Safe Access: Trial With RemovAid Device

Not Applicable

Completed

• Conditions: Removal of a Contraceptive Subdermal Implant
• Interventions: Device: RemovAid device + lidocaine patch; Device: RemovAid device + lidocaine injection; Procedure: Standard technique + lidocaine injection

• Registration Number: NCT04120337
• Lead Sponsor: RemovAid AS

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).

Study Timeline

• Study First Submitted: 2019-10-01
• Study First Submitted QC: 2019-10-08
• Study First Posted: 2019-10-09
• Study Start: 2019-12-23
• Primary Completion: 2020-11-09
• Status Verified: 2021-02
• Study Completion: 2021-04-01
• Last Update Submitted: 2021-09-22
• Last Update Posted: 2021-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 225

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RemovAid Device + lidocaine patch	RemovAid device + lidocaine patch	Test device with lidocaine patch for local anesthesia
RemovAid Device + lidocaine injection	RemovAid device + lidocaine injection	Test device with lidocaine injection for local anesthesia
Standard removal technique + lidocaine injection	Standard technique + lidocaine injection	Standard technique involves a scalpel, forceps, and tweezers with lidocaine injection for local anesthesia

Primary Outcome Measures

Name	Time	Method
Number of women who have post-removal complications -	4 weeks	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
Number of implants that are successfully removed	0-3 hours	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.

Secondary Outcome Measures

Name	Time	Method
Provider feedback on device on ways the product helped or hindered implant removal	0-3 hours	Text responses on ways the product helped or hindered implant removal
Participant pain level	0-3 hours	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
Provider feedback on device on whether RemovAid device helped with removal of implant	0-3 hours	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
Duration of removal procedure	0-3 hours	Number of minutes and seconds need to remove the implant

Trial Locations

Locations (1)

Kawempe Referral Hospital; 🇺🇬 Kampala, Uganda