Today CEO of Platigo Solutions Pty. limited, Andrew James, announced that "the Novoglan Clinical Trial has been approved by Macquarie University and the Macquarie University Private Hospital. This first in word clinical trial for a patented Australian designed and manufactured medical device to treat Phimosis, is a major step in gaining clinical trial quality evidence to support recommendations to change the treatment guidelines for adult phimosis." Mr James said that "between 2% to 3% of men with an intact foreskin will suffer from phimosis, an abnormal tightening of the foreskin, at some stage of their life."
Mr James James said that; "Traditionally, treatment for phimosis has been to recommend circumcision (the complete removal of the foreskin). In recent years the European Urology fraternity has moved towards patient centred medicine and that has led to many adult phimosis sufferers wanting to keep their foreskin and all the benefits that it provides. The European Urology fraternity is keen to get clinical trial level evidence for Novoglan so that they can prescribe Novoglan as a first line treatment."
Dr Huber Mazure, the Chief Clinical Trial Consultant working on the Novoglan trial, says that "Novoglan is a patented class 1 medical device and has been sold into countries all over the world with tens of thousands of kits sold to date. Real world post marketing surveillance studies have demonstrated excellent safety and tolerability with the Novoglan device." Dr Mazure says that "the Macquarie University Clinical trial will add critical independent efficacy data to support clinician decision making. The principle investigator is world renowned Urologist Professor David Gillatt:"
Some key points about the trial:
- The clinical trial will be independently run by Macquarie University with Professor David Gillatt (Professor - Director of Medical Services, MQ Health, Faculty of Medicine and Health Sciences
- Professor Gillatt is a Specialist Urology Clinician & Surgeon at the Macquarie University Hospital
- The Clinical Trial commences on September 2, 2019 and the Clinical team will be seeking men aged 18 years and older who have a tight foreskin. There is no cost to the patient and they will receive state of the art care whilst in the trial.
- Patients will travel to Macquarie University Hospital Clinic at North Ryde near the Macquarie Shopping centre. Travel costs and parking will be covered by the University.
- How to find out more? If anyone is interested or knows someone who may suffer from phimosis in or around Sydney, they should contact the Macquarie University Clinical trial project manager Maizie Barakat at Macquarie University Hospital on phone 02 9812 3031 or email Maizie.Barakat@muh.org.au
Mr James went on to say that "men who were circumcised as an infant do not realise what they have lost and what impact the loss of the foreskin has on the health of their glans and the impact it has on their partner. Significant evidence has now emerged that supports the growing desire of men to keep their foreskin intact and avoid surgery where possible. Please pass this information on to anyone that may have phimosis and is looking for non surgical treatment options."