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

NCT02971189 | Unknown DMC

• 1 other identifier: Birmingham WHC
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Heavy Menstrual Bleeding

Outcome Measures

Primary Outcomes (1)

• Procedure success defined as device success (completion of treatment cycles according to device specifications) and no occurence of intra-procedural complications.

  Day of surgery

Secondary Outcomes (4)

• rates of bleeding as measured by menstrual pictogram

  12 months

• rate of serious adverse device effects

  day 30 post-operatively

• Rates of re-intervention for menstrual related bleeding or pain and/or hysterectomy

  12 months

• Rates of patient satisfaction

  12 months

Study Arms (1)

Librata endometrial ablation

OTHER

Librata thermal balloon endometrial ablation 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.

Device: Librata Endometrial Ablation

Interventions

Librata Endometrial Ablation DEVICE

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.

Librata endometrial ablation

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Refractory heavy menstrual bleeding with no definable organic cause
• Female subject from (and including) age 25 to 50 years
• Uterine sound measurement between 6.0 to 10.0cm (external os to fundus).
• A minimum menstrual blood loss of
• Menstrual Pictogram (MP) score of ≥150 for 3 consecutive months prior to study enrollment; OR,
• MP score ≥150 for one month for women who either had:
• at least 3 prior months documented failed medical therapy; or
• a contraindication to medical therapy; or
• refused medical therapy
• Premenopausal at enrollment as determined by FSH measurement ≤ 40 IU/L
• Not pregnant and no desire to conceive at any time
• Subject agrees to use a reliable form of contraception. If a hormonal birth control method is used, the subject must have been on said method for ≥ 3 months prior to enrollment and agrees to remain on the same hormonal regimen through their study participation.
• Able to provide written informed consent using a form that has been approved by the reviewing IRB/EC
• Subject agrees to follow-up schedule and data collection requirements
• Subject is literate or demonstrates an understanding on how to collect menstrual blood loss products, and use of the Menstrual Pictogram (MP) diary

You may not qualify if:

• Pregnancy or subject with a desire to become pregnant
• Endometrial hyperplasia as confirmed by histology
• Presence of active endometritis
• Active pelvic inflammatory disease
• Active sexually transmitted disease (STD), at the time of ablation.
• Note: Treatment of STD documented in the chart serves as sufficient evidence of infection resolution. Subject may be considered for study enrollment.
• Presence of bacteraemia, sepsis, or other active systemic infection
• Active infection of the genitals, vagina, cervix, uterus or urinary tract at the time of the procedure
• Known/suspected gynecological malignancy within the past 5 years
• Known clotting defects or bleeding disorders
• Untreated/unevaluated cervical dyskaryosis (except CIN I)
• Known or suspected abdominal/pelvic cancer
• Prior uterine surgery (except lower segment caesarean section) that interrupts the integrity of the uterine wall (e.g., myomectomy or classical cesarean section)
• Previous endometrial ablation procedure
• Currently on medications that could thin the myometrial muscle, such as long-term steroid use (except inhaler or nasal therapy for asthma)

Sponsors & Collaborators

• Birmingham Women's NHS Foundation Trust: lead

Related Publications (1)

• Shaw RW, Brickley MR, Evans L, Edwards MJ. Perceptions of women on the impact of menorrhagia on their health using multi-attribute utility assessment. Br J Obstet Gynaecol. 1998 Nov;105(11):1155-9. doi: 10.1111/j.1471-0528.1998.tb09968.x.

  PMID: 9853763 BACKGROUND

Related Links

• link to pubmed

MeSH Terms

Conditions

Menorrhagia

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Study Officials

• Justin Clark, MB ChB, MD

  Birmingham Women's NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Justin Clark, MB ChB, MD

CONTACT

0044 1216074712; t.j.clark@doctors.org.uk

Helen Stevenson, MB ChB

CONTACT

0044 121472177; helen_stevenson@bwnft.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Gynaecologist

Study Record Dates

• First Submitted: November 19, 2016
• First Posted: November 22, 2016
• Study Start: December 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: August 1, 2017
• Last Updated: November 22, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share