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Safe Access: Trial With RemovAid Device

NCT04120337 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2021-09-28

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Karolinska Institutet

    collaborator OTHER

  • Mulago Hospital, Uganda

    collaborator OTHER

  • FHI 360

    collaborator OTHER

  • RemovAid AS

    lead INDUSTRY

Principal Investigators

  • Kristina Gemzell-Danielsson, MD, PhD · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-23
Primary Completion
2020-11-09
Completion
2021-04-01

Countries

  • Uganda

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04120337 on ClinicalTrials.gov