Class II
Clinical evidence strategy plan for a Class II closed-loop wearable in phantom limb syndrome
A Clinical Evidence Strategy Plan, including an FDA-ready Clinical Investigational Plan synopsis for Pre-Sub.
- Client
- Class II non-invasive, closed-loop wearable neuromodulation for phantom limb syndrome, with or without pain
- Work
- Clinical evidence strategy
- closed-loop
- Class II
Situation
An early-stage Class II wearable that delivers closed-loop, transcutaneous neuromodulation at the residual limb for phantom limb syndrome, with or without pain, needed a clinical evidence strategy before pivotal work and FDA Pre-Sub. The company required a written plan for the claims, the evidence gaps, and the pivotal trial.
Approach
We developed a Clinical Evidence Strategy Plan (CESP): a document that maps intended use and claims against existing evidence, names the gaps, and sequences the studies the program will need. The CESP included a pivotal trial synopsis written as an FDA-ready Clinical Investigational Plan (CIP) synopsis for Pre-Sub.
Outcome
A completed CESP, including an FDA-ready CIP synopsis the sponsor could take into Pre-Sub.