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TMBV: Transcervical Myoma Biopsy Video

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Completed
CT.gov ID
NCT04983719
Collaborator
(none)
1
Enrollment
1
Location
6.5
Actual Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To describe the fertility-sparing management of an atypical uterine myoma. Step-by-step video explanation of transcervical biopsy using transabdominal ultrasound guidance, highlighting tips and tricks. Patient consent was obtained for publication of the case.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Fertility-sparing Management of a Suspicion of Leiomyosarcoma: Avoiding Hysterectomy by Performing Transcervical Myoma Biopsy
    Actual Study Start Date :
    Jan 1, 2021
    Actual Primary Completion Date :
    Jul 19, 2021
    Actual Study Completion Date :
    Jul 19, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Evaluation of video [day 1]

      BIOPSY TECHNIQUE DESCRIBED BY VIDEO

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:

    • age >18 years old

    • WOMAN WITH DESIRE FOR PREGNANCY

    • ATYPICAL MYOMA

    Exclusion criteria:
    • age < 18 years old

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Uhmontpellier Montpellier France 34295

    Sponsors and Collaborators

    • University Hospital, Montpellier

    Investigators

    • Study Director: GAUTHIER RATHAT, MD, University Hospital, Montpellier

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Montpellier
    ClinicalTrials.gov Identifier:
    NCT04983719
    Other Study ID Numbers:
    • RECHMPL21_0496
    First Posted:
    Jul 30, 2021
    Last Update Posted:
    Jul 30, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Montpellier
    YOUNG WOMAN WITH DESIRE FOR PREGNANCY
    ATYPICAL MYOMA
    FERTILITY PRESERVATION
    BIOPSY
    Additional relevant MeSH terms:
    Myoma

    Study Results

    No Results Posted as of Jul 30, 2021