AccuCirc® Clinical Publications and Trial Data
The AccuCirc® technology is defined by three core elements: a low-profile shield that eliminates the need for a dorsal crush and slit, a foreskin holder that enables precise alignment without a safety pin, and a design safeguard that prevents mismatching of device components. These features are fundamental to both the disposable and reusable AccuCirc® configurations.
The technology was first clinically evaluated in 2005 at Hasbro Children’s Hospital in Providence, Rhode Island, under the leadership of Anthony Caldamone, MD, Professor of Surgery and Chief of Pediatric Urology at Brown University. In 2007, the low-profile shield and foreskin-holding components underwent further evaluation at Women & Infants Hospital. This early clinical development was followed by multicenter evaluation in Nigeria and FDA 510(k) clearance of the AccuCirc device in 2007. [Link to FDA 510(k) clearance summary]
Over the past two decades, the AccuCirc® technology has been used in more than 20,000 procedures worldwide. Published field studies have evaluated its use across diverse clinical environments, including settings in which procedures were performed by trained non-physician providers.
In 2018, large field studies were conducted in Zimbabwe and Kenya. A total of 1,204 procedures were performed: 500 by nurse-midwives in Zimbabwe and 704 by trained clinicians in Kenya. The median participant ages were 22 days and 16 days, respectively. Both studies reported 100% follow-up, with no device-related injuries or surgical revisions.
The published evidence has consistently emphasized the device’s protective design and its potential application within structured early infant male circumcision programs. Explore the peer-reviewed studies below, including research examining clinical outcomes, provider experience, training, and implementation.
Related procedural and safety evidence
Peer-reviewed publications
February 2018
PLOS ONE
“This evaluation of the AccuCirc is the largest to date and indicates that the device is safe and acceptable, achieving high levels of parental satisfaction.”
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February 2017
PLOS ONE
“All providers agreed that AccuCirc would be the device they would recommend for a national program.”
“The AccuCirc device may be the safest and most preferred device for use in national early infant male circumcision programs.”
“In our study, providers unanimously expressed the view that the AccuCirc would be the safest and most appropriate for a national early infant male circumcision program.”
“In our study, we found the AccuCirc kit to be extremely convenient, requiring minimal purchasing and inventory of consumables, and no need for timely instrument disinfection process.”
“In a large early infant male circumcision program, simplification of supply-chain management and the elimination of the need for reusable inventory and sterilization will be significant advantages of the AccuCirc.”
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July 2016
Global Health: Science and Practice
“Early infant male circumcision conducted by nurse-midwives using the AccuCirc device proved safe, feasible, and acceptable to parents in Zimbabwe. The AccuCirc device has the potential to facilitate widespread scale-up of safe early infant male circumcision in sub-Saharan Africa.”
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August 2015
Journal of Acquired Immune Deficiency Syndromes
“Early infant male circumcision has a lower unit cost when using AccuCirc compared with the Mogen clamp.”
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August 2015
Journal of Acquired Immune Deficiency Syndromes
“The first randomized trial of AccuCirc versus Mogen clamp demonstrated that early infant male circumcision using these devices is safe and acceptable to parents.”
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May 2014
Single-Arm Evaluation of the AccuCirc Device for Early Infant Male Circumcision in Botswana
Journal of Acquired Immune Deficiency Syndromes
“The AccuCirc is safe, and it should be considered for programmatic early infant male circumcision in resource-limited settings.”
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Conference Abstracts and Presentations
July 2010
Using a Foreskin Holder and Surgical Pen Mark for Improved Alignment Prior to Early Infant Male Circumcision
International AIDS Conference — conference abstract or presentation format to be confirmed
July 2009
The Atraumatic Circumcision Device (AccuCirc): A Comparison of Postoperative Outcomes at Two Weeks
International AIDS Conference — conference abstract or presentation format to be confirmed
August 2008
The Atraumatic Circumcision Device (AccuCirc): A New Technology for the Prevention of Male Circumcision Complications and HIV Risk Associated With Contaminated Components in African Children
International AIDS Conference — conference abstract or presentation format to be confirmed