Safe Access: Trial With RemovAid Device

Removal of a Contraceptive Subdermal Implant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04120337
• Other study ID #: 2018-103
• Status: Completed
• Phase: N/A
• Start date: December 23, 2019
• Est. completion date: April 1, 2021

Study information

• Verified date: February 2021
• Source: RemovAid AS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: April 1, 2021
• Est. primary completion date: November 9, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Removal of a Contraceptive Subdermal Implant

Intervention

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.

Procedure:
• Standard technique + lidocaine injection
Using scalpel, tweezers, and forceps to remove a subdermal implant. A lidocaine injection will be used prior to incision.

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.

Locations

Country	Name	City	State
Uganda	Kawempe Referral Hospital	Kampala

Sponsors (4)

Lead Sponsor	Collaborator
RemovAid AS	FHI 360, Karolinska Institutet, Mulago Hospital, Uganda

Country where clinical trial is conducted

Uganda, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Duration of removal procedure	Number of minutes and seconds need to remove the implant	0-3 hours
Secondary	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
Secondary	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