NCT03281564

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
474

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 13, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

October 14, 2017

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2023

Completed
Last Updated

November 13, 2023

Status Verified

May 1, 2023

Enrollment Period

6 years

First QC Date

September 11, 2017

Last Update Submit

November 10, 2023

Conditions

Contraceptive Device; ComplicationsQuality of Life

Outcome Measures

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

    1 month

Study Arms (1)

Essure®

Patients with laparoscopic removal of Essure®

Other: Quality of life after Essure® removal

Interventions

Quality of life after Essure® removalOTHER

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

Essure®

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with laparoscopic removal of Essure®

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bron, 69677, France

Location

Related Publications (1)

  • Trecourt A, Devouassoux-Shisheboran M, Nohuz E, Cerruto E, Moret S, Hallez D, Miguet-Bensouda C, Chene G. Clinical and histopathological correlations in symptomatic patients with salpingectomy for Essure(R) implant removal: a cross-sectional study. Eur J Contracept Reprod Health Care. 2023 Aug;28(4):227-233. doi: 10.1080/13625187.2023.2218953. Epub 2023 Jun 27.

    PMID: 37365993DERIVED

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2017

First Posted

September 13, 2017

Study Start

October 14, 2017

Primary Completion

October 17, 2023

Study Completion

October 17, 2023

Last Updated

November 13, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)