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CIMIT supports NOTES initiative with $2.1M grant

Team will focus on minimally invasive surgery that leaves no scars,
minimizes infection

At the February 5 CIMIT Forum to celebrate the launch of its 10th Anniversary year, Executive Director John Parrish, MD, announced the winning project for CIMIT's $2.1 million Strategic Project. The award will go to a team pioneering a dynamic new technology promising the future possibility of surgical procedures without making incisions on the surface of the body.

The multi-institutional initiative chosen was NOTES (Natural Orifice Translumenal Endoscopic Surgery). The award of $700,000 annually for three years represents CIMIT's largest grant program. With this award, CIMIT's investment in NOTES research will top $3 million overall, making CIMIT the largest financial sponsor of this technology worldwide.

NOTES is a national initiative, led by a multi-disciplinary collaboration of leading surgeons and endoscopists. NOTES has garnered significant private support as well, as Ethicon Endo-Surgery ($1 million), Covidien ($500,000) and Olympus ($500,000) already have committed funds for research.

NOTES is a novel technique of performing surgical procedures. It utilizes flexible endoscopes through the mouth, anus or vagina to enter the abdominal, pelvic or thoracic cavities.

"More research and a greater number of carefully planned human trials must be done," said David Rattner, MD, chief of the Division of General and Gastrointestinal Surgery at Massachusetts General Hospital and a leader of a national coalition of doctors interested in NOTES. "But I think I can say NOTES has great potential to help patients."

Dr. Rattner leads the Boston-based NOTES initiative together with Christopher Thompson, MD, MS, director of developmental endoscopy at Brigham and Women's Hospital; William Brugge, MD, director of endoscopy at Massachusetts General Hospital; and Richard Rothstein, MD, chief of gastroenterology at Dartmouth Medical Center.

"In selecting NOTES as the first CIMIT Strategic Project, we are looking for a breakthrough that has the potential for significant impact on medical care in a relatively short period of time," said Dr. Parrish. "NOTES is an innovative approach to surgery, and we are excited with its potential to dramatically transform minimally invasive surgery. More importantly, because NOTES may eventually be performed in austere, non-sterile conditions, it could be a valuable new approach in developing countries as well," he added.

Patients will benefit

Eventually, patients will benefit because NOTES leaves no scars and causes less pain. There is also less chance of infection. Employers will see a positive effect, because workers will return to the job more quickly. And those in developing countries could benefit as well, because NOTES systems would be transportable, with little post-operative care required.

Before extensive human trials can be launched, a fail-safe method to enter cavities and then close the access site is needed. Also, the lack of small, supple instruments is a major challenge facing NOTES.

The emergence of NOTES will require new tools and medical devices, but many medical manufacturers are providing financial support through research grants, sponsorships of medical conferences and other means. Corporate supporters of the national NOTES initiative have included Covidien, Ethicon Endo-Surgery, a Johnson & Johnson company, Olympus, Power Medical Interventions, Boston Scientific, Storz Endoscopy, Stryker, Cook Medical, Davol, Intuitive Surgical, Pentax and USGI Richard Wolf.

"We are going to see rapid development of this technology due to the high level of interest from industry," said Dr. Thompson. Researchers from around the country are sharing their information.

NOTES relies on a multi-disciplinary team having the skills of both an advanced therapeutic endoscopist and a laparoscopic surgeon. The procedure has stimulated much interest in the medical community, as it is an evolution of laparoscopy, the minimally invasive technique that has gained popularity since the '80s.

Nationally, the NOTES initiative has been building momentum. Leading this multi-city, multi-institutional collaboration are surgeons and endoscopists from the leading academic medical centers.

"This Boston-based project will be a major contribution to our national effort," said Mark A. Talamini, MD, professor and chair of the Department of Surgery at UC San Diego Medical Center. Dr. Talamini and his team performed California's first NOTES procedures on two San Diego women, removing gallbladders through the vagina during 90-minute procedures. "Our first two patients had almost no pain, with one taking no narcotics at all. That would be unusual for a standard laparoscopic cholecystectomy. At this stage, we have no idea whether this is a better way to do surgery. It's hard to predict the future of surgery, but you can be sure we will be doing surgery differently than we do it today."

