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CavatermTM vs TCRE in Women With DUB

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2008 by Pnn Medical A/S.
Recruitment status was:  Recruiting
Information provided by:
Pnn Medical A/S Identifier:
First received: October 24, 2007
Last updated: May 19, 2008
Last verified: May 2008
The purpose of study is to compare the treatment success in the study groups.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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)

Resource links provided by NLM:

Further study details as provided by Pnn Medical A/S:

Primary Outcome Measures:
  • Reduction of uterine bleeding evaluated by number of patients obtaining amenorrhea, hypomenorrhea or eumenorrhea quantified by PBLAC<75 [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • SF-12, Patients Wishes and Expectations questionnaire, adverse events, need for re-treatment [ Time Frame: 12 months ]

Estimated Enrollment: 158
Study Start Date: October 2007
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00549159

China, Guangdong
Zhu Jiang Hospital
Guangzhou, Guangdong, China, 510282
Guangzhou Southern Hospital
Guangzhou, Guangdong, China, 510515
Sponsors and Collaborators
Pnn Medical A/S
Principal Investigator: Yanhong Yu, Prof. Guangzhou Southern Hospital
  More Information

Responsible Party: Gediminas Puras, Clinical Trial Manager, Pnn Medical A/S Identifier: NCT00549159     History of Changes
Other Study ID Numbers: 2006-0026-06 dd20070920 
Study First Received: October 24, 2007
Last Updated: May 19, 2008

Keywords provided by Pnn Medical A/S:
dysfunctional uterine bleeding
endometrial ablation

Additional relevant MeSH terms:
Uterine Hemorrhage
Pathologic Processes
Uterine Diseases
Genital Diseases, Female processed this record on February 20, 2017