CavatermTM vs TCRE in Women With DUB

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Pnn Medical A/S.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Pnn Medical A/S
ClinicalTrials.gov Identifier:
NCT00549159
First received: October 24, 2007
Last updated: May 19, 2008
Last verified: May 2008
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SF-12, Patients Wishes and Expectations questionnaire, adverse events, need for re-treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  • 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 ClinicalTrials.gov identifier: NCT00549159

Contacts
Contact: Yanhong Yu, Prof. +862061641017 yuyh20050712@hotmail.com
Contact: Nan Liu, MD +8613889903451 annan0103@yahoo.com.cn

Locations
China, Guangdong
Guangzhou Southern Hospital Recruiting
Guangzhou, Guangdong, China, 510515
Principal Investigator: Yanhong Yu, Prof.         
Zhu Jiang Hospital Recruiting
Guangzhou, Guangdong, China, 510282
Principal Investigator: Shi Lei Pan, MD         
Sponsors and Collaborators
Pnn Medical A/S
Investigators
Principal Investigator: Yanhong Yu, Prof. Guangzhou Southern Hospital
  More Information

No publications provided

Responsible Party: Gediminas Puras, Clinical Trial Manager, Pnn Medical A/S
ClinicalTrials.gov Identifier: NCT00549159     History of Changes
Other Study ID Numbers: 2006-0026-06 dd20070920
Study First Received: October 24, 2007
Last Updated: May 19, 2008
Health Authority: China: Food and Drug Administration

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

Additional relevant MeSH terms:
Hemorrhage
Uterine Hemorrhage
Metrorrhagia
Pathologic Processes
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 16, 2014