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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01910584
Other study ID # First-GYN-SYSU-2012
Secondary ID
Status Recruiting
Phase N/A
First received July 20, 2013
Last updated July 25, 2013
Start date November 2012
Est. completion date November 2015

Study information

Verified date September 2012
Source First Affiliated Hospital, Sun Yat-Sen University
Contact Shu-Qin Chen, PhD & MD
Phone +862087332200
Email chenshuqin1021@163.com
Is FDA regulated No
Health authority China: Ethics Committee
Study type Observational

Clinical Trial Summary

The aim of this study is to investigate the influence on the quality of life and sexual function before, 6 month and one year after Novasure Endometrial Ablation in the treatment of Menorrhagia.


Description:

patients diagnosed menorrhagia scheduled for Novasure Endometrial Ablation because of menorrhagia between november, 2012 and november, 2014 are enrolled to this study.

patients are asked to complete preoperative questionnaires considering Health Related Quality of Life questionnaire(HRQoL) and sexual Female Sexual Functioning Index questionnaire(FSFI). Same questionnaires will also be completed six months and one year after operation.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date November 2015
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Female
Age group 25 Years to 50 Years
Eligibility Inclusion Criteria:

- clinical diagnosis of menorrhagia

- family complete

- normal endometrial pathology

- had not been referred specifically for surgery

- with normal uterine cavity

Exclusion Criteria:

- pregnancy or demand to preserve fertility

- acute reproductive tract inflammation or urinary tract inflammation

- pathology demonstrate endometrial cancer or precancerous change

- acute pelvic inflammation

- intrauterine device(IUD) in uterus

- depth of uterine cavity less than 4cm or more than 10cm

- pathologic myometrium( such as history of Hysteromyomectomy or classical cesarean section)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Procedure:
Novasure endometrial ablation
Novasure endometrial ablation is the second generation endometrial ablation treatment aimed to cure the dysfunctional uterine bleeding(DUB),including menorrhagia.

Locations

Country Name City State
China The First Affiliated Hospital of Sun yat-sen University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Shu-Qin Chen

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of life and Sexual Function before, six month and one year after the Novasure Endometrial Ablation Quality of life assessed with Health Related Quality of Life questionnaire(HRQoL) before, six month and one year after the Novasure Endometrial Ablation; Sexual Function measured with Female Sexual Functioning Index questionnaire(FSFI) before, six month and one year after the Novasure Endometrial Ablation one year after Novasure Endometrial Ablation No
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