Replies to post #326658 on Bioelectronics Corp (BIEL)

[GetSeriousOK]

Sure, 20 to 80 volunteers in a Phase 1 Study, which is designed to prove safety, not efficacy.

But that's moot because Ilfeld's study is a PILOT Study, not a study designed to clinically prove anything. It doesn't have ENDPOINTS, it has AIMS, and they are:

Specific Aim 1: To determine the feasibility and optimize the protocol for subsequent clinical trials that will compare the addition of nonthermal, pulsed shortwave therapy to usual and customary analgesia following moderate-to-severely painful surgical procedures.

Specific Aim 2: To estimate the treatment effect of adding nonthermal, pulsed shortwave therapy to usual and customary analgesia on pain and opioid consumption following moderate-to-severely painful surgical procedures. This will provide an idea of the optimal surgical procedures amenable to this analgesic technique and allow determination of the required sample sizes of subsequent definitive clinical trials.

https://clinicaltrials.gov/study/NCT05399355