NCT02971189

Librata Endometrial Ablation Device Treatment to Reduce Menstrual Blood Loss in Sites Across the United Kingdom

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Birmingham Women's NHS Foundation Trust · Other Government
• Sex: Female
• Age: 25 Years – 50 Years
• Healthy volunteers: Accepted

Summary

A prospective, single-arm, non-randomised study to evaluate the Librata device performance and acute safety in performing global endometrial ablation in pre-menopausal women with heavy menstrual bleeding.

Detailed description

4 clinical sits around the UK aim to recruit 40 women into a study to assess the primary objective of procedure success using the Librata endometrial ablation device, as defined as device success (completion of treatment cycles according to device specifications) and no occurrence of intra-procedural complications. The investigators will also assess the secondary objectives of: 1. Rates of bleeding at months 3, 6 and 12 as measured by menstrual pictogram 2. Rate of serious adverse device effects through to day 30 post-operatively 3. Rates of re-intervention for menstrual related bleeding or pain and/or hysterectomy at 6 and 12 months 4. Rates of patient satisfaction at 6 and 12 months.

Conditions

• Heavy Menstrual Bleeding

Interventions

Type	Name	Description
DEVICE	Librata Endometrial Ablation	The treatment procedure will be performed in accordance with the physician's routine endometrial ablation practice and in accordance with the requirements of the LibrataTM IFU. The uterine cavity will be systematically inspected using hysteroscopy prior the ablative procedure (after any blind cervical dilatation) and post the ablative procedure to estimate the completeness of endometrial destruction and to exclude uterine trauma including uterine perforation. The patient will undergo standard post-operative monitoring and recovery according to usual hospital practices. An assessment will be made for any ablation procedure or device related serious adverse events.

Timeline

• Start date: 2016-12-01
• Primary completion: 2017-01-01
• Completion: 2017-08-01
• First posted: 2016-11-22
• Last updated: 2016-11-22