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Study Says "Sedationless" Colonoscopy a Possibility

by Joan Trombetti, Writer | June 18, 2007
The SC40 promises to be gentle
(click to enlarge)
WASHINGTON, D.C. -- Invendo Medical, an emerging medical device company, disclosed clinical data at Digestive Disease Week 2007 that demonstrates patients can undergo a colonoscopy without sedation and still feel no pain. Invendo gathered the data from a pilot study using its breakthrough technology called the invendoscope SC40, which is CE-marked and approved for sale in Europe. DDW is the largest international gathering of physicians and researchers in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery.

The pilot study's results were disclosed by Prof. Thomas Rosch, M.D., of Charite University Hospitals Berlin (Germany), in a poster session at DDW 2007. The poster is entitled: "A prospective pilot study to assess technical performance of a new single-use colonoscope with inverted sleeve technology." The study was a proof-of-principle study on 28 asymptomatic paid volunteers (12 males, 16 females, mean age 48 years, range 23-68 years), who consented to undergo sedation-free total colonoscopy with the new invendo medical device. The study was approved by the Charite Ethical Committee and University of Frankfurt Ethical Committee.

"Our pilot study with invendo's new colonoscope SC40 was performed without pain in 92% of the cases. No sedation was given to any patient, and no complications occurred," said Prof. Rosch, who is Chief of Endoscopy at Charite University Hospitals Berlin (Germany). "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. 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."

Colon cancer has the second-highest incidence of cancers worldwide. It can be beaten if diagnosed early. Unfortunately, while colonoscopy is the undisputed gold standard for diagnosis of colon cancer, it has very low acceptance by patients. Indeed, only a relatively small percentage of the eligible population worldwide undergoes colon cancer screening. "Given the dire need for improved acceptance by potential screenees, we are extremely pleased with the results of this pilot study," said Konstantin Bob, M.D., Chief Technical Officer and Co-Founder of invendo medical. "There are several reasons for lack of acceptance of colon cancer screening, but certainly the pain associated with conventional colonoscopy and the subsequent need for sedation are what keep a majority of eligible patients from being screened. We therefore believe that our new device might play a major role in significantly increasing the number of persons who will undergo a colonoscopy."

The invendoscope is not available for sale. Only for clinical investigational use and exhibition purposes. Not FDA approved.