Removal of a Contraceptive Subdermal ImplantNCT04120337
Safe Access: Trial With RemovAid Device
A study testing RemovAid device + lidocaine patch, Standard technique + lidocaine injection and RemovAid device + lidocaine injection in people with Removal of a Contraceptive Subdermal Implant, run by RemovAid AS at 1 site in Uganda.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Removal of a Contraceptive Subdermal Implant
- What is being tested?
- RemovAid device + lidocaine patch, Standard technique + lidocaine injection and RemovAid device + lidocaine injection
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteUganda
- Study dates
- 23 Dec 2019to 1 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Implants that are not easily palpable
- Previous failed implant removal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safe Access: Randomized Trial to Compare Removal Techniques for the One-Rod Subdermal Contraceptive Implant: RemovAid Device Versus Standard Approach
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).
Read the detailed 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).
- Being tested
- RemovAid device + lidocaine patch, Standard technique + lidocaine injection, RemovAid device + lidocaine injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemovAid device + lidocaine patchDevice
The RemovAid device incises the skin and grasps the implant for removal. A lidocaine patch will be used prior to incision.
Standard technique + lidocaine injectionProcedure or surgery
Using scalpel, tweezers, and forceps to remove a subdermal implant. A lidocaine injection will be used prior to incision.
RemovAid device + lidocaine injectionDevice
The RemovAid device incises the skin and grasps the implant for removal. A lidocaine injection will be used prior to incision.
| Study group | Role | What they receive |
|---|---|---|
| RemovAid Device + lidocaine patch | Experimental | Test device with lidocaine patch for local anesthesia Receives: Device: RemovAid device + lidocaine patch |
| RemovAid Device + lidocaine injection | Experimental | Test device with lidocaine injection for local anesthesia Receives: 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 Receives: Procedure: Standard technique + lidocaine injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 0-3 hours
Secondary outcomes (4)
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
Measured: 0-3 hours
Duration of removal procedure
Number of minutes and seconds need to remove the implant
Measured: 0-3 hours
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
Measured: 0-3 hours
Provider feedback on device on ways the product helped or hindered implant removal
Text responses on ways the product helped or hindered implant removal
Measured: 0-3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start23 Dec 2019
- Primary completion9 Nov 2020
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Removal of a Contraceptive Subdermal ImplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- RemovAid AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Karolinska Institutet, Mulago Hospital, Uganda, FHI 360
- Responsible party
- Sponsor
- Investigators
- Kristina Gemzell-Danielsson, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04120337
- Sponsor's protocol ID
- 2018-103
- Status last verified
- Feb 2021
- First submitted
- 1 Oct 2019
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Results and data will be archived in the Norwegian Social Science Data Services (NSD). Data will be made available after the primary results are published.
Publications
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.
PubMed 18929739Fraser 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.
PubMed 16857065Creinin 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.
PubMed 27452317Hubacher 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.
PubMed 35960174
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safe Access: Randomized Trial to Compare Removal Techniques for the One-Rod Subdermal Contraceptive Implant: RemovAid Device Versus Standard Approach
- ClinicalTrials.gov ID
- NCT04120337
- Acronym / sponsor ID
- 2018-103
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- RemovAid ASIndustry (pharma, biotech, devices)
- Collaborators
- Karolinska Institutet, Mulago Hospital, Uganda, FHI 360
- Study start
- 23 Dec 2019 (actual)
- Primary completion
- 9 Nov 2020 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 9 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RemovAid Device + lidocaine patch | Experimental | Device: RemovAid device + lidocaine patchTest device with lidocaine patch for local anesthesia |
| RemovAid Device + lidocaine injection | Experimental | Device: RemovAid device + lidocaine injectionTest device with lidocaine injection for local anesthesia |
| Standard removal technique + lidocaine injection | Active comparator | Procedure: Standard technique + lidocaine injectionStandard technique involves a scalpel, forceps, and tweezers with lidocaine injection for local anesthesia |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- Implants that are not easily palpable
- Previous failed implant removal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemovAid device + lidocaine patchThe RemovAid device incises the skin and grasps the implant for removal. A lidocaine patch will be used prior to incision. | Device | RemovAid Device + lidocaine patch |
| Standard technique + lidocaine injectionUsing scalpel, tweezers, and forceps to remove a subdermal implant. A lidocaine injection will be used prior to incision. | Procedure or surgery | Standard removal technique + lidocaine injection |
| RemovAid device + lidocaine injectionThe RemovAid device incises the skin and grasps the implant for removal. A lidocaine injection will be used prior to incision. | Device | RemovAid Device + lidocaine injection |
Primary outcome
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
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.
4 secondary outcomes
Participant pain level
Time frame: 0-3 hours
Duration of removal procedure
Time frame: 0-3 hours
Provider feedback on device on whether RemovAid device helped with removal of implant
Time frame: 0-3 hours
Provider feedback on device on ways the product helped or hindered implant removal
Time frame: 0-3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Background: PubMed 18929739Levine 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.
- Background: PubMed 16857065Fraser 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.
- Background: PubMed 27452317Creinin 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.
- Derived from this study: PubMed 35960174Hubacher 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.
- Individual participant dataSharing planned: Yes. Results and data will be archived in the Norwegian Social Science Data Services (NSD). Data will be made available after the primary results are published.
Related trials for Removal of a Contraceptive Subdermal Implant
Recruiting
PLACE Trial: Preserving Long-Acting Contraception Through Education
Contraception
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristina Gemzell-Danielsson, MD, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RemovAid device + lidocaine patch, Standard technique + lidocaine injection and RemovAid device + lidocaine injection in people with Removal of a Contraceptive Subdermal Implant, run by RemovAid AS at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of women who have post-removal complications - (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04120337, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.