Librata Endometrial Ablation Device for Heavy Menstrual Bleeding
Research type
Research Study
Full title
LEADER trial- Librata Endometrial Ablation Device Treatment to reduce Menstrual blood loss. A prospective, single-arm study to evaluate the Librata device performance and safety in performing global endometrial ablation in pre-menopausal women with heavy menstrual bleeding.
IRAS ID
213781
Contact name
T. Justin Clark
Contact email
Sponsor organisation
LiNA Medical International Operations
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 1 months, 2 days
Research summary
We aim to recruit 40 women with heavy menstrual bleeding from up to four hospital sites across the UK to assess the safety, feasibility and efficacy of a new thermal balloon (Librata) designed to ablate the womb lining to reduce or stop menstrual bleeding. Women who are seen by a gynaecologist and deemed suitable for an endometrial ablation because of heavy menstrual bleeding eligible for treatment with endometrial ablation will be invited to take part in the study. They will then undergo the endometrial ablation procedure using the Librata device and be followed up over the following 12 months to establish it’s effectiveness in treating heavy menstrual blood loss. The Librata device is a small, handheld, single use, disposable technology making it highly portable in contrast to existing ablative devices. Furthermore, it is smaller than conventional thermal balloon ablation devices and the treatment time more rapid, potentially making treatment more acceptable to patients and feasible for use in both the day case and the outpatient settings.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
17/SW/0005
Date of REC Opinion
13 Feb 2017
REC opinion
Further Information Favourable Opinion