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The Shang Ring: A Novel Male Circumcision Device for HIV Prevention

2014-08-27 03:18:42 | BioPortfolio

Summary

The purpose of this study is to evaluate the Shang Ring, a novel Chinese device for voluntary medical male circumcision, in order to improve the provision of male circumcision services for HIV prevention in Africa.

Description

Three randomized clinical trials (RCTs) have confirmed the benefit of voluntary medical male circumcision (VMMC) in reducing the acquisition of HIV by circumcised men. In Africa, VMMC is most commonly performed with the methods described in the WHO Manual for Male Circumcision under Local Anaesthesia (i.e., the forceps-guided, dorsal slit or sleeve method).

Modelers have estimated that to scale-up VMMC to prevent large numbers of HIV infections will require millions of circumcisions over the next 5 to 10 years, with more than 10 million circumcisions in 2012 based on aggressive scale-up plans.

Neonatal circumcision is a very common procedure and has been the subject of numerous clinical trials. With the use of simple devices, neonatal circumcision is rapid and safe. In contrast, current adult surgical techniques are done freehand. Adolescent or adult male medical circumcision has been a rarely performed procedure in most developed countries. Circumcision has suffered from little or no research that could make possible either (a) comparison or simplification of surgical techniques or (b) development of devices to facilitate the procedure. Current techniques are time consuming and require long training periods to produce skilled personnel. Each procedure typically takes 20 to 40 minutes.

A search for more efficient adult circumcision techniques has been undertaken by consultants for the World Health Organization (WHO) and the Bill & Melinda Gates Foundation. Preliminary discussions that helped to produce this proposal suggest that the Shang Ring is one of the most promising existing devices that could greatly simplify adult circumcision. More efficient and simpler techniques could potentially:

- Reduce the operating time and the cost of supplies

- Improve the safety of the procedure

- Permit more rapid training of non-physician health care providers

- Accelerate the process of scaling up this proven HIV prevention strategy

The Shang Ring is a relatively new device, manufactured by SNNDA, a small company based in Wuhu, China owned by Mr. Shang Jianzhong Shang. It has been approved for marketing in China since 2005, with sales of about 40,000 devices in the past couple of years. The Shang Ring and was awarded the CE Mark by for the European Union in October, 2008. The Shang Ring has the potential to dramatically reduce the time needed for the surgical procedure, from the current 20 to 430 minutes, to an average of about 5 3 to 10 minutes per procedure. This efficiency would greatly increase the productivity of large scale VMMC efforts.

The Shang Ring has several unique advantages compared to other devices that are currently in use, including its suitability for use in adults, small size, simple design, and ease of application. It is a clamp- type device, so there is no need for cautery for hemostasis,, or for suturing for hemostasis, or wound closure. The manufacturer has agreed to negotiate a low public sector price so that it would be affordable for circumcision programs in Africa.

Project goal, objectives and critical milestones: We propose to conduct a multicenter RCT comparing the Shang Ring to standard surgical techniques, with a sample size of 500 men in the Shang Ring group and 500 men in the standard surgery group. We will conduct cost studies to compare time and resources needed for both techniques. We will also assist SNNDA in preparing and submitting dossiers to regulatory authorities in both the United States and at least three African countries, and will assist as needed in SNNDA's application to the U.S. FDA for 510(k) clearance. Circumcision devices are considered class II devices by the U.S. FDA. We will request that the FDA grant marketing clearance for the Shang Ring through a 510(k) process, similar to other recent circumcision device approvals. We propose to conduct these activities over a 30-month period. If successful, they could lead to wide use of the Shang Ring and dramatic efficiencies in scaling up VMMC programs.

Study Design

Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

Male Circumcision

Intervention

Shang Ring circumcision

Location

Homa Bay District Hospital
Homa Bay
Kenya

Status

Recruiting

Source

Weill Medical College of Cornell University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:42-0400

Clinical Trials [508 Associated Clinical Trials listed on BioPortfolio]

Randomized Controlled Trial of Shang Ring Children Circumcision: Comparison Between Flip and No Flip Technique

This is a prospect, randomized control trial to evaluate merits between flip and no flip technique in Shang Ring children circumcision.

Phase II Trial to Evaluate the Safety and Efficacy of the Dry Circumcision Method

The objective of this clinical investigation is to provide the first and preliminary clinical data to study the safety and efficacy of male circumcision where the dry circumcision method i...

Feasibility, Acceptability, and Safety of Neonatal Male Circumcision in Lusaka, Zambia

In this study of neonatal male circumcision (NMC), the investigators will examine acceptability of among parents, feasibility of training providers and implementing services in various cli...

Effect of Male Circumcision on HIV Incidence (ANRS 1265)

Observational studies suggest that male circumcision may provide protection against HIV-1 infection. A randomized, controlled, intervention trial was conducted in a general population of S...

Evaluation of the Extension at Community Level of Safe Male Circumcision (ANRS 12126 ORANGE FARM 2)

This study is aimed at demonstrating whether or not Male Circumcision can be used as an effective public health prevention tool that will have an impact on HIV prevalence in the South Afri...

PubMed Articles [5045 Associated PubMed Articles listed on BioPortfolio]

Male Circumcision for the Prevention of HIV Acquisition: A Meta-Analysis.

To assess male circumcision for the prevention of HIV acquisition in heterosexual and homosexual men using all available data. Previous meta-analyses suggest that circumcision is effective at reducing...

A novel disposable circumcision device versus conventional surgery in the treatment of redundant prepuce and phimosis.

To compare the clinical effect of a novel disposable circumcision device Ring with that of conventional circumcision in the treatment of redundant prepuce and phimosis.

A novel disposable ring versus the suture device in circumcision.

To investigate the clinical effect of a novel disposable ring versus that of the suture device in circumcision for redundant prepuce and phimosis.

The evolutionary saga of circumcision from a religious perspective.

Circumcision is the oldest surgical operation known to mankind. It probably originated as a less radical form of genital mutilation inflicted on prisoners of war. Over time it was adopted by the Egypt...

Field evaluation of the safety, acceptability, and feasibility of early infant male circumcision using the AccuCirc device.

As countries scale up adult voluntary medical male circumcision (VMMC) for HIV prevention, they are looking ahead to long term sustainable strategies, including introduction of early infant male circu...

Medical and Biotech [MESH] Definitions

Excision of the prepuce of the penis (FORESKIN) or part of it.

A general term encompassing three types of excision of the external female genitalia - Sunna, clitoridectomy, and infibulation. It is associated with severe health risks and has been declared illegal in many places, but continues to be widely practiced in a number of countries, particularly in Africa.

The tunnel in the lower anterior ABDOMINAL WALL through which the SPERMATIC CORD, in the male; ROUND LIGAMENT, in the female; nerves; and vessels pass. Its internal end is at the deep inguinal ring and its external end is at the superficial inguinal ring.

MYCOBACTERIUM infections of the male reproductive tract (GENITALIA, MALE).

Pathological processes involving the male reproductive tract (GENITALIA, MALE).

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