TAICS: Ablation of Subcutaneous Contraceptive Implants in the Operating Room

• Sponsor: Hospices Civils de Lyon (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05932537
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 11.5
• Patients Per Site Per Month: 4.4

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Contraceptive Usage	Procedure: Preoperative visualization techniques

Study Design

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Technical Description of the Ablation of Subcutaneous Contraceptive Implants in the Operating Room
• Actual Study Start Date: Sep 15, 2022
• Actual Primary Completion Date: Oct 31, 2022
• Anticipated Study Completion Date: Aug 30, 2023

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Ultrasound for visualization of implants [preoperatively]

   Percentage of patients with an ultrasound to visualize the implants

Eligibility Criteria

Criteria

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gynaecology Department, Hôpital Femme Mère Enfant, Hospices Civils de Lyon	Bron		France	69677

Sponsors and Collaborators

• Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospices Civils de Lyon
• ClinicalTrials.gov Identifier: NCT05932537
• Other Study ID Numbers: 69HCL22_1032
• First Posted: Jul 6, 2023
• Last Update Posted: Jul 13, 2023
• Last Verified: Jul 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hospices Civils de Lyon: subcutaneous contraceptive implants; ablation; operating room

Study Results

No Results Posted as of Jul 13, 2023