CavatermTM vs TCRE in Women With DUB

Sponsor

Pnn Medical A/S (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00549159

Collaborator

(none)

158

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of study is to compare the treatment success in the study groups.

Condition or Disease	Intervention/Treatment	Phase
Dysfunctional Uterine Bleeding	Device: Thermal Balloon Endometrial Ablation Device: Transcervical Resection of the Endometrium	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

158 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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 Start Date :

Oct 1, 2007

Anticipated Primary Completion Date :

Oct 1, 2009

Anticipated Study Completion Date :

Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cavaterm	Device: Thermal Balloon Endometrial Ablation Thermal balloon endometrial ablation
Active Comparator: TCRE Transcervical resection of the endometrium	Device: Transcervical Resection of the Endometrium Transcervical resection of the endometrium

Arm

Intervention/Treatment

Experimental: Cavaterm

Device: Thermal Balloon Endometrial Ablation

Thermal balloon endometrial ablation

Active Comparator: TCRE

Transcervical resection of the endometrium

Device: Transcervical Resection of the Endometrium

Transcervical resection of the endometrium

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

SF-12, Patients Wishes and Expectations questionnaire, adverse events, need for re-treatment [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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