Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:56 PM
Study NCT ID:
NCT04779658
Status:
UNKNOWN
Last Update Posted:
2021-03-03
First Post:
2021-02-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Laparoscopic Essure Device Removal
Sponsor:
University Hospital, Montpellier
Organization:
Study Overview
Official Title:
Essure Removal for Device-attributed Symptoms: Quality of Life Evaluation Before and After Surgical Removal
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESSURE
Brief Summary:
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 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: