Status:
TERMINATED
Pilot Removal of Palpable Subdermal Contraceptive Rod Implants
Lead Sponsor:
RemovAid AS
Collaborating Sponsors:
Karolinska University Hospital
Bill and Melinda Gates Foundation
Conditions:
Removal of Contraceptive Implant
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
There are no implant removal devices on the market by any manufacturer. Overall, the RemovAid™ combines the features of fixation, incision and extraction. This combination of functions has not previou...
Detailed Description
Detailed Description: Contraceptive Implants (CIs) were introduced to the commercial market in the early 1980s. They are advocated as a safe and effective method of contraception, and are included on...
Eligibility Criteria
Inclusion
- Female age 18 or older
- Willing to remove a palpable subdermal Implanon/ Nexplanon CI
- Willing and able to give written informed consent for participation in the investigation
- Willing to provide follow-up information according to the Clinical Investigators brochure
Exclusion
- Known allergy to local anaesthetic (lidocaine/lignocaine) or disinfectant (chlorhexidine).
- Active skin lesion over the CI.
- The Investigator considers the subject unlikely to comply with investigational procedures, restrictions and requirements.
- Any contraindication for removal of the PI, as judged by the Investigator.
- Any disorders or medications that might affect coagulation, as judged by the Investigator.
- Any conditions suspected to affect healing or increase risk of infection (e.g. keloid tendency, diabetes or any upper arm dermatological condition that may affect upper arm healing)
Key Trial Info
Start Date :
December 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 4 2018
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT03356119
Start Date
December 12 2017
End Date
September 4 2018
Last Update
October 18 2018
Active Locations (1)
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1
Karolinska University Hospital
Stockholm, Sweden, 17176