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At Indigo Orb, Inc. we conduct clinical studies that are carefully designed to safeguard the health of the participants as well as answer specific research questions. We have conducted and continue to run clinical trials to gather additional data on the efficacy, safety and utility of the Episure AutoDetect Syringe at multiple centers throughout the country. Our goal is to provide a product that has been validated through rigorous research for the anesthesia provider and to ultimately raise the level of care provided to patients receiving an epidural.


Stanford University   

Principal Investigators: Brendan Carvalho, MBBCh, FRCA, Edward Riley, MD

In the study “A New Loss of Resistance Syringe for Epidural Placement” conducted at Stanford University, the Episure AutoDetect Syringe reliably detected needle entry in the epidural space in a laboratory and animal (pig) model and clinically in women receiving labor epidurals. This work was presented at the 2005 Annual ASA meeting.

A full manuscript of this study with additional experiences on 30 laboring women with the Episure AutoDetect Syringe has been published in Anesthesia and Analgesia in the October 2007 issue (Vol. 105, No. 4). Similar to the initial findings presented, the Episure AutoDetect Syringe reliably identified the epidural space in laboring women with no false LORs or accidental dural punctures.

Duke University   

Principal Investigators: Ashraf Habib, MBBCh, MSc, FRCA, Ronald George, MD, FRCPC, Terrance Allen, MBBS, FRCA, Adeyemi Olufolabi, MB, FRCA

A recent prospective study “A Comparison Between the Glass Syringe and the Episure AutoDetect Syringe for Identifying the Epidural Space Using the Loss of Resistance Technique” conducted at Duke University, 325 laboring patients received an epidural with the Episure AutoDetect Syringe to compare the traditional glass syringe to the Episure AutoDetect Syringe in identifying the epidural space. The study participants included attending physicians and resident physicians. Investigators found that the Episure AutoDetect Syringe reliably and quickly identified the epidural space in laboring patients.

The abstract of the study findings was presented at the May 2007 SOAP Conference.

A full manuscript of this study has been published in Anesthesia and Analgesia in the February 2008 issue (Vol. 106, No. 2). The primary conclusion was that epidural analgesia failed in five subjects in the glass syringe group and in no subject in the Episure syringe group.

Wayne State University   

Principal Investigators: Vitaly Soskin, MD, PhD, H.M.Marsh, MB, BS, M. Marjanovic, MD, Z. Injic, BSc, MSA, T. Tenenboym, CRNA, K. Crawforth, CRNA, PhD, D. Deppen, CRNA, J. Cox, CRNA, A. Raiskin, MD, K.Ferguson, MD, A. Shaloub, MD, G. Yu, MD

In a recent prospective study “New AutoDetect Syringe For Labor Epidural Analgesia” conducted at Wayne State University, 161 laboring patients received an epidural with the Episure AutoDetect Syringe. The study participants included attending physicians, CRNAs and residents and showed that the Episure AutoDetect Syringe helps more accurately and more objectively identify the epidural space, providing more stability and allowing more controlled movement. Overall, the participants believe that the Episure AutoDetect Syringe “is a good learning tool, especially for anesthesia residents and could be a very useful addition to the Anesthesia Department”. The attending physicians reported that using two hands during epidural placement with the Episure AutoDetect Syringe was an advantage of the Episure AutoDetect Syringe over the traditional LOR syringe.

The abstract of the study findings was presented at the May 2007 SOAP Conference.


Current Studies Underway

Brigham & Women’s Hospital   Principal Investigators: Lawrence Tsen, M.D., Jeanne Carebuena, M.D.
Expected date: SOAP 2008