P>• etrials Worldwide(Morrisville, North Carolina), which offers fully integrated, easy-to-use eClinical software for the clinical trial process, reported that it has deployed a hybrid clinical study that includes both paper-based and electronic data capture tools for data collection. The study is being conducted in about 1,500 European-based sites with a projected 7,070 patients expected to enroll. Each site participating in the trial has the option to select either etrials Electronic Data Capture (EDC) technology that produces electronic case report forms, or paper-based case report forms to record and report clinical data. All data collected on paper is then entered into the EDC tool for data cleaning and review.

• A patient undergoing treatment for clogged coronary arteries at the Center for Interventional Vascular Therapy at NewYork-Presbyterian Hospital has become the first to successfully receive targeted renal therapy (TRT) with FlowMedica’s (Fremont, California) Benephit Delta Infusion Sys-tem, a new device designed to help prevent kidney dysfunction in certain patients undergoing certain coronary procedures. In addition to chronic kidney disease, the patient suffers from congestive heart failure (CHF). The company said the combination of these conditions “greatly increased” the patient’s risk of developing kidney failure from the contrast media used during his angiography and stenting procedures. The Benephit Delta system is a catheter-based medical device that enables the administration of physician-specified medications and other therapeutic agents directly to the renal arteries. It is designed to provide selective infusion to both renal arteries simultaneously, using a single catheter. It received 510(k) clearance from the FDA earlier this year. The Benephit Delta is designed to provide TRT, an alternative to systemic intravenous infusion of medications to treat kidney dysfunction that is related to a number of conditions, including cardiovascular procedures and diseases such as CHF. The Benephit Delta system was used to deliver a medication (fenoldopam) directly into the patient’s kidneys through the renal arteries. Fenoldopam increases blood flow inside the kidneys. The patient did not develop radiocontrast nephropathy (RCN). Cardiologists have estimated that 20% of patients undergoing coronary interventions could benefit from TRT for RCN.

• InSightec (Haifa, Israel) said that five U.S. clinical sites are enrolling African-American women in a post-marketing study to evaluate the efficacy of its ExAblate 2000 in treating uterine fibroids. The study is an element of the FDA’s October 2004 approval for ExAblate. African-American women are three to five times more likely to develop uterine fibroids than their Caucasian counterparts. The study is to confirm the efficacy of the ExAblate treatment in African-American women, as they tend to have more severe uterine fibroids. The study is open to African-American women who have symptomatic uterine fibroids, have completed their families and are not contraindicated for MRI. It includes a 36-month follow-up to evaluate long-term efficacy of the treatment. ExAblate combines MRI and high-intensity ultrasound to thermally ablate tissue. The ExAblate 2000 is compatible only with GE Healthcare’s Signa MR systems.