Instead of a clinical trial, it would have been interesting to poll as many as possible  Canadians and Americans who have had the procedure and publish the results.  But this wouldn't have the scientific rigor that the medical profession needs to act.  Still it would have given some form to the blizzard of anecdotal evidence which has turned the treatment into a massive grey area.

Depending on the poll results, then you do the clinical trial.

Cheers,
John Meyer