Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
225 participants
INTERVENTIONAL
2019-12-23
2021-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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RemovAid Device + lidocaine patch
Test device with lidocaine patch for local anesthesia
RemovAid device + lidocaine patch
The RemovAid device incises the skin and grasps the implant for removal. A lidocaine patch will be used prior to incision.
RemovAid Device + lidocaine injection
Test device with lidocaine injection for local anesthesia
RemovAid device + lidocaine injection
The RemovAid device incises the skin and grasps the implant for removal. A lidocaine injection will be used prior to incision.
Standard removal technique + lidocaine injection
Standard technique involves a scalpel, forceps, and tweezers with lidocaine injection for local anesthesia
Standard technique + lidocaine injection
Using scalpel, tweezers, and forceps to remove a subdermal implant. A lidocaine injection will be used prior to incision.
Interventions
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RemovAid device + lidocaine patch
The RemovAid device incises the skin and grasps the implant for removal. A lidocaine patch will be used prior to incision.
Standard technique + lidocaine injection
Using scalpel, tweezers, and forceps to remove a subdermal implant. A lidocaine injection will be used prior to incision.
RemovAid device + lidocaine injection
The RemovAid device incises the skin and grasps the implant for removal. A lidocaine injection will be used prior to incision.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* Previous failed implant removal
18 Years
99 Years
FEMALE
Yes
Sponsors
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Karolinska Institutet
OTHER
Mulago Hospital, Uganda
OTHER
FHI 360
OTHER
RemovAid AS
INDUSTRY
Responsible Party
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Principal Investigators
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Kristina Gemzell-Danielsson, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Locations
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Kawempe Referral Hospital
Kampala, , Uganda
Countries
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References
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Levine JP, Sinofsky FE, Christ MF; Implanon US Study Group. Assessment of Implanon insertion and removal. Contraception. 2008 Nov;78(5):409-17. doi: 10.1016/j.contraception.2008.06.016. Epub 2008 Sep 18.
Fraser IS. The challenges of location and removal of Implanon contraceptive implants. J Fam Plann Reprod Health Care. 2006 Jul;32(3):151-2. doi: 10.1783/147118906777888459. No abstract available.
Creinin MD, Kaunitz AM, Darney PD, Schwartz L, Hampton T, Gordon K, Rekers H. The US etonogestrel implant mandatory clinical training and active monitoring programs: 6-year experience. Contraception. 2017 Feb;95(2):205-210. doi: 10.1016/j.contraception.2016.07.012. Epub 2016 Jul 21.
Hubacher D, Byamugisha J, Kakaire O, Nalubwama H, Emtell Iwarsson K, Bratlie M, Chen PL, Gemzell-Danielsson K. Removal of a well-palpable one-rod subdermal contraceptive implant using a dedicated hand-held device or standard technique: a randomized, open-label, non-inferiority trial. Hum Reprod. 2022 Sep 30;37(10):2320-2333. doi: 10.1093/humrep/deac179.
Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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2018-103
Identifier Type: -
Identifier Source: org_study_id
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