CavatermTM vs TCRE in Women With DUB

Study Overview
=================
Brief Summary
-----------------
The purpose of study is to compare the treatment success in the study groups.

Detailed Description
-----------------
Study success will be defined as reduction of uterine bleeding evaluated by number of patients obtaining amenorrhea, hypomenorrhea or eumenorrhea quantified by PBLAC<75.

Official Title
-----------------
Multicenter Randomized Clinical Trial to Evaluate the Safety and Effectiveness of Cavaterm TM Thermal Balloon Endometrial Ablation in Women With Dysfunctional Uterine Bleeding Compared to Transcervical Resection of the Endometrium (TCRE)

Conditions
-----------------
Dysfunctional Uterine Bleeding

Intervention / Treatment
-----------------
* Device: Thermal Balloon Endometrial Ablation
* Device: Transcervical Resection of the Endometrium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willingness and adequate mental capacity to sign written, informed consent Willingness to adhere to study plan regarding control visits and recording of PBLAC > 30 years old Pre-menopausal as determined by FSH ≤30 Agree not to use hormonal contraception or any other intervention for bleeding during study Suitable for local and/or general anesthesia A minimum PBLAC score of ≥ 150 for three months prior to study enrollment; OR PBLAC score 150 for one month for women who 1) had at least 3 (documented) prior months of failed medical therapy; 2) had a contraindication to medical therapy; or 3) refused medical therapy Uterine cavity sound measurement ≥ 4 cm and ≤ 10 cm. Exclusion Criteria: Presence of bacteriaemia, sepsis, or other active systemic infection Active pelvic inflammatory disease Clotting defects or bleeding disorders Unwillingness to use a non-hormonal birth control post-ablation Desire for future fertility Abnormal cavity as confirmed by hysteroscopy, transvaginal ultrasound or HSG e.g. large fibroids, septum etc. Small submucosal fibroids defined as < 2 cm are in this context not considered abnormal. Any condition leading to possible uterine wall weakness with total wall thickness < 15 mm e.g. at c.section, postmyomectomy scars etc. In case of uniform uterine wall the wall thickness at the fundus should be measured. Premalignant or malignant uterine condition within the last five years as confirmed by histology Pregnancy Cervical length > 6 cm. Uterine cavity >30 ml defined as balloon can be filled with 30ml glucose solution without reaching the target pressure of 240 mmHg. (These patients may still be treated as planned but will be withdrawn from the study and their data will be analysed separately. The patients will be recorded as screening failures). Previous ablation or subtotal hysterectomy

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cavaterm<br> | Device: Thermal Balloon Endometrial Ablation<br>* Thermal balloon endometrial ablation<br>|
| Active Comparator: TCRE<br>Transcervical resection of the endometrium | Device: Transcervical Resection of the Endometrium<br>* Transcervical resection of the endometrium<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of uterine bleeding evaluated by number of patients obtaining amenorrhea, hypomenorrhea or eumenorrhea quantified by PBLAC<75 |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-12, Patients Wishes and Expectations questionnaire, adverse events, need for re-treatment |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
menorrhagia, dysfunctional uterine bleeding, endometrial ablation