CavatermTM vs TCRE in Women With DUB

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)

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

Study Overview

• Status: Unknown
• Conditions: Dysfunctional Uterine Bleeding
• Intervention / Treatment: Device: Thermal Balloon Endometrial Ablation; Device: Transcervical Resection of the Endometrium

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 Type: Interventional
• Enrollment (Anticipated): 158
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510282
      • Recruiting
      • Zhu Jiang Hospital
      • Principal Investigator: Shi Lei Pan, MD
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • Guangzhou Southern Hospital
      • Principal Investigator: Yanhong Yu, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
SF-12, Patients Wishes and Expectations questionnaire, adverse events, need for re-treatment	12 months

Collaborators and Investigators

• Sponsor: Pnn Medical A/S
• Investigators: Principal Investigator: Yanhong Yu, Prof., Guangzhou Southern Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Anticipated): October 1, 2009
• Study Completion (Anticipated): October 1, 2009

Study Registration Dates

• First Submitted: October 24, 2007
• First Submitted That Met QC Criteria: October 24, 2007
• First Posted (Estimate): October 25, 2007

Study Record Updates

• Last Update Posted (Estimate): May 22, 2008
• Last Update Submitted That Met QC Criteria: May 19, 2008
• Last Verified: May 1, 2008

More Information

Terms related to this study

• Keywords: menorrhagia; endometrial ablation; dysfunctional uterine bleeding
• Additional Relevant MeSH Terms: Pathologic Processes; Uterine Diseases; Hemorrhage; Metrorrhagia; Uterine Hemorrhage
• Other Study ID Numbers: 2006-0026-06 dd20070920