Menorrhagia treatment Phase III trial completed:
This article was originally published in Clinica
BEI Medical Systems has finished treating all patients involved in a US Phase III trial of its Hydro ThermAblator system for the treatment of excessive uterine bleeding, or menorrhagia. The 276-patient trial compared the safety and efficacy of the system with roller ball ablation, one of the current treatments for the condition. The Teterboro, New Jersey-based company, which plans to follow the patients for a year before filing a pre-market approval application with the FDA, will submit a six-month, interim patient follow-up analysis to the agency during the first quarter of 2000.