AtypicalTMBVNCT04983719
Transcervical Myoma Biopsy Video
An observational study of Atypical and Myoma, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2021to 19 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: YOUNG WOMAN WITH DESIRE FOR PREGNANCY AND ATYPICAL MYOMA
Who may be able to join
- age >18 years old
- WOMAN WITH DESIRE FOR PREGNANCY
- ATYPICAL MYOMA
Who cannot join
- age < 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fertility-sparing Management of a Suspicion of Leiomyosarcoma: Avoiding Hysterectomy by Performing Transcervical Myoma Biopsy
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.
- Keywords
- YOUNG WOMAN WITH DESIRE FOR PREGNANCY, ATYPICAL MYOMA, FERTILITY PRESERVATION, BIOPSY
- Medical subject headings
- Myoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of video
BIOPSY TECHNIQUE DESCRIBED BY VIDEO
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start1 Jan 2021
- Primary completion19 Jul 2021
- Study completion19 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtypicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- GAUTHIER RATHAT, MD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04983719
- Sponsor's protocol ID
- RECHMPL21_0496
- Acronym
- TMBV
- Status last verified
- Jul 2021
- First submitted
- 20 Jul 2021
- Last updated
- 30 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fertility-sparing Management of a Suspicion of Leiomyosarcoma: Avoiding Hysterectomy by Performing Transcervical Myoma Biopsy
- ClinicalTrials.gov ID
- NCT04983719
- Acronym / sponsor ID
- TMBV / RECHMPL21_0496
- Keywords
- YOUNG WOMAN WITH DESIRE FOR PREGNANCY, ATYPICAL MYOMA, FERTILITY PRESERVATION, BIOPSY
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 19 Jul 2021 (actual)
- Study completion
- 19 Jul 2021 (actual)
- First posted
- 30 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- YOUNG WOMAN WITH DESIRE FOR PREGNANCY AND ATYPICAL MYOMA
Key inclusion criteria (3 listed)
- age >18 years old
- WOMAN WITH DESIRE FOR PREGNANCY
- ATYPICAL MYOMA
Key exclusion criteria (1 listed)
- age < 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of video
Time frame: day 1
BIOPSY TECHNIQUE DESCRIBED BY VIDEO
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2021.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GAUTHIER RATHAT, MD study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atypical and Myoma, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of video (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2021.