Medical technology firm Obalon Therapeutics has completed the enrollment of patients in a US pivotal trial of the new weight loss balloon.
Obalon balloon is being developed as a nonsurgical and fully-reversible device for weight loss.
According to the firm, the trial uses its most recent technology advancement that facilitates a six-month treatment period with the gas-filled balloon.
The company will use data from the trial to file for approval with the US Food and Drug Administration (FDA) by the end of this year.
Obalon CEO Andy Rasdal said: "To have reached full enrollment 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."
The Obalon balloon has been designed to jump-start weight loss by partially filling the stomach and aiding to induce a feeling of fullness to help people eat less.
The patient swallows a capsule containing a balloon that is then inflated with gas in the stomach and additional balloons are placed to continue to facilitate weight loss during the treatment period. These are removed at the end in a short endoscopic procedure.
The Obalon balloon has not yet received approval in the US and is available for investigational use only. It received approval to market in the European Union, Mexico and the Middle East.