Research Professor Thomas R sch, MD, will present data today at Digestive Disease Week in Washington on the use of the Invendo Medical (Kissing, Germany) Invendoscope, a single-use colonoscope that the company is promoting as a large advance on this … shall we say, uncomfortable procedure.
Performed at Charité Hospitals Berlin (Germany), the research data showed that the patients receiving colonoscopy with the Invendoscope were not sedated, and 92% of them reported no pain.
Michael Rosenbruch, VP of marketing and sales for Invendo, told Medical Device Daily that the presentation of the results during today's poster session at DDW is a "milestone" for the company.
"First of all, we're actually the world's first single-use colonoscope . . . including camera head," Rosenbruch said. "You can not only do diagnostics with our instrument, but you can also do biopsies and therapeutic procedures."
The company's poster is titled "A prospective pilot study to assess technical performance of a new single-use colonoscope with inverted sleeve technology."
The study is a proof-of-principle examination of 28 asymptomatic paid volunteers, 12 males and 16 females, ranging in age from 23 to 68 years with a mean age of 48.
The volunteers consented to undergo a colonoscopy with the new Invendoscope — importantly, sedation-free.
In the study, patients were asked on a 1-to-6 scale to describe any discomfort they may have felt during the procedure, with 1 being painlessness, 6 being discomfort that was "unacceptable."
While most gastroenterologists use a pushing and pulling method during a colonoscopy, he said that the Invendoscope is driven in and out of the colon using a unit and a handheld device, "which activates wheels in the driving unit and can drive the scope up to the secum."
Rosenbruch said the "philosophy" behind its Invendoscope is that gastroenterologists don't [want to] do a lot of maneuvers that can lead to what is called "coiling" as doctors try to make turns with a traditional endoscope in the colon. In the worst cases, that can lead to significant pain and discomfort for the patient — depending on their level of sedation — as well as potential perforations of the intestinal wall.
"Our system is in such a way that you look on the monitor and use a joystick to move or steer the tip, and you then you can find the lumen, and you drive according to the anatomy of the colon," he said.
The tip of the device extends or shrinks depending on the needs of the gastroenterologist during the procedure, such that only the tip is pushing through the colon.
"By doing that, we're creating very little force on the colonic wall — much less force than the traditional colonoscopy, and we're basing that on our current study," he said.
"These data are very exciting, because this new technology has the potential to significantly advance the acceptance of patients who should have colonoscopy but are afraid to do so, because they fear pain and have to be sedated," R sch said in a statement.
"While further research is needed, of course, to determine if the Invendo device will best serve the goal of a simple, pain-free, sedationless and accurate colonoscopy, nevertheless these early data are very encouraging."
Rosenbruch said that the experience of pain is highly subjective — with different patients having different pain thresholds.
This device has the potential to increase the number of people who undergo colonoscopies, Rosenbruch said, given its painlessness.
"The issue with colonoscopy is [that], on the one hand, it's the gold standard," he said. "But the word-of-mouth propaganda between patients is, 'It's painful if you're not sedated.'"
Rosenbruch said the company's goal is to create a "positive image" of colonoscopy.
Invendo has applied for FDA 510(k) clearance of the device, and says it expects a response by the end of the year.
The company has CE-marking for the device and will launch it in Europe in 2008, initially in Western Europe. If it receives FDA clearance, it expects U.S. launch also in 2008, Rosenbruch said.