Here’s a roundup of recent clinical trial news:
- Aastrom looks to launch Phase III trial early next year
Aastrom Biosciences Inc. (NSDQ:ASTM), a leading developer of expanded autologous cellular therapies for the treatment of severe cardiovascular diseases, announced that it has submitted to the U.S. Food and Drug Administration (FDA) a special protocol assessment (SPA) describing the company’s proposed Phase 3 clinical development program in critical limb ischemia (CLI). If the FDA concurs with the protocols outlined in the SPA, Aastrom expects to initiate the Phase 3 program in early 2011.
Read more - Salient Surgical’s New Aquamantys3 system with advanced cutting and hemostatic sealing device proves successful in first surgical case
Salient Surgical announced that the company has completed the first human cases in Europe using its new Aquamantys3 System. The new system includes a handpiece that combines for the first time Salient’s patented Transcollation technology for hemostatic sealing of soft tissue and bones with cutting capabilities.
Read more - Recent patient series demonstrates Spirus Medical’s power spiral endoscope enables unprecedented access to GI tract
Spirus Medical Inc., a leading developer of diagnostic and therapeutic advancement systems for gastroenterology announces a series of pan-endoscopies in an average time of 60 minutes, using a flexible endoscope with an integral drive to power a single use spiral component. The initial clinical series, which was conducted outside the U.S., showed unparalleled ability to navigate the intestinal tract.
Read more - OrSense continuous non-invasive hemoglobin monitoring system demonstrates accurate performance during hemorrhage conditions
OrSense Ltd., developer of monitors for non-invasive measurements of various blood parameters, presented in an oral presentation at the American Society of Anesthesiologists (ASA) annual meeting in San Diego, results showing that hemoglobin (Hb) measurements obtained by its NBM 200MP, a non-invasive Hb measurement system, showed accurate performance during hemorrhage conditions compared with invasive point of care (POC) devices.
Read more - Willingness to pay for predictive diagnostic information with no immediate treatment implications: A survey of U.S. residents
Most people preferred diagnostic tests even in the absence of direct treatment consequences — and were willing to pay reasonably large amounts for the opportunity. People valued diagnostic information for a host of health and non-health related reasons. The results held across multiple diseases and across different magnitudes of disease prevalence, test accuracy, and adverse events. This "value of knowing" seems in part a desire for reassurance, and a desire for information even in light of possible bad news, and suggests that conventional cost-effectiveness analyses may underestimate the value of diagnostics.
Read more - Endologix announces publication of clinical trial results supporting anatomical fixation with a suprarenal aortic extension
Endologix Inc. (NSDQ:ELGX), developer of minimally invasive treatments for aortic disorders, announced the publication of results from its pivotal, multicenter, prospective clinical trial of the Company’s Powerlink System for endovascular repair of abdominal aortic aneurysm (AAA) using an anatomical fixation technique with a suprarenal aortic extension.
Read more - Retina Implant presents clinical trial results at the American Academy of Ophthalmology annual meeting
Retina Implant AG, a leading developer of subretinal implants for the visually impaired, is proud to announce co-founder and chairman Dr. Eberhart Zrenner was invited to present the exciting results of clinical trials he has been leading since 2005 by the American Academy of Ophthalmology at this year’s annual meeting Oct. 16-19 at McCormick Place in Chicago, Ill.
Read more - FDA provides update on LASIK quality of life collaboration project status
The U.S. Food and Drug Administration provided an update on a three-part study of LASIK (Laser-Assisted in situ Keratomileusis), a vision improvement procedure.
Read more - NHLBI launches body cooling treatment study for pediatric cardiac arrest
The National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health, has launched the first large-scale, multi-center study to investigate the effectiveness of body cooling treatment in infants and children who have had cardiac arrest. The Therapeutic Hypothermia after Pediatric Cardiac Arrest (THAPCA) trials total more than $21 million over six years.
Read more - BSD Medical reports publication in Internal Medicine News of study results demonstrating improved survival for sarcoma cancer patients treated with hyperthermia
BSD Medical Corporation (NSDQ:BSDM) announced publication in Internal Medicine News Digital Network of new data from the ESHO/EORTC Soft Tissue and Bone Sarcoma Group (STBSG) Phase III clinical study of hyperthermia.
Read more - Medifocus Inc. announces institutional review board (IRB) approval for its Phase III pivotal breast cancer treatment study
Medifocus Inc. (OTC:MDFZF) is pleased to announce that the University of Oklahoma Health Sciences Center’s Institutional Review Board (IRB) has granted final approval to conduct Medifocus’ Pivotal Phase III Breast Cancer Treatment Study at the University of Oklahoma Breast Institute, in Oklahoma City, under the supervision of William C. Dooley, M.D., the Principal Investigator for the Food and Drug Administration (FDA) approved study.
Read more
