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Sponsored by: |
Pnn Medical A/S |
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Information provided by: | Pnn Medical A/S |
ClinicalTrials.gov Identifier: | NCT00549159 |
The purpose of study is to compare the treatment success in the study groups.
Condition | Intervention | Phase |
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Dysfunctional Uterine Bleeding |
Device: Thermal Balloon Endometrial Ablation Device: Transcervical Resection of the Endometrium |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study |
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) |
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 |
---|---|
Cavaterm: Experimental |
Device: Thermal Balloon Endometrial Ablation
Thermal balloon endometrial ablation
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TCRE: Active Comparator
Transcervical resection of the endometrium
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Device: Transcervical Resection of the Endometrium
Transcervical resection of the endometrium
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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 |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Yanhong Yu, Prof. | +862061641017 | yuyh20050712@hotmail.com |
Contact: Nan Liu, MD | +8613889903451 | annan0103@yahoo.com.cn |
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 |
Principal Investigator: | Yanhong Yu, Prof. | Guangzhou Southern Hospital |
Responsible Party: | Pnn Medical A/S ( Gediminas Puras, Clinical Trial Manager ) |
Study ID Numbers: | 2006-0026-06 dd20070920 |
Study First Received: | October 24, 2007 |
Last Updated: | May 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00549159 |
Health Authority: | China: State Food and Drug Administration |
menorrhagia dysfunctional uterine bleeding endometrial ablation |
Genital Diseases, Female Metrorrhagia Uterine Hemorrhage |
Uterine Diseases Menorrhagia Hemorrhage |
Pathologic Processes |