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ABLIMCO: Quality of Life After Laparoscopic Removal of Essure®

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Recruiting
CT.gov ID
NCT03281564
Collaborator
(none)
500
Enrollment
1
Location
72
Anticipated Duration (Months)
6.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Quality of life after Essure® removal

Study Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Prospective Study of Quality of Life After Laparoscopic Removal of Essure®
Actual Study Start Date :
Oct 14, 2017
Anticipated Primary Completion Date :
Nov 14, 2022
Anticipated Study Completion Date :
Oct 14, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Quality of life 1 month after laparoscopic removal of Essure® [1 month]

    Questionnaire to assess the quality of life 1 month after laparoscopic removal of Essure® device

Eligibility Criteria

Criteria

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

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:
NCT03281564
Other Study ID Numbers:
  • 69HCL17_0479
First Posted:
Sep 13, 2017
Last Update Posted:
Apr 4, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 4, 2022