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Trial enrolment

Obalon completes US trial enrolment for balloon therapy

Strong interest by patients and physicians resulted in full enrolment of the clinical trial in 62 days

Obalon Therapeutics has completed patient enrolment for its multi-centre US pivotal trial of the Obalon balloon, a nonsurgical, fully-reversible device for weight loss. The trial utilises Obalon's most recent technology advancement that facilitates a six-month treatment period with the gas-filled balloon. Obalon expects the data from the trial necessary to file for approval with the FDA by the end of 2015.

Strong interest by patients and physicians resulted in full enrolment of the clinical trial in 62 days. More than 24,000 patients visited to inquire about participation in the trial.

"To have reached full enrolment with all 15 sites only four months after receiving Investigational Device Exemption (IDE) approval from the FDA is very exciting and is a testament to the commitment of the teams at our clinical trial sites and Obalon employees," said Andy Rasdal, chief executive officer of Obalon.

The Obalon balloon is designed to jump-start weight loss by partially filling the stomach and helping to induce a feeling of fullness to help people eat less. The patient swallows a capsule containing a balloon, which is attatched to a micro-catheter. Once the capsule arrives in the stomach, the outer layer dissolves. The balloon is then simply inflated to the size of an apple, through the micro-catheter, without the need for an endoscopy or sedation.

Once inflated, Obalon sits comfortably at the top of the stomach sending messages to the brain to decrease the feeling of hunger, which encourages reduced food consumption and calorie intake. Following a healthy eating plan in conjunction with Obalon ensures enhanced weight loss. Unlike other balloon treatments, there is no need to eliminate certain foods; you simply eat less due to a reduced appetite, the company claims.

Additional balloons are placed to continue to facilitate weight loss during the treatment period and are removed at the end in a short endoscopic procedure.

The Obalon balloon is not approved in the US and is available for investigational use only. The Obalon balloon is approved for sale in the European Union, Mexico and the Middle East.

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