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Research

Clinical Research

In addition to expanding our knowledge by research into patient outcomes, the Institute of Weight Control is also involved in a number of clinical trials. Before any new drug, device or surgery makes it to market it goes through a series of stringent clinical trials.

A clinical trial is a research study conducted with patients who have been diagnosed with major illness and generally involves testing of new treatments (whether drugs or devices) or finding ways of improving existing treatments. Clinical trials are conducted all over the world in most large hospitals and institutions in an attempt to improve treatment for many diseases. The main objective of a clinical trial is to compare two or more groups of subjects, using two or more treatment options to determine the effectiveness of a proposed drug or biological treatment.

Clinical trials are carefully and ethically designed to allow truthful and precise collection and analysis of information to find out more about a disease. Such trials help discover whether a promising new treatment is safe and effective, as well as giving a better understanding of the current standard treatment, in the hope of improving the side effects experienced by many patients.

Ethics Approval

  • All research and clinical trials conducted by IWC are approved by the Bellberry Ethics Committee (www.bellberry.com.au).
  • Human research ethics committees are set up by the Government and the National Health and Medical Research Council of Australia to review all research and ensure that it meets the ICH-GCP (International Conference on Harmonisation and Good Clinical Practice) standards and guidelines.
  • Bellberry ethics committee ensures that "all kinds of research involving or impacting on humans conforms to the highest standards of ethical practice and academic integrity".

Clinical Studies

Implantable Vagal Block Therapy (VBLOC) as a Treatment for Obesity

VBLOC™ Therapy is designed to precisely control, or "neuroregulate", nerve and organ function. The vagal nerves regulate much of the activity of the stomach and believed to play a significant role in the signaling of satiety and hunger.

VBLOC Therapy delivers high frequency, low energy electrical signals through laparoscopically implanted leads to block vagal nerve transmission. The delivery of energy to the nerves is intermittent and the effects of VBLOC Therapy on the nerves and end organs are intended to be reversible. The system is designed to be precisely programmed and non-invasively adjusted to meet individual needs. Unlike the majority of existing surgical obesity treatments, normal digestive system anatomy is preserved. Clinical trials are intended to show that VBLOC Therapy will help those who are morbidly obese manage their weight.

Currently available surgical obesity treatments such as gastric bypass surgery and laparoscopic banding alter normal anatomy to reduce stomach size. Clinical studies will demonstrate if VBLOC Therapy offers a safe and effective alternative to the well known complications associated with existing approaches to bariatric surgery.

Enrolment for all VBLOC clinical trials have now been completed. If you would like further information please contact Radhika on 96391033 or email her on clinicaltrials@circleofcare.com.au

A: "The RECHARGE clinical trial"

Protocol number: D01088-000

Aim: To determine the safety and efficacy of the Maestro Rechargeable System (RC2) in producing weight loss in obese subjects

Study Design:

  • Prospective, randomized, blinded, multi-center trial
  • All subjects will receive an implanted device and will be randomized in a two to one allocation to treatment or control groups
  • The control group will have a non-active device that will deliver no charge to the vagus nerve as the comparison group
  • All subjects will participate in a weight management program, consisting of recommendations regarding diet, exercise, and behavior modification throughout the study
  • All subjects will receive blinded therapy through the 12-month follow-up visit, after which all subjects who were randomized to the control group will have the option to have a complete Maestro Rechargeable System implanted and receive therapy
  • 5 year duration

B: VBLOC Type 2 Diabetes Sub Study

Protocol number:  D00343-00

Aim: To evaluate short and long term glycaemic control in obese patients with type 2 diabetes using the Maestro Rechargeable System.

Study Design:

  • Prospective, multi centre trial
  • All subjects will receive an implantable device
  • All subjects need to have had a diagnosis of type 2 diabetes within 5 years
  • All subjects to participate in a weight management program
  • 5 year duration with a 2 year extension

C: The "EMPOWER" clinical trial: Vagal Blocking for Obesity Control

Protocol number: D00343-00

Aim: To determine the safety and efficacy of the Maestro RF2 System in producing weight loss in obese subjects

Study Design:

  • Prospective, randomized, double-blind, parallel-group, multi-center trial
  • All non-diabetic subjects will receive a Maestro System implant and will be
  • Randomized in a two to one allocation to receive either therapy ON or therapy OFF
  • All subjects will participate in a weight management program, consisting of recommendations regarding diet, exercise, and behavior modification throughout the study
  • All subjects will receive blinded therapy through the 12-month follow-up visit, after which all subjects who were randomized to the therapy OFF group will have therapy turned ON
  • 5 year clinical trial with a two year extension
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