Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
158 participants
INTERVENTIONAL
2007-10-31
2009-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Cavaterm
Thermal Balloon Endometrial Ablation
Thermal balloon endometrial ablation
TCRE
Transcervical resection of the endometrium
Transcervical Resection of the Endometrium
Transcervical resection of the endometrium
Interventions
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Thermal Balloon Endometrial Ablation
Thermal balloon endometrial ablation
Transcervical Resection of the Endometrium
Transcervical resection of the endometrium
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
30 Years
60 Years
FEMALE
No
Sponsors
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Pnn Medical A/S
INDUSTRY
Responsible Party
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Pnn Medical A/S
Principal Investigators
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Yanhong Yu, Prof.
Role: PRINCIPAL_INVESTIGATOR
Guangzhou Southern Hospital
Locations
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Zhu Jiang Hospital
Guangzhou, Guangdong, China
Guangzhou Southern Hospital
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Other Identifiers
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2006-0026-06 dd20070920
Identifier Type: -
Identifier Source: org_study_id