Safe Access: Trial With RemovAid Device

Study Overview
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Brief Summary
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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
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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).

Official Title
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Safe Access: Randomized Trial to Compare Removal Techniques for the One-Rod Subdermal Contraceptive Implant: RemovAid Device Versus Standard Approach

Conditions
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Removal of a Contraceptive Subdermal Implant

Intervention / Treatment
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* Device: RemovAid device + lidocaine patch
* Procedure: Standard technique + lidocaine injection
* Device: RemovAid device + lidocaine injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RemovAid Device + lidocaine patch<br>Test device with lidocaine patch for local anesthesia | Device: RemovAid device + lidocaine patch<br>* The RemovAid device incises the skin and grasps the implant for removal. A lidocaine patch will be used prior to incision.<br>|
| Experimental: RemovAid Device + lidocaine injection<br>Test device with lidocaine injection for local anesthesia | Device: RemovAid device + lidocaine injection<br>* The RemovAid device incises the skin and grasps the implant for removal. A lidocaine injection will be used prior to incision.<br>|
| Active Comparator: Standard removal technique + lidocaine injection<br>Standard technique involves a scalpel, forceps, and tweezers with lidocaine injection for local anesthesia | Procedure: Standard technique + lidocaine injection<br>* Using scalpel, tweezers, and forceps to remove a subdermal implant. A lidocaine injection will be used prior to incision.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 0-3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 0-3 hours | 
| Duration of removal procedure | Number of minutes and seconds need to remove the implant | 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 | 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 | 0-3 hours |