Clinical trial NCT00549159: CavatermTM vs TCRE in Women With DUB
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Dysfunctional Uterine Bleeding
Keywords: menorrhagia
dysfunctional uterine bleeding
endometrial ablation
Lead sponsor: Pnn Medical A/S
Sponsor class: INDUSTRY
First posted: 2007-10-25
Enrollment: 158
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Reduction of uterine bleeding evaluated by number of patients obtaining amenorrhea, hypomenorrhea or eumenorrhea quantified by PBLAC<75
timeFrame: 12 months
Secondary outcomes:
measure: SF-12, Patients Wishes and Expectations questionnaire, adverse events, need for re-treatment
timeFrame: 12 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhu Jiang Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou Southern Hospital
state: Guangdong
Study officials:
affiliation: Guangzhou Southern Hospital
name: Yanhong Yu, Prof.
role: PRINCIPAL_INVESTIGATOR
References: