Ablation of Subcutaneous Contraceptive Implants in the Operating Room (TAICS)

July 12, 2023 updated by: Hospices Civils de Lyon

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France, 69677
        • Recruiting
        • Gynaecology Department, Hôpital Femme Mère Enfant, Hospices Civils de Lyon
        • Principal Investigator:
          • Gautier CHENE, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • explantation outside the operating room
  • inability to understand the information given
  • person deprived of liberty
  • person under guardianship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
subcutaneous contraceptive implants
patients who have benefited from explantation of a subcutaneous contraceptive implant in the gynecology operating room
Procedure: Preoperative visualization techniques
describe techniques for pre-operative visualization of subcutaneous contraceptive implants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ultrasound for visualization of implants
Time Frame: preoperatively
Percentage of patients with an ultrasound to visualize the implants
preoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2022

Primary Completion (Actual)

October 31, 2022

Study Completion (Estimated)

August 30, 2023

Study Registration Dates

First Submitted

December 14, 2022

First Submitted That Met QC Criteria

June 27, 2023

First Posted (Actual)

July 6, 2023

Study Record Updates

Last Update Posted (Actual)

July 13, 2023

Last Update Submitted That Met QC Criteria

July 12, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 69HCL22_1032

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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