Laparoscopic Essure Device Removal (ESSURE)

March 2, 2021 updated by: University Hospital, Montpellier

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

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

90

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

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of quality of life after ESSURE removal
Time Frame: Preoperative
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
Evaluation of quality of life after ESSURE removal
Time Frame: three-months post-operative
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of morbidity of ESSURE removal
Time Frame: 1 day
description of per et postoperative complications (patient's medical record and by phone call)
1 day

Collaborators and Investigators

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

Sponsor

University Hospital, Montpellier

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)

January 1, 2021

Primary Completion (ANTICIPATED)

December 29, 2021

Study Completion (ANTICIPATED)

December 30, 2021

Study Registration Dates

First Submitted

February 18, 2021

First Submitted That Met QC Criteria

March 2, 2021

First Posted (ACTUAL)

March 3, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 3, 2021

Last Update Submitted That Met QC Criteria

March 2, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RECHMPL21_0087

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

NC

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.

Clinical Trials on Contraception

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe