Clinical trial NCT04120337: Safe Access: Trial With RemovAid Device
Official title: Safe Access: Randomized Trial to Compare Removal Techniques for the One-Rod Subdermal Contraceptive Implant: RemovAid Device Versus Standard Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Removal of a Contraceptive Subdermal Implant
Lead sponsor: RemovAid AS
Sponsor class: INDUSTRY
Collaborators: name: Karolinska Institutet
name: Mulago Hospital, Uganda
name: FHI 360
First posted: 2019-10-09
Enrollment: 225
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 (RemovAid) that incises the skin and grasps the implant for extraction. Safety and efficacy endpoints will be compared to the traditional removal approach (scalpel, forceps, tweezers).

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 different arms will be compared. Efficacy (successful implant removal) will be the secondary comparisons. Finally, pain during removal and duration of removal procedure will be compared. Participants will return to the clinic within 4 weeks of the removal procedure to record the healing process and final interventions (if any).

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* Implants that are not easily palpable
* Previous failed implant removal

Primary outcomes:
measure: Number of women who have post-removal complications -
timeFrame: 4 weeks
measure: Number of implants that are successfully removed
timeFrame: 0-3 hours
Secondary outcomes:
measure: Participant pain level
timeFrame: 0-3 hours
measure: Duration of removal procedure
timeFrame: 0-3 hours
measure: Provider feedback on device on whether RemovAid device helped with removal of implant
timeFrame: 0-3 hours
measure: Provider feedback on device on ways the product helped or hindered implant removal
timeFrame: 0-3 hours
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Kawempe Referral Hospital
Study officials:
affiliation: Karolinska Institutet
name: Kristina Gemzell-Danielsson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.