Quality of Life Assessment Before and After Essure Removal

CompletedOBSERVATIONAL
Enrollment

95

Participants

Timeline

Start Date

January 10, 2017

Primary Completion Date

January 31, 2018

Study Completion Date

November 16, 2018

Conditions
Patients Presenting Essure Device Attributed Symptoms
Interventions
BEHAVIORAL

SF-36

Evaluation of the quality of life with an auto-questionnaire validated, with 8 dimensions: physical activity ; limitations due to physical condition; physical pain; perceived health; vitality; life and relationship with others; limitations due to physical condition; psychic health as well as the assessment of perceived health compared to a year ago. Evaluation done pre-operatively, at M1 and M3

BEHAVIORAL

HAD

Evaluation of anxiety and depression with a scale validated with 14 items assess between 0 and 3. Evaluation done pre-operatively and at M3.

OTHER

ANSM

Additional information requested by the ANSM (french National Agency for Medicines and Health Products Safety) following a materiovigilance report. Evaluation done pre-operatively and at M3.

Trial Locations (2)

13005

Public Assistance - Marseille Hospitals, Marseille

34295

Montpellier University Hospital, Montpellier

All Listed Sponsors
collaborator

La Conception Hospital - Marseille - France

UNKNOWN

collaborator

Public Assistance - Marseille Hospitals

UNKNOWN

collaborator

Aix Marseille Université

OTHER

lead

University Hospital, Montpellier

OTHER

NCT03401437 - Quality of Life Assessment Before and After Essure Removal | Biotech Hunter | Biotech Hunter