Status:
UNKNOWN
Hysteroscopic Guided Endometrial Sampling: Prospective Comparison Between 5Fr and 7Fr Biopsy Forceps (HYSTEROBIO)
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Biopsy
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Indication for hysteroscopic guided biopsy compared to blind biopsy have been little evaluated. However, this kind of biopsy is usually performed in many centre. They allow exploration of uterine cavi...
Detailed Description
Blind biopsies using Novak or Cormier cannula had limits. Demirkiran et al conclude on 673 women that histology was similar between biopsies and hysterectomy in only 67% of cases. Others studies concl...
Eligibility Criteria
Inclusion
- • Woman over 18 year-old with abnormal uterine bleeding (or endometrium thickness over 10mm) and risk factors of endometrial carcinoma, or endometrium thickness over 5mm in a menopausal woman or abnormal uterine bleeding after 45 years old.
- Woman who speak and understand french
- Woman who give her written informed consent
- Woman covered by french medical insurance
Exclusion
- • Pregnant or breastfeeding patient
- Patient under guardianship, curators or safeguard of justice.
- Patient participating in another ongoing study.
Key Trial Info
Start Date :
September 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 20 2021
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT04519554
Start Date
September 20 2020
End Date
December 20 2021
Last Update
September 1 2020
Active Locations (1)
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1
AP-HP, Bicêtre Hospital
Le Kremlin-Bicêtre, France, 94275