Pilot study demonstrates usefulness of sedationless colonoscopy

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A new technology offers a way for patients to undergo a colonoscopy without sedation and still feel no pain. Details regarding a pilot study involving the invendoscope SC40 technology from invendo medical GmbH were presented this week in Washington, D.C.

The study, presented in a poster session by Thomas Rösch, MD, chief of endoscopy, Charité University Hospitals Berlin, 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. 

“Our pilot study with invendo’s new colonoscope—the invendoscope SC40—was performed without pain in 92 percent of the cases. No sedation was given to any patient, and no complications occurred,” said Rösch. “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.”
Konstantin Bob, MD, chief technical officer and invendo medical co-founder, said “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.”

“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,” Bob added. “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 product has received its CE mark for sale in Europe, and a market launch is expected in 2008. Also, the company said it intends to make a 510(k) submission to the United States FDA sometime next year.