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

October 24, 2007
May 19, 2008
October 2007
October 2009   (final data collection date for primary outcome measure)
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 ]
Reduction of uterine bleeding evaluated by number of patients obtaining amenorrhea, hypomenorrhea or eumenorrhea quantified by PBLAC<75 [ Time Frame: 12 months ]
Complete list of historical versions of study NCT00549159 on ClinicalTrials.gov Archive Site
SF-12, Patients Wishes and Expectations questionnaire, adverse events, need for re-treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
SF-12, Patients Wishes and Expectations questionnaire, adverse events, need for re-treatment [ Time Frame: 12 months ]
Not Provided
Not Provided
 
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 success will be defined as reduction of uterine bleeding evaluated by number of patients obtaining amenorrhea, hypomenorrhea or eumenorrhea quantified by PBLAC<75.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Dysfunctional Uterine Bleeding
  • Device: Thermal Balloon Endometrial Ablation
    Thermal balloon endometrial ablation
  • Device: Transcervical Resection of the Endometrium
    Transcervical resection of the endometrium
  • Experimental: Cavaterm
    Intervention: Device: Thermal Balloon Endometrial Ablation
  • Active Comparator: TCRE
    Transcervical resection of the endometrium
    Intervention: Device: Transcervical Resection of the Endometrium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
158
October 2009
October 2009   (final data collection date for primary outcome measure)

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
Female
30 Years to 60 Years
No
Contact: Yanhong Yu, Prof. +862061641017 yuyh20050712@hotmail.com
Contact: Nan Liu, MD +8613889903451 annan0103@yahoo.com.cn
China
 
NCT00549159
2006-0026-06 dd20070920
No
Gediminas Puras, Clinical Trial Manager, Pnn Medical A/S
Pnn Medical A/S
Not Provided
Principal Investigator: Yanhong Yu, Prof. Guangzhou Southern Hospital
Pnn Medical A/S
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP