NOSCAR announces NOTES multicenter human trials in the US
The Natural Orifice Surgery Consortium for Assessment and Research® (NOSCAR®), a joint effort of the American Society for Gastrointestinal Endoscopy (ASGE) and the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), announces the first Natural Orifice Translumenal Endoscopic Surgery® (NOTES®) multicenter human trial in the United States. Until now, NOSCAR research efforts have focused on basic research. The next phase will involve critical human trials. Continuing research commitments from industry partners Ethicon Endo-Surgery, Olympus America Inc. and Stryker Medical will provide funds to support the study in this emerging transdisciplinary therapy. The landmark study was announced at the 4th International Conference on NOTES in Boston where nearly 300 physicians and industry representatives gathered to learn the latest information about the science and technology of the medical platform.
"NOSCAR is taking a big step forward later this year with the commencement of the first NOTES multicenter human trial in the U.S. We are grateful to our partners at Ethicon Endo-Surgery, Olympus America Inc. and Stryker Medical for helping make the study possible," said Michael L. Kochman, MD, NOSCAR Research Subcommittee co-chair.
The human studies are expected to begin later this year. NOSCAR leadership is currently finalizing the design for a prospective multicenter trial of NOTES cholecystectomy (gallbladder removal) versus conventional laparoscopic cholecystectomy. NOSCAR will be granting funds to selected institutions to conduct these trials. Institutions participating in the trial have demonstrated a strong commitment to developing the basic science that forms the foundation of NOTES and have already performed human NOTES cases under an Institutional Review Board protocol; approximately 200 patients will be enrolled in the clinical trial.
NOSCAR will make additional announcements regarding the participating institutions, study protocols and when studies will commence. ACI, a Clinical Research Organization based in Pennsylvania, has been retained to provide data collection and report preparation services for the study.
"We are delighted that the research and science to date has led us to the point where we can begin conducting human trials. The careful, responsible introduction of NOTES is our utmost concern; this study will provide the basis for such an introduction," said Steven D. Schwaitzberg, MD, NOSCAR Research Subcommittee co-chair.
Source: American Society for Gastrointestinal Endoscopy
