Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03725306
Other study ID # LEADER NA
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date January 1, 2019
Est. completion date December 1, 2022

Study information

Verified date November 2018
Source LiNA Medical
Contact Barbara Cox
Phone 6175964183
Email bco@lina-medical.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study is to evaluate the safety and effectiveness of the endometrial ablation device Librata in reducing menstrual blood loss at 12 months post-treatment when used in pre‑menopausal women with menorrhagia due to benign causes for whom childbearing is complete.


Description:

Menorrhagia is ovulatory (cyclic), heavy bleeding, that should be treated when it interferes with quality of life or causes anemia. It is a common problem and it is estimated that 5% of women aged 30 to 49 seek referral for evaluation and treatment. No structural cause is found in the majority of women with menorrhagia and treatment intends to reduce blood loss and improve quality of life.

First line treatment is medical therapy with hormonal therapy using either the combined contraceptive pill or the levonorgestrel-releasing intrauterine system. These treatments are not suitable for all women and indeed some women may not find them acceptable. For these women, surgical management is then offered with either endometrial ablation or hysterectomy.

The primary objective of this study is to evaluate the clinical success defined as a reduction of menstrual bleeding, defined as a score of 75 or less or 50% reduction from baseline on the Menstrual Pictogram scoring diary at 12 months post-treatment. Additionally, a secondary objective is to determine the primary safety incidence of serious adverse events (SAEs) by 12 months.

The study is designed as a prospective, multi-center, single-arm, controlled trial to demonstrate that the percentage of subjects with reduction in menstrual bleeding at 12 months is significantly greater than 66%. A total of 200 subjects will be enrolled.

The study population will include pre-menopausal women, aged 25-50 with a history of menorrhagia due to benign causes for whom childbearing is complete.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date December 1, 2022
Est. primary completion date September 1, 2022
Accepts healthy volunteers No
Gender Female
Age group 25 Years to 50 Years
Eligibility Candidates for this study must meet ALL of the following criteria:

- Refractory menorrhagia with no organic cause

- Female subject from (and including) age 25 to 50 years

- Uterine sound measurement =6.0 cm to = 10.0cm (external os to fundus).

- A minimum menstrual blood loss

- for subjects not using medical therapy, a Menstrual Pictogram(MP) score of =150 for two baseline cycles within three months prior to treatment OR

- MP score =150 for one month for women who either had

- at least 3 prior months documented failed medical therapy; or

- had 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 visits and data collection requirements

- Subject who is literate or demonstrates an understanding on how to use the Menstrual Pictogram (MP) diary 4.1.1. EXCLUSION CRITERIA

To be enrolled, candidates should NOT meet any exclusion criterion:

- 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.

o Note: Treatment of STD documented in the chart serves as sufficient evidence of infection resolution. Subject may be considered for study enrollment.

- Presence of bacteremia, 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 dysplasia (except CIN I)

- Known/suspected abdominal/pelvic cancer

- Prior uterine surgery (except low segment cesarean 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)

- Currently on anticoagulants

- Abnormal or obstructed cavity as confirmed by transvaginal ultrasound +/- hysteroscopy - specifically:

1. Septate or bicornuate uterus or other congenital malformation of the uterine cavity

2. Submucosal fibroids (grade 0-2) which protrude >1cm into the uterine cavity

3. Polyps >2 cm in maximum diameter

4. Any intramural myoma > 3 cm or which distorts the uterine cavity

- Presence of an intrauterine device (IUD) which the subject unwilling to have removed at the time of the operative visit

- Presence of an implanted contraceptive device (e.g. Essure or Adiana).

- Subject not currently on hormonal birth control therapy and unwilling to use a non-hormonal birth control post-ablation

- Subject wanting concomitant hysteroscopic sterilization

- Subject who is within 6-weeks post-partum

- Any general health condition which, in the opinion of the Investigator, could represent an increased risk for the subject

- Any subject who is currently participating in the primary endpoint phase of an on-going investigational drug or device study or intends future participation in any other research of an investigational drug or device during the primary endpoint phase of this study

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Librata
Hyperthermic endomyometrial treatment via Librata catheter and balloon device

Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
LiNA Medical Infinite Clinical Research, S.A. de C.V., Syntactx, West Virginia University, Pathology Laboratory for Translational Medicine

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Menstrual Bleeding Clinical success defined as a reduction of menstrual bleeding, defined as a score of 75 or less or 50% reduction from baseline on the Menstrual Pictogram scoring diary. 12 months post-treatment
Primary Incidence of serious adverse events (SAEs). The primary safety endpoint 12 months post-treatment
Secondary Changes in Quality of Life Responses from quality of life questionnaires 12 months
Secondary Procedure Time Librata ablation procedure time During procedure
Secondary Menstrual Blood Loss Menstrual blood loss assessment 3, 6, 12, 24 and 36 months
Secondary Rates of Re-Intervention Rate of repeat ablation and/or hysterectomy surgery Month 12
Secondary Incidence of Unanticipated Adverse Device Effects (UADEs) Month 12
See also
  Status Clinical Trial Phase
Completed NCT02824224 - Tamoxifen to Reduce Unscheduled Bleeding in New Users of the Levonorgestrel-releasing Intrauterine System (LNG-IUS) Phase 4
Withdrawn NCT01651468 - The Effect of the Nutraceutical "Hemofix" on the Coagulation System N/A
Recruiting NCT02616731 - Oral Tranexamic Acid Versus Diosmin for Treatment of Menorrhagia in Women Using Copper IUD Phase 1/Phase 2
Terminated NCT02087228 - Evaluation of the Endometrial Cavity After Endometrial Ablation N/A
Withdrawn NCT00953641 - Vaginal Misoprostol for Cervical Ripening Prior to Endometrial Biopsy Phase 3
Completed NCT01436903 - Chances for Success of CavatermTM Surgery as a Function of Uterus Probe Length Phase 4
Withdrawn NCT00768742 - Safety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study N/A
Completed NCT00152256 - A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids Phase 3
Completed NCT00156195 - Study to Evaluate the Safety of Asoprisnil in the Treatment of Uterine Fibroids Phase 3
Completed NCT00160381 - A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids Phase 3
Completed NCT02228174 - Sonography Guided Transcervical Ablation of Uterine Fibroids N/A
Terminated NCT01969396 - Evaluation of the Goldstein SonoBiopsy™ Catheter for Diagnosing Endometrial Pathology N/A
Completed NCT00393198 - Bleeding Pattern and User Satisfaction During Second Consecutive MIRENA® in Contraception and Treatment of Menorrhagia Phase 4
Completed NCT00386308 - Efficacy and Safety Study of XP12B in Women With Menorrhagia Phase 3
Completed NCT00966264 - Hysterectomy and Levonorgestrel Releasing Intrauterine System (LNG-IUS) in the Treatment of Menorrhagia Phase 3
Completed NCT00904709 - The Assessment of Tranexamic Acid in Women With Menorrhagia Who Have Bleeding Disorders Phase 4
Recruiting NCT03670680 - Efficiency of Lina LibrataTM System N/A
Completed NCT02584088 - Ultrasound Appearance of the Endometrium Post Radio-Frequency Ablation
Completed NCT02835391 - PerClot Compared to Usual Care in Gynaecology Procedures N/A
Completed NCT02304510 - Prevalence of Heavy Menstrual Bleeding in Female Population Living in Beijing