Off-Label Gel Use in First-In-Human Implant Study

[MedicalResp]

We have a Class III implant intended for use in a first-in-human study. The surgical procedure involves percutaneous implantation. To reduce friction during implantation, we are considering using "off-the-shelf" lubricant gels. Although the part of the device that comes into contact with the gel will be removed, some gel will inevitably remain inside the body.

We are evaluating two types of technically suitable commercial gels (both are sterile and biocompatible):

1. Wound dressing hydrogels indicated for "for partial and full thickness wounds including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree bums, abrasions, lacerations, skin tears, grafted wounds, donor sites and surgical wounds."
2. Lubricating gels indicated for "facilitating the entry of a diagnostic or therapeutic device into a body orifice by reducing friction between the device and body."

I am seeking an advice on whether and how it might be possible to use one of these gels "off-label" during the first-in-human study.
To clarify, the use of the gel will not be part of the final product, but we need a solution for this early feasibility stage.
Is there any scope for applying a rational approach or conducting minimal testing to justify this use?

Thank you in advance.

 

[Chrisx]

It seems unlikely to me to be legal in any regulated market.

From what you describe, this is a different mode of contact then the intended use. The biocompatibility endpoints per ISO 10993-1 are different. What may have an acceptable biocompatibility risk for contact for breached or compromised surface (i.e. wound dressing) can be an unacceptable risk for implantation. The biocompatibility risk for contact to mucosal membrane is very different from implantation.