Contraceptive UsageTAICSNCT05932537
Ablation of Subcutaneous Contraceptive Implants in the Operating Room
An observational study of Contraceptive Usage, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The ablation of subcutaneous contraceptive implants is usually performed in consultation under local anesthesia. However, it happens that the implant was placed too deeply or that it migrated too deeply making it impossible to remove it in consultation. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Contraceptive Usage
- What is being tested?
- Preoperative visualization techniques
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2022to 31 Dec 2023
- 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: This study covers all patients who underwent explantation of a subcutaneous contraceptive implant in the gynecology operating room of the Hôpital Femme Mère Enfant, between 2018 and 2022.
Who may be able to join
- women over 18
- patient who underwent explantation of a subcutaneous contraceptive implant in the gynecology operating room
- intervention between 2018 and 2022
- person having expressed his non-opposition
Who cannot join
- explantation outside the operating room
- inability to understand the information given
- person deprived of liberty
- person under guardianship
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Gynaecology Department, Hôpital Femme Mère Enfant, Hospices Civils de Lyon
Bron, 69677
Gautier CHENE, MD, 04 72 35 58 70 ext. +33, gautier.chene@chu-lyon.fr
Gautier CHENE, MD
About this study
Official title: Technical Description of the Ablation of Subcutaneous Contraceptive Implants in the Operating Room
The ablation of subcutaneous contraceptive implants is usually performed in consultation under local anesthesia. However, it happens that the implant was placed too deeply or that it migrated too deeply making it impossible to remove it in consultation. These patients should then be referred to reference centers so that the explantation takes place in the operating room. The investigators propose to describe their techniques for preoperative visualization of the implant and their techniques for surgical explantation for educational purposes.
- Conditions
- Contraceptive Usage
- Being tested
- Preoperative visualization techniques
- Keywords
- subcutaneous contraceptive implants, ablation, operating room
- Medical subject headings
- Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative visualization techniquesProcedure or surgery
describe techniques for pre-operative visualization of subcutaneous contraceptive implants
| Study group | Role | What they receive |
|---|---|---|
| subcutaneous contraceptive implants | patients who have benefited from explantation of a subcutaneous contraceptive implant in the gynecology operating room Receives: Procedure: Preoperative visualization techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound for visualization of implants
Percentage of patients with an ultrasound to visualize the implants
Measured: preoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start15 Sep 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contraceptive UsageStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05932537
- Sponsor's protocol ID
- 69HCL22_1032
- Acronym
- TAICS
- Status last verified
- Jul 2023
- First submitted
- 14 Dec 2022
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technical Description of the Ablation of Subcutaneous Contraceptive Implants in the Operating Room
- ClinicalTrials.gov ID
- NCT05932537
- Acronym / sponsor ID
- TAICS / 69HCL22_1032
- Conditions
- Contraceptive Usage
- Keywords
- subcutaneous contraceptive implants, ablation, operating room
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 6 Jul 2023 (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.
The ablation of subcutaneous contraceptive implants is usually performed in consultation under local anesthesia. However, it happens that the implant was placed too deeply or that it migrated too deeply making it impossible to remove it in consultation. These patients should then be referred to reference centers so that the explantation takes place in the operating room. The investigators propose to describe their techniques for preoperative visualization of the implant and their techniques for surgical explantation for educational purposes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| subcutaneous contraceptive implants | – | Procedure: Preoperative visualization techniquespatients who have benefited from explantation of a subcutaneous contraceptive implant in the gynecology operating room |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study covers all patients who underwent explantation of a subcutaneous contraceptive implant in the gynecology operating room of the Hôpital Femme Mère Enfant, between 2018 and 2022.
Key inclusion criteria (4 listed)
- women over 18
- patient who underwent explantation of a subcutaneous contraceptive implant in the gynecology operating room
- intervention between 2018 and 2022
- person having expressed his non-opposition
Key exclusion criteria (4 listed)
- explantation outside the operating room
- inability to understand the information given
- person deprived of liberty
- person under guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative visualization techniquesdescribe techniques for pre-operative visualization of subcutaneous contraceptive implants | Procedure or surgery | subcutaneous contraceptive implants |
Primary outcome
Ultrasound for visualization of implants
Time frame: preoperatively
Percentage of patients with an ultrasound to visualize the implants
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
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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.
Gynaecology Department, Hôpital Femme Mère Enfant, Hospices Civils de Lyon
Bron, France
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 Contraceptive Usage, run by Hospices Civils de Lyon 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 13 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound for visualization of implants (time frame: preoperatively). 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 13 Nov 2023.