Laparoscopic Essure Device Removal

Contraception Clinical Trial

— ESSURE  

Official title:

Essure Removal for Device-attributed Symptoms: Quality of Life Evaluation Before and After Surgical Removal

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04779658
• Other study ID #: RECHMPL21_0087
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: February 2021
• Source: University Hospital, Montpellier
• Contact: GAUTHIER RATHAT
• Phone: 467336421
• Email: g-rathat[@]chu-montpllier.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In recent years, several symptoms have been attributed to Essure, including pelvic pain and other general symptoms. Consequently, an increasing number of patients request Essure removal for alleged adverse reactions to the device.

Study Objective: To evaluate the quality of life of patients who underwent Essure_ device removal and morbidity of this surgery.

Design: Prospective observational cohort study. Setting: Academic hospitals of La Conception, Marseille, and Arnaud-de-Villeneuve, Montpellier, France.

Patients: Women who underwent Essure_ device removal by salpingectomy, between February 2017 and August 2018.

Methods : The following information have been collected during preoperative clinics:

demographic data, medical history, clinical symptoms attributed to the Essure device, time between Essure sterilization and early symptoms, time between the beginning of symptoms and surgical removal. Follow-up visits have benne scheduled at one month and three months post-operation. The evolution of symptoms was collected during the follow-up visit at three months based on clinical reports and a dedicated questionnaire. Evaluation of Quality of life have been evaluated thanks to SF36 and HAD questionnaires. Alle these patients will be contacted by phone call to assess to evolution of symptoms and to complete SF 36 and HAD questionnaires.

Hypothesis : Recovery of symptoms due to ESSURE device and improvement of quality of life after surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 30, 2021
• Est. primary completion date: December 29, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• age >18 years old

• symptoms related to ESSURE device

• salpingectomy for ESSURE removal

Exclusion criteria:

• Exclusion criteria were failure to perform a complete removal of the Essure and second surgery to remove fragments left behind from a previous procedure.

Related Conditions & MeSH terms

• Contraception

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of quality of life after ESSURE removal	Evaluation of quality of life after ESSURE removal by SF 36 questionnaire Preoperative questionnaires will be collected from medical record. Patients will be contacted by phone call to answer to this questionnaire for the long term follow-up	Preoperative
Primary	Evaluation of quality of life after ESSURE removal	Evaluation of quality of life after ESSURE removal by SF 36 questionnaire three-months post-operative questionnaires will be collected from medical record. Patients will be contacted by phone call to answer to this questionnaire for the long term follow-up	three-months post-operative
Secondary	Evaluation of morbidity of ESSURE removal	description of per et postoperative complications (patient's medical record and by phone call)	1 day