An interventional study of RemovAid device + lidocaine patch and Standard technique + lidocaine injection in Removal of a Contraceptive Subdermal Implant, sponsored by RemovAid AS. Completed at 1 site in Uganda. Open to female participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-28.
Sponsored by RemovAid AS · Not applicable, Interventional, and Treatment
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).
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).
RemovAid AS is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Test device with lidocaine patch for local anesthesia
Device: RemovAid device + lidocaine patch
Test device with lidocaine injection for local anesthesia
Device: RemovAid device + lidocaine injection
Standard technique involves a scalpel, forceps, and tweezers with lidocaine injection for local anesthesia
Procedure: Standard technique + lidocaine injection
The RemovAid device incises the skin and grasps the implant for removal. A lidocaine patch will be used prior to incision.
Using scalpel, tweezers, and forceps to remove a subdermal implant. A lidocaine injection will be used prior to incision.
The RemovAid device incises the skin and grasps the implant for removal. A lidocaine injection will be used prior to incision.
Number of women who have post-removal complications -
Complications will include unusual level of trauma to the skin (bruising/hematoma), excessive bleeding, use of sutures to repair skin after removal, inability to remove the implant, implant breakage or severing at time of removal, subsequent infection at the removal site, and other complications that may be noted by the investigator
Time frame: 4 weeks
Number of implants that are successfully removed
The number of implants successfully removed i) without breaking the implant and without additional tools (scalpel, tweezers, or forceps), ii) without additional tools, iii) without the additional use of a scalpel.
Time frame: 0-3 hours
Participant pain level
Level of pain as recorded on 10cm visual analog scale from 0cm (No Pain) to 10cm (Worse Pain Imaginable) with higher numbers indicating worse outcomes
Time frame: 0-3 hours
Duration of removal procedure
Number of minutes and seconds need to remove the implant
Time frame: 0-3 hours
Provider feedback on device on whether RemovAid device helped with removal of implant
5-point Likert scale measuring from 1(Strongly Disagree), 2 (Disagree), 3 (Neutral), 4 (Agree), 5 (Strongly Agree) on whether RemovAid device helped with removal of implant with higher scores indicating better outcomes
Time frame: 0-3 hours
Provider feedback on device on ways the product helped or hindered implant removal
Text responses on ways the product helped or hindered implant removal
Time frame: 0-3 hours
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Results and data will be archived in the Norwegian Social Science Data Services (NSD). Data will be made available after the primary results are published.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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