How many subjects are in the study?

The OTTER Study intends to enroll between 300 and 420 children. 

Is this treatment approved by the FDA?

The study procedure is investigational only, and is not currently approved.

Have there been other studies evaluating this procedure?

Several studies were previously conducted. The most recent study, called INOVA, has a publication of the clinical results (click here), and a publication regarding the pediatric stress during the procedure (click here). The INOVA study used a different version of the numbing medicine, and so the safety and efficacy of the product to be used in the OTTER study has not been established.