TRIAL STUDY INFORMATION

We are running a trial using a surgical device that is currently under investigation so is not available for human use outside a clinical trial. The device has been used in over 85 patients worldwide and appears as safe as other currently used surgical methods.

Eligible patients, who have undergone medical screening will be offered the procedure as part of a clinical trial.

While we cannot foresee what results or outcomes may occur for people in the trial, these types of surgeries can allow patients to lose around 15% of their starting weight by a year after surgery, and an improvement in weight, or Obesity related conditions such as Type II diabetes.

Who is eligible for the study?

Patients with weight regain after previous sleeve gastrectomy surgery, and or patients with Type II
diabetes.

What does the surgery involve?

It’s a combined endoscopy and laparoscopy procedure which involves creation of a bypass between the duodenum and the distal small bowel, otherwise known as a duodeno-ileostomy.

This leads to a change in hormones associated with eating as well as absorption of calories from food.

Both of these together helps cause weight loss however they can also lead to diarrhoea and nutrient deficiencies if not combined with dietary change and vitamin/mineral supplements.

How long is the hospital stay?

1 night in Hospital and 1 week off work.

What else does the study involve?

Patients who wish to find out more about the study are invited to fill in a screening questionnaire
(below), and those who meet the criteria will then be invited in for a face-to-face medical assessment and a further discussion about what the study involves.

While medical costs for the surgery and pre and post operative care will be covered for 12 months,
there is a requirement that patients be available to come in for follow-up at regular intervals for 7 post-procedure appointments over 12 months.

What are the risks?

All surgeries have potential risks relating to anaesthesia and other medications used.

Surgical risks include those of bleeding and infection, and patients having Bypass surgeries all need to take vitamin supplements lifelong after surgery. Risks such as diarrhoea and excessive weight loss are also possible.

While patients having Bypass procedures usually lose weight, not all do.

What is the criteria to be eligible?

Age:
– Between 18-65 years

 

BMI:
-Between 30-50 kg/m2

Inclusion Criteria:

T2DM following previous sleeve gastrectomy; T2DM without previous sleeve gastrectomy and without plan to perform a concurrent sleeve gastrectomy; weight regain following previous sleeve gastrectomy

Additional information

Additional information is available on the GT Metabolic website.

VIEW HERE

EXPRESION OF INTEREST

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Eligibility

Contact Us

Are you interested to know more? Contact our team.