CINCINNATI—The U.S. Food and Drug Administration (FDA) granted approval of Ethicon Endo-Surgery’s Investigational Device Exemption (IDE) application to conduct the first study of devices designed for use in natural orifice translumenal endoscopic surgery (NOTES).
The company is the first to receive an IDE to investigate devices specifically designed for natural orifice surgery. The feasibility trial will primarily evaluate the safety of the Ethicon Endo-Surgery NOTES Toolbox, a comprehensive suite of devices specifically designed for this new approach to surgery.
During NOTES, an endoscope is passed through a natural orifice (e.g., mouth, vagina) then through an internal incision in the stomach, bladder, colon or uterus, thus avoiding any external incisions or scars.
The study will include up to 40 subjects undergoing either a cholecystectomy (gallbladder removal) or diagnostic peritoneoscopy (exploratory surgery to investigate chronic pelvic pain). Surgeons will use one of four different NOTES techniques supplemented with laparoscopic assistance. In addition to evaluating the safety of the Ethicon Endo-Surgery NOTES Toolbox, the study is also designed to collect qualitative outcomes data and healthcare economic variables.
“We are excited about the potential benefits of NOTES to patients and the overall healthcare industry,” said Karen Licitra, company group chairperson of Ethicon Endo-Surgery. “An integral piece to advancing NOTES surgery responsibly is ensuring surgeons have the proper technology at hand. This IDE represents an important step for Ethicon Endo-Surgery in fulfilling that need by pursuing a NOTES-specific indication for the NOTES Toolbox.”
The four sites participating in the trial are Northwestern University Feinberg School of Medicine; University of California-San Diego Medical Center; The Ohio State University Center for Minimally Invasive Surgery; and, the University of Missouri University Hospital. Each clinical trial site will investigate one of four methods—transgastric (through the mouth) and transvaginal (through the vagina) cholecystectomies and transgastric and transvaginal diagnostic peritoneoscopies.