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The PrePex is a WHO prequalified medical device for adult male circumcision for HIV prevention. The Government of Rwanda was the first country to implement the PrePex and acts as the leading Center of Excellence providing training and formal guidelines.
In support of efforts to scale up male circumcision, readily available data have been applied to estimate the potential cost and impact of scaling up medical MC services in Rwanda to reach 80 percent of adult, children and newborn males by 2015. Infant and children male circumcision ensures that the wound will be healed before sexual activity begins, and thus reduces the risk of HIV transmission during healing period.
The American Academy of Pediatrics (AAP) published in August 2012 a technical report and a policy statement, "Evaluation of current evidence indicates that the health benefits of new-born male circumcision outweigh the risks; furthermore, the benefits of newborn male circumcision justify access to this procedure for families who choose it. Specific benefits from male circumcision were identified for the prevention of urinary tract infections, acquisition of HIV, transmission of some sexually transmitted infections, and penile cancer. Male circumcision does not appear to adversely affect penile sexual function/sensitivity or sexual satisfaction. It is imperative that those providing circumcision are adequately trained and that both sterile techniques and effective pain management are used. Significant acute complications are rare."
The primary objective of the study was to assess the safety and efficacy of the PrePex device among healthy early infant and children males scheduled for voluntary circumcision. The study consisted of 2 phases:
Phase I included infants age 5-33 days Phase II included children age 4-10 years.
The study examined the feasibility of performing PrePex circumcision on early infants and children male population.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Medical Device Complication
Male circumcision using a non-surgical device
Rwanda Military Hospital
Ministry of Health, Rwanda
Published on BioPortfolio: 2014-11-25T06:53:21-0500
This is a single-arm interventional study of 1000 male circumcision procedures using the ShangRing device. The primary objective of the study is to enhance understanding of the potential c...
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...
This prospective study will evaluate the safety and acceptability of the ShangRing device for medical male circumcision (MMC) during routine service delivery in Namitete, Malawi
To assess the safety and acceptability of the non-surgical PrePex device among healthy adult male participants scheduled for voluntary medical male circumcision when removing the foreskin ...
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...
To investigate the clinical effects of circumcision by surgical plane positioning with a disposable circumcision suture device in the treatment of phimosis and redundant prepuce.
Objective To evaluate post-operative complications of circumcision requiring surgical reintervention. Methods Retrospective analysis of medical records of patients submitted to circumcision from May 1...
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.
To investigate the clinical effect of a novel disposable ring versus that of the suture device in circumcision for redundant prepuce and phimosis.
This article refreshes the innovative review approach of medical device in China at first. It proposes reference through presenting a series of existing review and approval of innovative medical devic...
Removal of a MEDICAL DEVICE from the market due to the identification of an intrinsic property of the device that results in a serious risk to public health.
Removal of a MEDICAL DEVICE from the market due to a problem occurring in the manufacture or distribution of the product.
Device designed to wear externally to support muscular skeletal system in various movements such as RANGE OF MOTIONS; WEIGHT-BEARING; GAIT; and LOCOMOTION.
The shifting in position or location of an INTRAUTERINE DEVICE from its original placement.
Removal of an implanted therapeutic or prosthetic device.
The role of medical devices in healthcare is essential. The diversity and innovativeness of this sector contribute significantly to enhance the quality and efficacy of healthcare. Covering a wide range of products, from simple bandages to the...
Human Immuno Deficiency Virus (HIV)
Human Immunodeficiency Virus (HIV), the causative agent of AIDS. The Human Immunodeficiency Virus, more commonly known as HIV, is a member of the lentivirus sub-set of the retrovirus family of pathogens. It causes AIDS, or Acquired Immuno Deficiency Sy...