The Aero-O-Scope camera boasts a feature called Omnivision – which enables 360 degree viewing of the colon, including inside hard-to-see folds where polyps tend to grow.Self-interest wasn’t really Ben Goldwasser’s motivation when he co-founded Israeli startup GI-View two and a half years ago. But Goldwasser doesn’t mind one bit that the device his company has developed – a miniaturized, self-propelling, self-navigating and disposable colonoscopic camera called the Aer-O-Scope – will also benefit him.
“When I reached the age of 50, and began to require annual medical checkups, the idea of a colonoscopy seemed just a bit aggressive,” he told ISRAEL21c. “In this day, when you have miniature cameras in cell phones, and can conduct heart surgery via a camera in a catheter, why should one have to suffer a colonoscopy? There had to be an easier way.”
Goldwasser and GI View has discovered that easier way. The Aer-O-Scope uses a balloon and air pressure to carry a miniature camera though the bowel. The camera boasts a feature called Omnivision – which enables 360 degree viewing of the colon, including inside hard-to-see folds where polyps tend to grow.
A study, published as the cover story in the March 2006 issue of the medical journal Gastroentology, reported that in trials conducted in Croatia, the device made it through the entire length of the colon in 10 of 12 people.
According to Professor Nadir Arber, head of the Department for Cancer Prevention at the Tel Aviv Sourasky Medical Center, and president of GI View’s scientific advisory board, the Aer-O-Scope provides images comparable with those of a standard colonoscopy, but with virtually none of the discomfort.
“I’ve closely followed the development of the device, as well as the conduct of the trials. And I can say it’s a fascinating breakthrough. It’s a new technology that can replace the colonoscopy as a diagnostic tool,” Arber told ISRAEL21c.
The idea of using a camera in a device that moves through the colon is not new, according to Goldwasser, who trained at Duke and the Mayo Clinic before becoming professor and chairman of the department of urology at Tel Hashomer Medical Center in the 1980s.
“The reason others failed is because they tried to think of motion in a classical sense – as motion created by traction – whether it’s traction on the ground when you’re walking or traction on the road,” he explained.
“The colon is covered with mucous – which makes it slippery, much like ice. And like walking on ice, you have to glide. So the idea of the motion balloon came to us. If you have a balloon that can change its shape and diameter according to the changing shape of a colon, it could work like a piston inside an engine’s cylinder. Just like a cylinder is driven by the air pressure, if you take a balloon that accommodates to the size and shape of the area it’s in, it can be driven forward.”
The device consists of a disposal unit with a rectal introducer, supply cable and scope contained within a scanning balloon, plus an automated console that directs the action under the guidance of a technician.
The operator introduces the device into the rectum, and presses the forward button on the control panel. First the rectal balloon is inflated and then the scanner balloon with the embedded electro optical capsule is inflated.
Pressure sensors within the workstation continuously measure the pressure inside, in front of and behind the scanner balloon. The console computer automatically controls the pressure in all three compartments and ensures that the balloon moves forward at the lowest possible pressure.
At any time during the forward or reverse motion of the scanner balloon, the operator may press the pause or stop buttons. Pause can be used to gain a better look with the camera or to change the direction of balloon motion. Stop can be used to instantly deflate all compartments, for instance if the patient requests a rest.
“Because the Aer-O-Scope is not pushed into the colon like a standard colonoscope but rather advances itself while assuming the shape of the colon, it is likely less traumatic to the colonic wall and is expected to cause less pain,” Arber wrote in the Gastroentology report.
While the Aer-O-Scope may perform viewing on its way in, the more detailed viewing occurs on the way out when the colon in front of the camera is insufflated and the mucosal folds are thus flattened. According to Goldwasser, polyps are often hidden in the folds of the colon, like wrinkled skin.
“The doctors can have a real time view of the colon. If he notices something suspicious, he can take a snap shot with a button on the control panel, and in addition, the entire exam is recorded onto a CD for later inspection,” said Goldwasser.
The supply cable provides water, air and suction to enable clear viewing of the colon by the optical camera.
“An optical system can become dirty traveling through the colon – so water is needed to keep it clean. And even after a good bowel movement, there is often some liquid left inside the colon which obstructs the surface, so you need suction,” said Goldwasser.
Illumination for the optical system is provided by white LED’s. The digital data generated is stored in the work station, and the images are then reconstructed to form of a seamless picture of the entire colon.
“The camera that we’ve developed has never before been used in medicine – it has a regular front viewing lens, but we’ve added a new technology taken from the security world called Omnivision – which allows for 360 degree vision. It also has the ability to see behind the folds of the colon from all angles.”
According to Goldwasser, the Aer-O-Scope has been tested on over 40 human studies, and over 300 animals.
“We still need to perfect the process, but it’s come a long way. It’s no longer just an idea. By the end of the year, we hope to begin FDA trials, and hope to have approval by mid-2007,” he said.
In the trials conducted in Croatia, highlighted in Gastroentology, the pressures recorded were significantly lower than those reported during standard colonoscopy and comparable to those reported during virtual colonoscopy.
Two of the volunteers asked for analgesics during the procedure, and four of the volunteers had sweating and reported a bloating sensation that resolved spontaneously within a few minutes. There were no apparent complications either during the colonoscopy, in a standard colonoscopy that followed the procedure, or up to one month later.
According to Arber, the process takes only 15 minutes, and the procedure to clean the bowels before the Aer-O-Scope is inserted is more unpleasant than the colonoscopy itself.
Goldwasser stressed that the Aer-O-Scope is intended for diagnostic use only, and therefore does not contain a working channel for therapeutic instruments to remove polyps.
Besides providing a more pleasant colonoscopy procedure, the Aer-O-Scope will help to lower in the incidence of colon cancer mortality, wrote Arber in the Gastroentology study.
“Despite the shown benefits of screening, incidence and mortality rates of this common cancer remain high. Mass screening efforts have been compromised by performance limitations and low user rates of the tools currently available. Better screening techniques are needed that combine the features of accuracy, minimal invasiveness, convenience, safety, widespread access, and affordability.”
For Goldwasser, the success of the Aer-O-Scope has been vindication for his decision to leave behind a lucrative career as head of venture capital fund Biomed – which involved investments from the likes of pharmaceutical giant Teva and the Israeli scions, the Arison family.
Despite his high connections, Goldwasser is certain that GI View, which is primarily funded by the Israel Health Care Venture Fund, is going to make it on its own merit. And it also has nothing to do with making his own annual colonoscopy less unpleasant.
“I don’t think people and investors would have been interested if it was only about protecting my gentle behind.”