Safe Access: Trial With RemovAid Device

NCT04120337 | Completed

• 1 other identifier: 2018-103
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

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).

Conditions

Removal of a Contraceptive Subdermal Implant

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Participant pain level

  0-3 hours

• Duration of removal procedure

  0-3 hours

• Provider feedback on device on whether RemovAid device helped with removal of implant

  0-3 hours

• Provider feedback on device on ways the product helped or hindered implant removal

  0-3 hours

Study Arms (3)

RemovAid Device + lidocaine patch

EXPERIMENTAL

Test device with lidocaine patch for local anesthesia

Device: RemovAid device + lidocaine patch

RemovAid Device + lidocaine injection

EXPERIMENTAL

Test device with lidocaine injection for local anesthesia

Device: RemovAid device + lidocaine injection

Standard removal technique + lidocaine injection

ACTIVE COMPARATOR

Standard technique involves a scalpel, forceps, and tweezers with lidocaine injection for local anesthesia

Procedure: Standard technique + lidocaine injection

Interventions

RemovAid device + lidocaine patch DEVICE

The RemovAid device incises the skin and grasps the implant for removal. A lidocaine patch will be used prior to incision.

RemovAid Device + lidocaine patch

Standard technique + lidocaine injection PROCEDURE

Using scalpel, tweezers, and forceps to remove a subdermal implant. A lidocaine injection will be used prior to incision.

Standard removal technique + lidocaine injection

RemovAid device + lidocaine injection DEVICE

The RemovAid device incises the skin and grasps the implant for removal. A lidocaine injection will be used prior to incision.

RemovAid Device + lidocaine injection

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Implants that are not easily palpable
• Previous failed implant removal

Sponsors & Collaborators

• RemovAid AS: lead
• Karolinska Institutet: collaborator
• Mulago Hospital, Uganda: collaborator
• FHI 360: collaborator

Study Sites (1)

Kawempe Referral Hospital

Kampala, Uganda

Location

Related Publications (4)

• 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.

  PMID: 18929739 BACKGROUND

• 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.

  PMID: 16857065 BACKGROUND

• 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.

  PMID: 27452317 BACKGROUND

• 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.

  PMID: 35960174 DERIVED

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Kristina Gemzell-Danielsson, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: October 9, 2019
• Study Start: December 23, 2019
• Primary Completion: November 9, 2020
• Study Completion: April 1, 2021
• Last Updated: September 28, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: Within 24 months after trial completion
• Access Criteria: open

Locations

UG (1)