Covidien supports NOSCAR US multicenter human trial

July 08, 2011

OAK BROOK, Ill., July 8, 2011 - 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), is pleased to announce a grant from Covidien to support the U.S. multicenter human trial on transoral and transvaginal cholecystectomies (gallbladder removal) using Natural Orifice Translumenal Endoscopic Surgery® (NOTES®).

"NOSCAR is grateful to Covidien for supporting the NOTES human trial research and helping to advance this minimally invasive technique," said Steven D. Schwaitzberg, MD, NOSCAR Research Subcommittee Co-Chair.

Cholecystectomy, or gallbladder removal, is one of the most common surgeries in the U.S.; approximately 750,000 are performed annually. The NOSCAR study uses the mouth or vagina as routes to the gallbladder. Rather than making up to five incisions in the abdominal wall, tools are passed down the mouth and through a hole created in the stomach (transoral/transgastric) or through the vagina (transvaginal).

The prospective multicenter trial compares NOTES cholecystectomy versus conventional laparoscopic cholecystectomy. NOSCAR has granted 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.

"Covidien is dedicated to collaborating with the surgical community to drive the adoption of advanced minimally and non-invasive surgical techniques through well-designed, robust clinical studies," said Michael Tarnoff, M.D., Chief Medical Officer, Covidien. "NOTES may represent the next wave in minimally invasive surgery with significant potential to improve patient outcomes and reduce hospital stays. Covidien is pleased that its funding will support NOSCAR's efforts to ensure the most safe and effective development of NOTES procedures and techniques throughout the world."

"The human trials have already achieved very positive results and we now have a total of five institutions and 35 patients participating in the trial," said Michael L. Kochman, MD, NOSCAR Research Subcommittee Co-Chair.
-end-
If you are interested in participating or referring someone into this study, please contact one of the following sites:

Baystate Medical Center
Springfield, MA
Barbara Burkott, RN, BSN, CCRP
barbara.burkott@baystatehealth.org

Northwestern University
Chicago, IL
Colleen Krantz
ckrantz@nmh.org

The Oregon Clinic
Portland, OR
Angi Gill, RN
agill@orclinic.com

University of California at San Diego Medical Center
San Diego, CA
Sarah Lazar
misresearch@ucsd.edu

Yale University
New Haven, CT
Barbara Beckerman
barbara.beckerman@yale.edu

In addition to Covidien, continuing research commitments from industry partners Ethicon Endo-Surgery, Olympus America Inc., Stryker Medical and KARL STORZ Endoscopy-America are providing funds to support the human study in this emerging transdisciplinary therapy. ACI, a Clinical Research Organization based in Pennsylvania, has been retained to provide data collection and report preparation services for the study.

About NOSCAR

Natural Orifice Translumenal Endoscopic Surgery® (NOTES®) might represent the next major advancement in minimally invasive therapy. To address this emerging technology, a working group consisting of expert laparoscopic surgeons from SAGES and a group of expert interventional endoscopists representing ASGE have joined together as the Natural Orifice Surgery Consortium for Assessment and Research® (NOSCAR®). The growing capabilities of therapeutic flexible endoscopy have ushered in a new era in treatment of gastrointestinal conditions. Refinements in laparoscopic surgery have progressed to the point that complex surgical procedures, such as gastric bypass, can now be performed in a minimally invasive fashion. These trends have set the stage for the development of even less invasive methods to treat conditions in both the gut lumen and in the peritoneal cavity. It seems feasible that major intraperitoneal surgery may one day be performed without skin incisions. The natural orifices may provide the entry point for surgical interventions in the peritoneal cavity thereby avoiding abdominal wall incisions. For more information, visit www.noscar.org.

About the Society of American Gastrointestinal and Endoscopic Surgeons

The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) was founded in 1981 to foster, promote, support and encourage academic, clinical and research achievement in gastrointestinal endoscopic surgery. SAGES members are general and colorectal surgeons who perform endoscopy and laparoscopy as part of their practice as well as surgical residents, fellows, and other allied health personnel. The Society has grown from fewer than 50 original members to more than 5,500 from every state and over 80 countries. Visit www.sages.org for more information.

About the American Society for Gastrointestinal Endoscopy

Since its founding in 1941, the American Society for Gastrointestinal Endoscopy (ASGE) has been dedicated to advancing patient care and digestive health by promoting excellence in gastrointestinal endoscopy. ASGE, with nearly 12,000 members worldwide, promotes the highest standards for endoscopic training and practice, fosters endoscopic research, recognizes distinguished contributions to endoscopy, and is the foremost resource for endoscopic education. Visit www.asge.org and www.screen4coloncancer.org for more information and to find a qualified doctor in your area.

American Society for Gastrointestinal Endoscopy

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