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OpenTrials
Completed

NCT Number: NCT04120337

Safe Access: Trial With RemovAid Device

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).

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Key information

Conditions

Removal of a Contraceptive Subdermal Implant

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kawempe Referral Hospital

Kampala, Uganda

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Standard technique + lidocaine injection

Procedure

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

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.

Primary outcomes

  1. Number of women who have post-removal complications -

    Time frame: 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

  2. Number of implants that are successfully removed

    Time frame: 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 outcomes

  1. Participant pain level

    Time frame: 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

  2. Duration of removal procedure

    Time frame: 0-3 hours

    Number of minutes and seconds need to remove the implant

  3. Provider feedback on device on whether RemovAid device helped with removal of implant

    Time frame: 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

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

    Time frame: 0-3 hours

    Text responses on ways the product helped or hindered implant removal

Sponsors and collaborators

Lead sponsor

RemovAid AS

Industry

Collaborators

  • FHI 360
  • Karolinska Institutet
  • Mulago Hospital, Uganda

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Oct 9, 2019
Registry last updated
Sep 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.