CavatermTM vs TCRE in Women With DUB

Dysfunctional Uterine Bleeding Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00549159
• Other study ID #: 2006-0026-06 dd20070920
• Status: Recruiting
• Phase: Phase 4
• First received: October 24, 2007
• Last updated: May 19, 2008
• Start date: October 2007
• Est. completion date: October 2009

Study information

• Verified date: May 2008
• Source: Pnn Medical A/S
• Contact: Yanhong Yu, Prof.
• Phone: +862061641017
• Email: yuyh20050712[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 158
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dysfunctional Uterine Bleeding
• Hemorrhage
• Metrorrhagia
• Uterine Hemorrhage

Intervention

Device:
• Thermal Balloon Endometrial Ablation
Thermal balloon endometrial ablation
• Transcervical Resection of the Endometrium
Transcervical resection of the endometrium

Locations

Country	Name	City	State
China	Guangzhou Southern Hospital	Guangzhou	Guangdong
China	Zhu Jiang Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Pnn Medical A/S

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of uterine bleeding evaluated by number of patients obtaining amenorrhea, hypomenorrhea or eumenorrhea quantified by PBLAC<75		12 months	No
Secondary	SF-12, Patients Wishes and Expectations questionnaire, adverse events, need for re-treatment		12 months	No