A Medical Device Daily

E-Z-EM (Lake Success, New York) reported the results of a study presented at the 2005 Digestive Disease Week (DDW) meeting, concluding today in Chicago, those results indicating that computed tomography enterography (CTE) is superior to capsule endoscopy in detecting Crohn’s disease (CD) in the small bowel (SB) as measured by specificity and overall accuracy, and provided comparable sensitivity.

CTE is a study that uses an oral contrast, like VoLumen low Hounsfield value oral contrast, to distend the bowel and improve bowel wall visualization.

The 42-patient study – “Small Bowel Imaging in Crohn’s Disease: A Prospective, Blinded, 4-Way Comparison Trial” – by researchers at the Mayo Clinic (Rochester, New York) evaluated the sensitivity, specificity and accuracy of CT Enterography (CTE), ileocolonoscopy (IC), capsule endos-copy (CE) and small bowel follow-through (SBFT) in the diagnosis of Crohn’s disease in the small bowel.

The study showed that CTE with VoLumen and CE “have similarly high sensitivity – 82% and 83% respectively – for detecting active Crohn’s disease, and appear to be superior to IC and SBFT – 74% and 65% respectively,” according to a statement from E-Z-EM. “The specificity for CTE with VoLumen was 89%, as compared to 100% for IC, 94% for SBFT, and only 53% for CE. As measured by general accuracy, CTE with VoLumen was comparable to IC – 85% and 86% respectively – and superior to both CE (67%) and SBFT (79%).”

Anthony Lombardo, president and CEO of E-Z-EM, said, “Small bowel imaging is often done prior to capsule endoscopy due to the risk of capsule retention in an undetected blockage. These results strongly suggest that for suspected Crohn’s disease, small bowel imaging with CTE can obviate the need for follow-up study with capsule endoscopy.”

He said that, together with previous research, the study supports the “expanding role for CTE and VoLumen in the diagnosis of Crohn’s disease. In fact, researchers involved in this study have since standardized the use of VoLumen in their CTE procedures.”

E-Z-EM makes contrast agents for gastrointestinal radiology. It recently introduced VoLumen, calling it “the next-generation, low-density barium sulfate suspension for use as an oral contrast in multidetector CT and PET/CT studies.”

The company also offers Empower – a family of CT injectors on the market with patented EDA and offering a complete product set for virtual colonoscopy.

In other reports from the meeting:

• Boston Scientific (Natick, Massachusetts) reported results from two canine studies assessing effectiveness, safety and ulcer healing rates of the company’s Resolution Clip Device in controlling gastrointestinal bleeding as compared with other endoscopic hemoclips, thermal coagulation and epinephrine injection treatments.

The Resolution Clip – a pre-loaded, ready-to-use clip device, intended for hemostasis of bleeding gastric ulcers, among other indications – features an 11 mm-wide jaw span, designed to grasp enough tissue to improve wound closure.

Data presented showed that clip retention rates at one and two weeks post-procedure were higher for the Resolution Clip compared with the Olympus and Wilson-Cook brand clips.

Dennis Jensen, MD, professor of medicine in the Gas-trointestinal Division at the University of California Los Angeles School of Medicine, a principal study investigator, said that the studies “provide physicians with new endoscopic comparative laboratory data concerning the strengths and weaknesses of various techniques for hemostasis of bleeding acute gastric ulcers.” He added that the data “suggest that the use and retention of hemostatic clips may accelerate the healing of gastric ulcers in comparison to thermal coagulation. Boston Scientific’s Resolution Clip had significantly higher retention rates compared to the other approved hemostatic clips that were studied.”

He said further comparative human trials will help to define the best clinical applications and indications of the hemoclips as compared to “older hemostasis methods such as thermocoagulation.”

In addition, canine gastric ulcer healing rates were compared for hemoclips vs. multipolar electrocoagulation (MPEC). The study yielded similar results, indicating significantly higher retention rates for the Resolution Clip at one and two weeks post-procedure. Retained clips appeared to accelerate rather than delay gastric ulcer healing relative to control or MPEC.

The Resolution Clip is FDA-cleared and available for distribution worldwide, Boston Sci said.