly increase the number patients with adequately cleansed colons for colonoscopy, according to new clinical trial data. The device is integrated directly with a standard colonoscope to preform intra-procedural cleaning of poorly prepared colons.
In a clinical trial, researchers evaluated the Pure-Vu device in 50 colonoscopies, using a regimen of an 18-24 hour liquid diet and bisacodyl tablets designed to deliberately create inadequately prepped colons.
The team found that the Pure-Vu system significantly increased the number of participants with an adequate cleansing level from 31% at baseline to 98% after use of the device.
Inadequately prepped colons put a burden on the healthcare system, as patients are sometimes told that they must return for a 2nd procedure. In-patient procedures are even trickier, Pomeranz said, because often these patients need to spend 2 days in a hospital bed just to get them clean enough for a quality exam.
“You can imagine the cost of that,” Pomeranz told us. “You’re looking at anywhere between $1,800 to $2,000 a day just for the cost of a hospital bed.”
Reimbursement for physicians is also challenged by poor colonoscopy prep, he said. “The reimbursement is only going to get worse if [doctors] don’t have a successful outcome and we actually see more and more things happening where the burden of prep is going to start to move more into the physician side than the patient side.
“Obviously with all that burden, there is certainly significant opportunities with a device that can clean the colon incredibly well to help change that whole structure and paradigm and really revolutionize the whole experience,” Pomeranz said.
The Pure-Vu system won 510(k) clearance from the FDA in September 2016; Pomeranz told us that the company will soon pursue CE Mark approval in the European Union.