Status:
COMPLETED
Safe Access: Trial With RemovAid Device
Lead Sponsor:
RemovAid AS
Collaborating Sponsors:
Karolinska Institutet
Mulago Hospital, Uganda
Conditions:
Removal of a Contraceptive Subdermal Implant
Eligibility:
FEMALE
18-99 years
Phase:
NA
Brief Summary
This randomized trial will compare different approaches to removing a subdermal contraceptive implant from the upper arm of 225 women in Uganda. The experimental approach is a hand-held device (RemovA...
Detailed Description
The trial assigns participants to one of three arms: RemovAid+lidocaine patch (n=75), RemovAid+lidocaine injection (n=75) or traditional approach+lidocaine injection(n=75). Complication rates in the d...
Eligibility Criteria
Inclusion
- seeking voluntary removal of a one-rod subdermal implant
- willing to sign an informed consent document
- willing to be randomized to the new device vs. standard technique
- willing to follow-up at the study clinic for any subsequent removal-related complications
- willing to have any follow-up complications recorded and shared
- has an implant that is completely and easily palpable
- has an implant that is easily pinched and lifted
- no known allergies to skin preparation products or local anesthetics
Exclusion
- Implants that are not easily palpable
- Previous failed implant removal
Key Trial Info
Start Date :
December 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2021
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT04120337
Start Date
December 23 2019
End Date
April 1 2021
Last Update
September 28 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Kawempe Referral Hospital
Kampala, Uganda