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CompletedNCT03281564ABLIMCOUpdated Nov 13, 2023

Quality of Life After Laparoscopic Removal of Essure®

An observational study in Contraceptive Device; Complications and Quality of Life, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-13.

Sponsored by Hospices Civils de Lyon · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
474
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Contraceptive Device; Complications
  • Quality of Life
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with laparoscopic removal of Essure®

Inclusion criteria

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

Exclusion criteria

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.
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
474 participants (actual)
Patient registry
No

Groups and cohorts

  • Essure®

    Patients with laparoscopic removal of Essure®

    Other: Quality of life after Essure® removal

Interventions

  • OtherQuality of life after Essure® removal

    Questionnaire to assess the quality of life 1, 3, 6 and 12 months after laparoscopic removal of Essure® device

05

What researchers measure

Primary outcomes

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

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

    Time frame: 1 month

06

Study locations

1 site
  • Gynaecology Department, Hôpital Femme Mère Enfant, Hospices Civils de Lyon
    Bron, 69677, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03281564
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Sep 13, 2017
Start date
Oct 14, 2017
Primary completion
Oct 17, 2023
Completion
Oct 17, 2023
Last update
Nov 13, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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