Intra-uterine adhesions
Conditions
Interventions
Womed Leaf is inserted immediately after completion of the endometrial ablation
Name: Womed Leaf*
Device group: Intrauterine adhesion barrier
Device status: CE mark
Description:
Womed Leaf* is a ste
Sponsors
Catharina-ziekenhuis
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1.Patient with refractory heavy menstrual bleeding scheduled for endometrial ablation with NovaSure system 2.Women 30 years old or older; 3.Subjects who are willing to provide a written informed consent as approved by the applicable Ethics Committee / IRB prior to participating in this clinical investigation. 4.Subjects who can comply with the study follow-up and other study requirements.
Exclusion criteria
Exclusion criteria: 1. Cavity length 8 2. Perforation during the ablation procedure 3. Previous adhesiolysis procedure or diagnosis of Asherman's disease. 4. An abnormal uterine cavity at the time of ablation according to ESHRE classification I to V, such as unicornis, bicornis, septate, duplex 5. Medical history of cervical or endometrial cancer 6. Active pelvic infection or medical history of pelvic peritonitis 7. An intrauterine device in situ 8. Known contraindication or hypersensitivity to PEO or PLA 9. Current participation in another clinical investigation that has not yet received the primary endpoint 10. Any other condition that makes participation in the study contrary to the patient*s best interests.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy endpoint: AFS score focused on the intrauterine adhesion formation following Novasure (i.e. considering only extent of cavity involved and type of adhesions after) at 4-6 weeks Primary safety endpoints: 1. Assessment of cavity findings at 4-6 weeks a. Ability to perform a biopsy anywhere within the uterine cavity b. Ability to adequately visualise the endometrium to evaluate for pathologic change c. Qualitative description of the endometrial cavity (i.e. presence of viable endometrium vs cicatricial/fibrotic tissue*) 2. Number of Serious Adverse Events and Serious Device-related Adverse Events at 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Each component of AFS score at second look hysteroscopy: extent of IUA, type of IUA 2. Binary rate of intrauterine adhesions on hysteroscopy 3. Change in menstrual bleeding at 3 months using Pictorial Blood Loss Assessment Chart 4. Level of dysmenorrhea before and after 3 months (painful cramping associated with menstruation) 5. Level of patient satisfaction on ablation procedure on a scale from 0 to 5 from the worst to the best health care possible. 6. Patients complaints (discharge, dyspareunia) 7. Is it possible to perform a second ablation procedure in case needed? 8. Histopathology assessment of hysterectomy piece (in the case a hysterectomy is performed few years after endometrial ablation) 9. Histopathology assessment of endometrial biopsy taken at second look hysteroscopy | — |
Countries
Netherlands
Outcome results
None listed