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Quality of Life Assessment Before and After Essure Removal

NCT03401437 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 95

Last updated 2019-01-04

No results posted yet for this study

Summary

To evaluate quality of life before and after laparoscopic removal of the Essure® system. Women who complain about symptoms attributed to the Essure® device are expected to have an improved quality of life postoperatively.

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.

Sponsors & Collaborators

  • La Conception Hospital - Marseille - France

    collaborator UNKNOWN

  • Public Assistance - Marseille Hospitals

    collaborator UNKNOWN

  • Aix Marseille Université

    collaborator OTHER

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • PATRICE PC CROCHET, PhD · University Hospital, Montpellier

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-10
Primary Completion
2018-01-31
Completion
2018-11-16

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03401437 on ClinicalTrials.gov