A stable, working platform

NOTES has the potential of being the next breakthrough in minimally invasive surgery, providing patients with scarless, relatively painless procedures while cutting costs at the medical center. It can emerge as a new "stable working platform" that will be a disruptive technology having many surgical applications, including gastric bypass, fallopian tubal ligation, removal of ovaries and diagnostic work.

"I have worked with David since the early days of CIMIT," said Keith Isaacson, MD, medical director for the Minimally Invasive Gynecological Surgery Unit at Newton- Wellesley Hospital. "This project will be very important to our work in gynecological surgery. We will be watching their progress very closely, especially their functional work in establishing a platform for tissue manipulation, because we are positioned to become early adopters of their improvements to patient care."

Dr. Isaacson added, "Gynecologists have accessed the abdominal cavity through the vagina for over 50 years. The novel instrumentation that I anticipate will be created by Dr. Rattner's team will allow us to perform procedures with vaginal access we never thought was possible."

A national collaboration

A key element of the NOTES initiative is the multi-city and multi-institutional collaborations that have emerged through the support of industry organizations such as SAGES (Society of American Gastrointestinal and Endoscopic Surgeons) and ASGE (American Society for Gastrointestinal Endoscopy). A joint effort, initiated by the society presidents at the time, led to the creation of the Natural Orifice Surgery Consortium for Assessment and Research, called NOSCAR.

Robert H. Hawes, MD, professor of medicine at the Medical University of South Carolina and Dr. Rattner served, respectively, as ASGE and SAGES presidents.

"NOTES requires the development of devices and techniques to perform procedures safely before it will be adopted," Dr. Hawes remarked. "This Boston team proposes a comprehensive and systematic set of projects that will clearly advance the discipline of NOTES. The success of this project could lead to a vast improvement of the way we do both relatively routine procedures, such as hernia repairs, up to and including transforming the more sophisticated procedures such as cardiac surgery."

A multi-institutional, multi-disciplinary Boston-based team

The Boston-based NOTES team represents four institutions and three scientific disciplines - medicine, surgery and engineering. Investigators include the following: from Massachusetts General Hospital, Dr. Rattner; Dr. Brugge; Field Willingham, MD; Denise Gee, MD; Patricia Sylla, MD; from Brigham and Women's Hospital, Dr. Thompson and Marvin Ryou, MD; from Dartmouth Medical Center, Dr. Rothstein; and from MIT, Jeffrey Lang, PhD.

The research will focus on areas where NOTES would appear to have a distinct advantage over laparoscopic and thorascopic approaches. This $2.1 million CIMIT Strategic Project grant is a new CIMIT initiative to provide comprehensive research support of innovative medical technology. This is a major commitment for CIMIT, whose grants are generally limited to one year and between $40,000 and $100,000 per award.

CIMIT was an early supporter of NOTES. In 2003 CIMIT funded Dr. Thompson's early NOTES research that led to publication of the first successful experimental NOTES organ resection. Additionally, in 2005 Drs. Rattner and Thompson founded and now co-direct the CIMIT NOTES working group. This group has produced several key publications and helped shape the development of NOTES. CIMIT subsequently sponsored the first national NOSCAR meeting in July 2005.

About CIMIT

CIMIT is the Center for Integration of Medicine and Innovative Technology. It is a non-profit consortium of Boston-area teaching hospitals and engineering schools. Consortium members are Beth Israel Deaconess Medical Center, Boston Medical Center, Boston University, Brigham and Women's Hospital, Charles Stark Draper Laboratory, Children's Hospital Boston, Harvard Medical School, Massachusetts General Hospital, Massachusetts Institute of Technology, Newton-Wellesley Hospital and Partners HealthCare System.

CIMIT provides innovators with resources to explore, develop and implement novel technological solutions for today's most urgent healthcare problems. In 2007, CIMIT committed close to $5 million for early-stage research in medical devices and clinical systems innovation.