HybridAPC in GMA - Obesity Clinical Trial @ The BMI Clinic

The HybridAPC in GMA Clinical Study is a research project being conducted at The BMI Clinic, investigating a potential new treatment for obesity called Gastric Mucosal Ablation (GMA).

GMA is a minimally invasive procedure that is performed using an endoscope (a long tube with a camera) that is inserted into the stomach through the mouth without the need for external incisions (cuts) or scars.

This clinical study is being conducted to assess feasibility and safety of GMA as an obesity treatment.

What is the purpose of this research?

Laparoscopic sleeve gastrectomy (LSG), also known as gastric sleeve surgery, is one of the most common surgical methods performed for the treatment of obesity. It involves the removal of most of the stomach so that the size of the stomach is reduced.

Research suggests that the weight loss effect of LSG is not only due to the smaller size of the stomach, but also due to the hormonal changes that result from the removing those parts of the stomach. These hormonal changes result in changes in the metabolism of sugars and fats that promote weight loss.

The hormonally active part of the stomach is found only within the internal lining of the stomach. The purpose of this study is to assess whether a well established treatment, known as Argon Plasma Coagulation (APC) can be used to treat obesity by destroying the hormonally active lining while leaving the rest of the stomach intact.

While APC has been in use around the world for decades, this is the first time APC will be used to treat most of the stomach (approximately 70%) and is the first time this is being done specifically targeting weight loss. The use of APC in this manner is referred to as Gastric Mucosal Ablation, or GMA, and this study is being done to assess the safety and feasibility of GMA.

What is Gastric Mucosal Ablation (GMA)?

A special instrument, called HybridAPC, is passed through the endoscope and into the stomach and uses electricity to create a stream of heated argon gas (plasma), which is applied to the stomach lining resulting in the destruction of this lining. HybridAPC is currently used routinely in clinical practice during the endoscopic treatment of gastrointestinal (GI) diseases.

As an obesity treatment, GMA is an experimental technique. This study will be a first-in-human study, which means this is the first time that GMA is being tested for feasibility and safety in humans.

What does participation in this clinical trial involve?

Once enrolled in the study, participants will have around 60% to 70% of their stomach lining treated with Argon Plasma, split over two treatment sessions approximately 8 weeks apart.

Participants will be enrolled in the study for approximately 9 months in total, during which time your doctor will monitor your progress through regular consultations. You will also be supported by a dietitian who will provide advice to assist you with weight loss. A range of blood tests, scans, questionnaires and an endoscopy will also be performed to keep track of your progress.

It is important to understand that you will be required to attend our clinics regularly (approximately 10-12 occasions) throughout the 9 month enrolment period.

Who is Eligible to Participate?

You may be considered for this study if:

• your BMI is between 30 kg/m² and 45 kg/m²

• you are between 18 and 75 years of age

• you have not undergone bariatric surgery or endoscopic bariatric therapy

• your weight has been stable (defined as a fluctuation of less than 5%) for at least 3 months

• you meet all eligibility criteria as assessed by your study doctor.

Please register your interest today for a full list of inclusion and exclusion criteria. Our study team will contact you to help determine whether you may be eligible.

What are the possible benefits and risks of taking part?

GMA is an experimental procedure and this study is designed to assess the feasibility and safety of the procedure as a weight loss intervention.

Because this is the first time this procedure will be performed in humans, we cannot guarantee or promise that you will receive any benefits from this research, however, possible benefits may include that you experience weight loss. Your participation may also support the development of GMA as a minimally-invasive treatment option for obesity in the future.

As GMA of stomach tissue has not been performed in patients before, all of the potential risks and side effects are not yet known.

Based on our knowledge of the risks that are possible and those that have been observed in similar treatments, the most common side effects are expected to be symptoms related to anaesthesia and the endoscopic procedure, such as sore throat, stomach discomfort, nausea, vomiting etc. They are expected to be temporary and mild in severity. Additional risks and side effects of the GMA Procedure may include, but are not limited to:

- Short-term nausea and abdominal pain.

- Increased risk of perforation (a hole in the stomach) and/or bleeding and/or stomach ulcers.

A more detailed list of potential risks and side effects are available from the study team and will be discussed with you by the study doctor.

Although the gastric mucosa is expected to heal after the procedure, the GMA procedure is expected to be irreversible.

Why Participate?

If you’re struggling with obesity and interested in a new way to potentially lose excess weight, you may be a candidate for the HybridAPC in GMA Study.

If you qualify and choose to join the HybridAPC in GMA Study you will receive:

• Evaluations and support from a local doctor specialising in obesity.

• The GMA Procedure and study-related care at no cost.

• Dietitian counseling to help you with weight loss.

• Compensation for your time and travel to attend follow-up visits over a 9-month period to monitor your progress.

Who is conducting the research project?

The HybridAPC in GMA Clinical Study is being conducted by Dr. Adrian Sartoretto (Principal Investigator) and the team at The BMI Clinic in Sydney.

The BMI Clinic is Australia's largest and most experienced endoscopic weight loss centre with more than 15 years of experience.

Dr Sartoretto is the Medical Director of The BMI Clinic, and is responsible for overseeing the development and implementation of our suite of weight loss programs. Recognised as being a leader in this field, he contributes regularly to research and is an investigator in a number of clinical trials examining novel devices and therapies in the emerging field of bariatric endoscopy.

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