The Tara KLamp, manufactured in Malaysia since the 1990s, has created controversy in South Africa. It is a hinged plastic bracket the size of a small drinking cup. A plastic tube goes over the head of the penis, and the foreskin is pulled up it and painfully crushed by the bracket. Then the whole contraption must be worn at least five days. A 2005 clinical trial in South Africa was stopped early after the device caused far more injuries and infections than surgery did.
The national health ministry has banned it in most of South Africa, but it is still used heavily in KwaZulu-Natal Province, which has the country’s highest AIDS rate and where the Zulu king, Goodwill Zwelithini, reversing 200 years of tradition, ordered that all Zulu men circumcised.
The W.H.O. knows about the stopped trial and is not considering the KLamp, Mr. Warren said.
Plan to circumcise 2 million using new devise complete
The government plans to circumcise two million men in the next two years in an ambitious mass program that aims to reduce HIV transmission rate by 50 percent.
This follows successful trials of a non-surgical method of male circumcision called Prepex which experts say is easy to use and appropriate for the rural settings. Male circumcision has traditionally been performed surgically.
Prepex device is a simple non-surgical method that requires no sterile setting, no injected anesthesia, and it’s a bloodless procedure with no need for sutures.
PrePex has an elastic mechanism that fits closely around an inner ring, trapping the foreskin, which dries up and is removed a week after the placement of the device.
“The Ministry of Health has carried out clinical trials to evaluate this new device for one and a half years,” said Dr Vincent Mutabazi, the lead investigator in the PrePex clinical trials in Rwanda. “After three major clinical trials required by the World Health Organization technical advisory group that reviews innovations on male circumcision devices, we see strong and compelling evidence on the safety, superiority over surgical circumcision and simplicity in the hand of lower cadre health practitioners like nurses.”
Dr. Reed said he had heard that another device, Ali’s Klamp, was being tested in Kenya under protocols that seemed to match W.H.O. requirements. According to Circlist.com, a circumcision information Web site, it is a Turkish device dating to 2007, and works on principles similar to those of the Tara KLamp and another device, the SmartKlamp, approved by the F.D.A. in 2004.
PrePex was cleared by the F.D.A. because it was judged “substantially equivalent” to the SmartKlamp, Ms. Fuerst said. Proving equivalence in safety to an approved device is the fastest way to get approval, she said, although the technology is quite different.
PrePex’s ultimate cost is still being negotiated with donor agencies and foundations, Ms. Fuerst said, but may end up in the $15-to-$20 range, about the same as a surgical circumcision kit.
By DONALD G. McNEIL Jr.