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| Name | Class |
|---|---|
| Karolinska Institutet | OTHER |
| Mulago Hospital, Uganda | OTHER |
| FHI 360 | OTHER |
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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RemovAid Device + lidocaine patch | Experimental | Test device with lidocaine patch for local anesthesia |
|
| RemovAid Device + lidocaine injection | Experimental | Test device with lidocaine injection for local anesthesia |
|
| Standard removal technique + lidocaine injection | Active Comparator | Standard technique involves a scalpel, forceps, and tweezers with lidocaine injection for local anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 0-3 hours |
| Duration of removal procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristina Gemzell-Danielsson, MD, PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kawempe Referral Hospital | Kampala | Uganda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18929739 | Background | 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. | |
| 16857065 | 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. |
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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.
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Within 24 months after trial completion
open
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | May 28, 2019 | Oct 1, 2019 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| 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. |
|
Number of minutes and seconds need to remove the implant
| 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 | 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 | 0-3 hours |
| 27452317 | 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. |
| 35960174 | Derived | 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. |
| Aniline Compounds |
| D000588 | Amines |