Safe Access: Trial With RemovAid Device

RemovAid

Status: Completed

Conditions: Removal of a Contraceptive Subdermal Implant

Treatments: Device: RemovAid device + lidocaine patch; Procedure: Standard technique + lidocaine injection; Device: RemovAid device + lidocaine injection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04120337

2018-103

Details and patient eligibility

About

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).

Full 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).

Enrollment: 225 patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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225 participants in 3 patient groups

RemovAid Device + lidocaine patch

Experimental group

Description:

Test device with lidocaine patch for local anesthesia

Treatment:

Device: RemovAid device + lidocaine patch

RemovAid Device + lidocaine injection

Experimental group

Description:

Test device with lidocaine injection for local anesthesia

Treatment:

Device: RemovAid device + lidocaine injection

Standard removal technique + lidocaine injection

Active Comparator group

Description:

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

Treatment:

Procedure: Standard technique + lidocaine injection