CavatermTM vs TCRE in Women With DUB

Phase 4

• Conditions: Dysfunctional Uterine Bleeding
• Interventions: Device: Thermal Balloon Endometrial Ablation; Device: Transcervical Resection of the Endometrium

• Registration Number: NCT00549159
• Lead Sponsor: Pnn Medical A/S

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.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-10-24
• Study First Submitted QC: 2007-10-24
• Study First Posted: 2007-10-25
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-19
• Last Update Posted: 2008-05-22
• Primary Completion: 2009-10
• Study Completion: 2009-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 158

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cavaterm	Thermal Balloon Endometrial Ablation	-
TCRE	Transcervical Resection of the Endometrium	Transcervical resection of the endometrium

Primary Outcome Measures

Name	Time	Method
Reduction of uterine bleeding evaluated by number of patients obtaining amenorrhea, hypomenorrhea or eumenorrhea quantified by PBLAC<75	12 months

Secondary Outcome Measures

Name	Time	Method
SF-12, Patients Wishes and Expectations questionnaire, adverse events, need for re-treatment	12 months

Trial Locations

Locations (2)

Guangzhou Southern Hospital; 🇨🇳 Guangzhou, Guangdong, China

Zhu Jiang Hospital; 🇨🇳 Guangzhou, Guangdong, China