Professor Neil Piller,
                    Clinical Trials Lymphedema.

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Professor Neil Piller.

Meet Professor Neil Piller - Lymphologist and Team Leader of the Lymphedema Assessment Clinic:

Prof. Piller works at the Flinders University Medical Center in South Australia and specializes in clinical and experimental research on primary and secondary lymphedemas and edemas, their assessment, treatment and management.

He belongs to the Australasian Lymphology Association and the Lymphedema Association of Australia and is the Patron of the Lymphedema Support Group of South Australia.

Prof Piller.  --- Clinical
                      trials

Prof. Piller conducted the clinical trials for HTE's Sun Ancon Chi Machine.

"Professor Piller along with Dr Stephen Birrell established the Lymphedema Assessment Clinic in 1993. The Clinic specializes in the assessment and differential diagnosis of lymphedemas, edemas and lipoedemas.

The Clinic uses a range of assessment tools such as perometry, bio-impedance and tonometry to objectively determine tissue changes and as the basis of the diagnosis. The Clinic reviews patients from across Australia and overseas and as an outcome presents patients with a comprehensive treatment and management plan." - Flinders University Medical Center.


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Flinders
                        University

Prestigious Flinders University,
Adelaide, South Australia.

Background Info:
Flinders Medical Devices and Technologies (FMDAT) - Member Neil Piller.
Research, Develop, Apply and Commercialize Medical Devices & Technologies:

- Internationally recognized lymphologist.
- Part of an international network of researchers in lymphological disorders.
- Director and team leader of a multi-disciplinary team of researchers.
 
- Consultant and adviser to government, professional and industry groups.
- Published and presented over 300 articles including in Lymphology, New England Journal of Medicine, Australian Doctor, Medicine Today.
 
- Regular presenter and invited speaker at international meetings, the most recent being the International Society of Lymphology meeting in Germany, the British Lymphology Society meeting in Glasgow, Vein meeting in Auckland and Phlebology meeting in Sydney.

- Editor/Reviewer of international journals including, Lymphatic Research and Biology, US-China journal of Oncology and Lymphology, medical science monitor.
 
- Involved in screening programs for early detection of soft tissue changes in chronic disorders such as lymphedema, edemas and lipoedemas.
 
- Interested in the early detection and treatment of superficial tissue diseases and disorders.
 
- Developed techniques for the measurement of fibre and other changes in superficial tissues.
 
- Very strong commitment to patient and practitioner awareness raising and education.
 
- Runs a range of course for patients and health professionals in the areas of edemas/lymphedemas and their recognition.
 
- Recipient of over $1.6 million in Industry, Government and other grants in recent years.
 
Flinders University Medical Center website.

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Contract between Flinders University and HTE.

Flinders trial.

15th June 2000

Gordon Pan of HTE with Louise Hicks,
Chairperson of Flinders University.


Clinical trials are concluded:
March 28 - April 8, 2002.

Researchers from the Department of Public Health Lymphedema Assessment Clinic and Flinders Biomedical Engineering recently concluded trials on behalf of Hsin Ten Enterprises (HTE), a Taiwanese-based company.


Flinders team.

January 2002
Amanda Moseley, Prof. Neil Piller, Louise Hicks,
Dr. S. Birrell and Jerry Tsai (CEO of Hsin Ten).

The team of researchers was headed by Professor Neil Piller, a specialist in the treatment of edemas, medical conditions that result in swelling of the legs through fluid retention.

Loss of fluid and a reduction in the pain and swelling were among the results observed and evaluated over 21 days use of the machine by edema sufferers. The research work was a feature of a ABC television program.

A recent function marked the conclusion of the project, and final results of the trial were presented by Flinders Consulting Chairman Ms Louise Hicks to Mr Jerry Tsai, President of Hsin Ten.

In recognition of the researchers' efforts, Mr Tsai donated 20 of the company's Aerobic Exerciser machines to the Lymphoedema Assessment Clinic for further research and for selected use by suffers of edemas. Hsin Ten representatives from both Taiwan and Sydney attended the function, and further collaborations with Flinders were discussed.

Dr. Wayne Harvey, Managing Director of Flinders Consulting, said it was gratifying to see the increase in use and recognition of expertise offered by university researchers. "The skills of university staff are increasingly being applied to commercial opportunities with community benefits," Dr Harvey said. - Flinders University, www.flinders.edu.au
 

Flinders
                        booklet.

Flinders Booklets.

Flinders University independently produced 3 medical booklets detailing the research finding:

1) Secondary Lymphedema.
2) Venous Edema.
3) Patient follow-up.

The booklets contain a condensed report of the findings of the large scale clinical trial contracted out to Professor Piller on behalf of Hsin Ten by Flinders Consulting, as well as providing instructions for the reader on how to take optimum care of their legs, with additional guidance regarding the types of treatments that may be available to them.

Flinders University also produced an interactive DVD for educating professionals and patients about the lymphatic system and the clinical trial results. It features the Sun Ancon Chi Machine as an option of treatment.

"The Vital Essence: Understanding the lymphatic system in health and disease" DVD, is only available from Flinders University.

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Significance of Clinical Trial:

Piller chi machine cinical
                      trials.Piller letter clinical trials.


May 30th 2002:

Letter from Prof. Neil Piller regarding the significance of clinical trial results for the HTE Sun Ancon Chi Machine.

Extracts:

1) "Between 2000 and 2002 a large scale Clinical Trial was conducted at Flinders Medical Center on two groups of patients, one group with chronic leg Secondary Lymphedema and one group with chronic leg Venous Edema."

2) "It is obvious that the Sun Ancon Aerobic exerciser has a very significant impact on chronic limb swelling associated with failure of the lymphatic systems and compromised vascular systems combined with an overloaded lymphatic system even when used in the patient's home for 3 weeks.

Given that some of the patients have had their problems for up to 30 years and that they were generally (to the time of the trial) receiving the best current treatments without great impact, these trial findings offer considerable hope for this group of patients."

3) "It would seem that continued use might be able to achieve better results, as is evidenced by the one-month follow-up findings. However perhaps more important is that this form of home based treatment was commented on by the participants as giving them confidence and self determination in managing their problem (which previously they seemed not to have).

It would also seem that this treatment is a cost-effective means of managing these problems, reducing the need to see physiotherapists or otherwise use the health care system for their conditions."

4) "The trial results have been presented at the International Congress of lymphology meeting in Genoa in 2001 and are about to be published in the medical literature now the study is complete."


Flinders University References: 
New deal sees Flinders team conduct trials for Taiwanese company, Hsin Ten (HTE).
http://www.flinders.edu.au/news/articles/?oc12v09s01

Projects and clients.
www.flinders.edu.au/ResCons/consult/projects.htm

Equipment trials come up trumps.
www.flinders.edu.au/news/articles/?oc04v11s04


Flinders University Clinical Trial Results
The Sun Ancon Chi Machine clinical trials and the results.

Lympedema and Venous Edema
Clinical Trials and Personal Experiences.


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Chi Machine clinical trials
published articles:

Flinders University published their clinical trial results in two medical journals.

1) Australian and New Zealand, 'Phlebology', November 2003

2) 'Lymphology', December 2002, and 'Lymphology', June 2004

Phlebology

1) The Impact of the Sun Ancon Chi Machine Aerobic Exercise on Chronic Edema of the Legs.

- Moseley, A.L., Piller, N.B., Esterman, A.J. and Carati, C.J. (November 2003). The impact of the sun Ancon aerobic exerciser on chronic oedema of the legs. Australian and New Zealand Journal of Phlebology, 7(2) pp. 5-10.

Lmphology

2) The Sun Ancon Chi Machine Aerobic Exerciser: a new patient focused, home-based therapy for people with chronic secondary leg lymphedema. 

"A significant proportion of those who survive lower torso cancer treatments will go on to develop clinically discernible bilateral or unilateral leg lymphedema. Although beneficial treatments exist for this condition, many are expensive and involve visits to outpatient clinics or allied health professionals - making the patient dependent upon others for treatment and maintenance.

This clinical trial tested the efficacy of the Sun Ancon Chi Machine Aerobic Exerciser, a home based therapy that delivered both elevation and passive exercise to the legs. This machine was used in the participant's home according to a set regime with measurements being taken immediately before trial commencement, at weekly intervals and then 1 month after treatment cessation.

After a three week treatment period there were statistically significant reductions in total leg volume and fluids, whole body extracellular fluid, weight and subjective leg symptoms. Lymphscintigraphy in a sub-group of patients suggested an increase in lymphatic transport in some individuals.

Although some of the fluid and symptoms had returned at the 1 month follow up, none of the parameters had returned to pre-treatment levels.

This finding indicates that this equipment may have ongoing beneficial effects. This clinical trial demonstrates that the Sun Ancon Chi Machine Aerobic Exerciser is an effective adjunct therapy that can be used in the patient's own home."

- Department of Surgery and Lymphoedema Assessment Clinic, School of Medicine, Bedford Park, South Australia, Australia. Lymphology. Issue 37, June 2004, p.43-4 - Moseley AL, Piller N, Esterman A, Carati C.

Sun Ancon Chi
                        Machine SDM-888

Original Sun Ancon Chi Machine
Proven to reduce leg lymphoedema.

2b) Combined opto-electronic perometry and bioimpedance to measure objectively the effectiveness of a new treatment intervention for chronic secondary leg lymphedema.

"Secondary lymphedema of the legs is a common sequela of patients treated for cancer of the reproductive, gastrointestinal, urinary systems and melanoma. From a clinical and research perspective it is of utmost importance to use techniques that objectively quantify leg volume and fluid composition as an indicator of lymphedema severity and response to treatment.

Two techniques often used in both the clinical and research setting are leg perometry and multi-frequency bioimpedance. Although both techniques have been extensively validated, this trial aimed to cross correlate both measurement techniques to ascertain whether each or both could be used reliably for measurement of leg lymphedema.

These measurements were utilized throughout a clinical trial that assessed the effectiveness of a new home based treatment program in the form of the Sun Ancon Aerobic Exerciser. This machine delivered both elevation and passive exercise to the legs, with participants using the machine over a three week period during which time their leg volumes were measured using both perometry and bioimpedance.

The results demonstrated that leg volume measurements decreased using both perometry and bioimpedance. The reduction in body extracellular fluid as measured by bioimpedance correlated well with a reduction in leg volume as measured by perometry. Bioimpedance also recorded a reduction in weight, which was correlated with the reduction in leg volume as measured by perometry.

This trial confirms that perometry and bioimpedance were both effective in independently showing a reduction in leg lymphedema using the Aerobic Exerciser therapy, and that both methods can be reliably used to measure and follow leg lymphedema."

- Lymphedema Assessment Clinic, Flinders Surgical Oncology Unit, Department of Public Health School of Medicine, Flinders Medical Centre, Bedford Park, Adelaide, South Australia. Lymphology. Issue 35, December 2002, p.136-43 - Moseley A, Piller N, Carati C.



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