Endolumik’s fluorescence guided Gastric Calibration Tube, which uses near infrared (NIR) light to allow surgeons to more clearly visualize surgical tools inside the stomach and help them avoid adverse events that can be caused by poor visualisation, has received FDA 510(k) clearance. The device was designated by the FDA as part of their Safer Technology Program (STEP), the first device ever approved through the programme. According to the FDA, the STEP programme is for devices that are "reasonably expected to significantly improve the safety of currently available treatments."
“Endolumik’s bougie brings light to the blind aspect of the procedure,” said Dr Dan Azagury, the Chief of Minimally Invasive & Bariatric Surgery at Stanford University School of Medicine. “Allowing surgeons to visualise the bougie through the gastric wall will remove the guessing or estimating portion of the procedure. Relying on direct visualisation has the potential to improve the safety and consistency of the procedure.”
Endolumik Gastric Calibration Tube is currently being assessed in a pilot study, the First In Human Clinical Trial, to evaluate the and associated methods in a human clinical cohort of 20-30 bariatric patients at two high-volume bariatric cenres. During this clinical study, the single-use, disposable Endolumik Gastric Calibration Tube will be used during twenty sleeve gastrectomy operations and gastric bypass operations. Up to twenty participants meeting inclusion criteria will undergo laparoscopic or robotic sleeve gastrectomy using the Endolumik Gastric Calibration Tube instead of the standard bougie calibration tube. Up to ten participants meeting inclusion criteria will undergo laparoscopic gastric bypass using the Endolumik Gastric Calibration Tube instead of the standard calibration tube.
The portions of the sleeve gastrectomy operation where the Gastric Calibration Tube will be used include:
To evacuate gastric contents
During construction of the gastric sleeve
To perform the leak test of the gastric sleeve Up to ten participants will undergo laparoscopic gastric bypass using the EGCT.
The portions of the gastric bypass operation where the Gastric Calibration Tube will be used include:
To evacuate gastric contents
During construction of the gastric pouch
To calibrate closure of the gastrojejunal anastomosis
To perform a leak test of the gastrojejunal anastomosis
“Our mission is to provide surgeons with additional visual cues to succeed in the operating room,” said Dr Nova Szoka, the Chief Medical Officer of Endolumik. “We believe the enhanced visualisation that our device provides will help surgeons standardise surgical outcomes for sleeve gastrectomy, and this will translate to improved patient outcomes.”
The technology also has the potential to expand the use of surgical robotic applications. With FDA 510(k) clearance, Endolumik will begin real-world clinical use of the Gastric Calibration Tube with select hospitals and health systems in the 2nd quarter of 2023.