Status:
UNKNOWN
Vaginoscopy Compared to Traditional Hysteroscopy for Hysteroscopy Morcellation in Outpatient Clinic. A Randomized Trial
Lead Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborating Sponsors:
Hologic, Inc.
Conditions:
Leiomyoma of Uterus
Eligibility:
FEMALE
18-52 years
Phase:
NA
Brief Summary
This study is a randomized controlled trial take place in a fertility outpatient clinic in an academic hospital. Women between 18 and 52 years old requiring polypectomy or myomectomy by hysteroscopy m...
Detailed Description
78 participants will be randomised in two groups: 1. traditional hysteroscopy: under intravenous sedation, hysteroscopic morcellation is perform after speculum insertion, vaginal cleansing, and parac...
Eligibility Criteria
Inclusion
- polyp or fibroid previously diagnosed by hysteroscopy
- polyp less than 2 cm
- submucosal fibroid (type 0 or 1 according to the 2011 FIGO uterine fibroid classification) less than 2 cm
- if more than 1 fibroid: total fibroid have to be less or equal 4 cm
Exclusion
- cervical stenosis
- polyp or fibroid more than 2 cm
- pregnancy
- blood dyscrasia
Key Trial Info
Start Date :
September 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT04373694
Start Date
September 9 2020
End Date
December 31 2024
Last Update
January 12 2023
Active Locations (1)
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1
CHUM - Clinique Médecine et biologie de la reproduction
Montreal, Quebec, Canada, H2X 1P1