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Removal of Palpable Subdermal Contraceptive Rod Implants.

NCT02986971 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2017-11-21

No results posted yet for this study

Summary

There are no implant removal devices on the market by any manufacturer. New features are described in comparison with the existing removal technique. Overall, the RemovAid™ combines the features of fixation, incision and extraction. This combination of functions has not previously been combined in a single device.

The investigators wish to perform this pilot clinical investigation with the aim to demonstrate that the Investigational Medical Device (IMD), RemovAid ™, may safely and effectively facilitate implant removal. Other aims are to show that the IMD have the potential to reduce procedure length variability, reduce procedural complexity and reduce the need for additional procedural equipment related to CI removal procedures, without causing any harm to the subject.

Conditions

  • Removal of Contraceptive Implant

Interventions

DEVICE

New IMD

The contraceptive implants of the subjects in this arm are removed by the new IMD.

Sponsors & Collaborators

  • Karolinska University Hospital

    collaborator OTHER

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • The Research Council of Norway

    collaborator OTHER

  • Amano Clinical Consulting AB

    collaborator OTHER

  • RemovAid AS

    lead INDUSTRY

Principal Investigators

  • Marte Bratlie, MD · RemovAid AS

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-11
Primary Completion
2017-05-19
Completion
2017-09-15

Countries

  • Sweden

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 NCT02986971 on ClinicalTrials.gov