CavatermTM vs TCRE in Women With DUB (NCT00549159) | Clinical Trial Compass
UnknownPhase 4
CavatermTM vs TCRE in Women With DUB
China158 participantsStarted 2007-10
Plain-language summary
The purpose of study is to compare the treatment success in the study groups.
Who can participate
Age range30 Years – 60 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 histolog…
What they're measuring
1
Reduction of uterine bleeding evaluated by number of patients obtaining amenorrhea, hypomenorrhea or eumenorrhea quantified by PBLAC<75