Safe Access: Trial With RemovAid Device

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

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).

Study Overview

• Status: Completed
• Conditions: Removal of a Contraceptive Subdermal Implant
• Intervention / Treatment: Device: RemovAid device + lidocaine patch; Device: RemovAid device + lidocaine injection; Procedure: Standard technique + lidocaine injection

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 Type: Interventional
• Enrollment (Actual): 225
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uganda
  • Kampala, Uganda
    • Kawempe Referral Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: RemovAid Device + lidocaine patch; Test device with lidocaine patch for local anesthesia	Device: 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.
EXPERIMENTAL: RemovAid Device + lidocaine injection; Test device with lidocaine injection for local anesthesia	Device: 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.
ACTIVE_COMPARATOR: Standard removal technique + lidocaine injection; Standard technique involves a scalpel, forceps, and tweezers with lidocaine injection for local anesthesia	Procedure: Standard technique + lidocaine injection; Using scalpel, tweezers, and forceps to remove a subdermal implant. A lidocaine injection will be used prior to incision.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: RemovAid AS
• Collaborators: Karolinska Institutet; FHI 360; Mulago Hospital, Uganda

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 23, 2019
• Primary Completion (ACTUAL): November 9, 2020
• Study Completion (ACTUAL): April 1, 2021

Study Registration Dates

• First Submitted: October 1, 2019
• First Submitted That Met QC Criteria: October 8, 2019
• First Posted (ACTUAL): October 9, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 22, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 2018-103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Within 24 months after trial completion
• IPD Sharing Access Criteria: open

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No