Quality of Life After Laparoscopic Removal of Essure® (ABLIMCO)

November 10, 2023 updated by: Hospices Civils de Lyon

Prospective Study of Quality of Life After Laparoscopic Removal of Essure®

A lot of patients seem to complain after hysteroscopic tubal occlusion by Essure® device with a worce quality of life. Investigators' hypothesis is that Essure® laparoscopic removal may improve quality of life. This prospectice study aim to assess the quality of life 1, 3, 6 and 12 months after Essure® removal.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

474

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
        • Gynaecology Department, Hôpital Femme Mère Enfant, Hospices Civils de Lyon

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

Sampling Method

Non-Probability Sample

Study Population

Patients with laparoscopic removal of Essure®

Description

Inclusion Criteria:

  • women aged 18 years or more
  • patients with Essure® sterilization device
  • surgical removal of Essure® with bilateral salpingectomy by laparoscopy

Exclusion Criteria:

  • interview revealing disorder entailing unacceptable risk of postoperative complications: coagulation disorder, immune system disorder, evolutive disease, etc.
  • impaired lower-limb range of motion preventing positioning for surgery
  • inability to understand information provided
  • prisoner or under administrative supervision.

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Essure®
Patients with laparoscopic removal of Essure®
Other: Quality of life after Essure® removal
Questionnaire to assess the quality of life 1, 3, 6 and 12 months after laparoscopic removal of Essure® device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life 1 month after laparoscopic removal of Essure®
Time Frame: 1 month
Questionnaire to assess the quality of life 1 month after laparoscopic removal of Essure® device
1 month

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)

October 14, 2017

Primary Completion (Actual)

October 17, 2023

Study Completion (Actual)

October 17, 2023

Study Registration Dates

First Submitted

September 11, 2017

First Submitted That Met QC Criteria

September 11, 2017

First Posted (Actual)

September 13, 2017

Study Record Updates

Last Update Posted (Estimated)

November 13, 2023

Last Update Submitted That Met QC Criteria

November 10, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 69HCL17_0479

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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