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)

Pnn Medical A/S2 sites in 1 country158 target enrollmentOctober 2007

ConditionsDysfunctional Uterine Bleeding

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Dysfunctional Uterine Bleeding
Sponsor: Pnn Medical A/S
Enrollment: 158
Locations: 2
Primary Endpoint: Reduction of uterine bleeding evaluated by number of patients obtaining amenorrhea, hypomenorrhea or eumenorrhea quantified by PBLAC<75
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

October 2007

End Date

October 2009

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Pnn Medical A/S

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.