UPDATED: FDA smacks EndoGastric Solutions with warning over study violations

U.S. regulators are taking EndoGastric Solutions to task over a number of alleged violations concerning an ongoing clinical study the company apparently placed on hold without ever telling regulators why. The company is testing treatments that address chronic acid reflux.

The FDA's June 8, 2012 warning letter to EndoGastric CEO Michael Kleine addresses a randomized controlled trial for the company's StomaphyX technology. Regulators base their citations on a visit to the company's Redwood City, CA, facility from Feb. 10-29, 2012.

FDA officials blasted EndoGastric for not providing information they needed to conduct their investigation properly and for not following its own monitoring schedule for subjects as specified in its study protocol. More importantly, however, EndoGastric Solutions is under FDA scrutiny for failing to inform regulators at all and waiting months to tell its institutional review board that its trial was placed on hold in 2010 because of "questionable effectiveness of the investigational device" involved.

The FDA said that the delay in notifying the company's IRB and avoiding telling regulators at all about the trial delay involved "clinically-significant violations" that put human trial subjects at risk and could have compromised their safety as well as the quality of data.

EndoGastric is currently conducting three clinical trials in the U.S. and one in Europe, according to its website. The company had 15 working days after receiving the warning letter to respond and outline actions it will take to address any violations and prevent problems from recurring.

Separtely, EndoGastric got FDA clearance for its EosphyX device, unrelated to StomaphyX, in 2007. EosphyX is designed for use with the Transoral Incisionless Fundoplication procedure to help rebuild the gastroesophageal valve's ability to block acid reflux. There are no incisions involved and it is implanted through the mouth. Earlier this summer, EndoGastric raised $13 million in additional venture financing, in part to pursue additional clinical testing and R&D programs to support use of the TIF procedure and related technology.

- read the FDA warning letter

Editor's note: This story is updated to more clearly state the technology behind the warning letter. An earlier version of this story incorrectly inferred another technology might be involved. We regret the error.