Re-Essure study

Re-Essure study; a observational study for adverse advents after hysteroscopic Essure sterilization

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON29147

Enrollment

3000

Registered

2017-01-11

Start date

2017-03-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essure, sterilization, implants, nickel

Interventions

Participating women receive 4 questionnaires. The first will be send after their first visit followed by a second two months after the first visit to evaluate change in symptoms over time. The third a

Eligibility

Inclusion criteria

Inclusion criteria: All women with Essure implants

Exclusion criteria

Exclusion criteria: Women who do not want to participate

Design outcomes

Primary

Measure	Time frame
symptom reduction at 12 months after removal.	—

Secondary

Measure	Time frame
Quality of life (SF36) and satisfaction.	—

Contacts

Public ContactDM van Gastel

Máxima Medisch Centrum Verloskunde en Gynaecologie

danielle_vangastel@hotmail.com040-8888000

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)