Investigation to Evaluate Performance and Safety of RemovAid ™ in Removal of Contraceptive Implants
NCT ID: NCT03912649
Last Updated: 2021-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
15 participants
INTERVENTIONAL
2019-06-11
2020-11-18
Brief Summary
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The primary endpoint of the device is to evaluate the performance of the device, specifically its success rate in removing palpable contraceptive implants. The device shall be able to fixate at least 80% of palpable implants, and successfully remove at least 90% of these implants.
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Detailed Description
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The implant retrieval device aims to standardize and simplify the implant removal procedure. There is no comparator in the investigation. Descriptive data will be recorded, all recruited subjects will be exposed to the investigational medical device (IMD) The primary endpoint is the percentage of fixated implants that are successfully removed without the use of additional tools.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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RemovAid arm
RemovAid arm -
All subjects have their implant removed by the RemovAid device
RemovAid
The RemovAid device is used for removal
Interventions
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RemovAid
The RemovAid device is used for removal
Eligibility Criteria
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Inclusion Criteria
* Willing to remove a palpable subdermal Implanon/ Nexplanon CI
* Willing and able to give written informed consent for participation in the investigation
* Willing to provide follow-up information according to the Clinical Investigators brochure
Exclusion Criteria
* Active skin lesion over the CI.
* The Investigator considers the subject unlikely to comply with investigational procedures, restrictions and requirements.
* Any contraindication for removal of the PI, as judged by the Investigator.
* Any disorders or medications that might affect coagulation, as judged by the Investigator.
* Any conditions suspected to affect healing or increase risk of infection (e.g. keloid tendency, diabetes or any upper arm dermatological condition that may affect upper arm healing)
18 Years
99 Years
FEMALE
No
Sponsors
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Karolinska University Hospital
OTHER
RemovAid AS
INDUSTRY
Responsible Party
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Principal Investigators
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Kristina Gemzell-Danielsson, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Locations
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Karolinska University Hospital
Stockholm, , Sweden
Countries
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References
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Committee on Adolescent Health Care Long-Acting Reversible Contraception Working Group, The American College of Obstetricians and Gynecologists. Committee opinion no. 539: adolescents and long-acting reversible contraception: implants and intrauterine devices. Obstet Gynecol. 2012 Oct;120(4):983-8. doi: 10.1097/AOG.0b013e3182723b7d.
Mansour D, Mommers E, Teede H, Sollie-Eriksen B, Graesslin O, Ahrendt HJ, Gemzell-Danielsson K. Clinician satisfaction and insertion characteristics of a new applicator to insert radiopaque Implanon: an open-label, noncontrolled, multicenter trial. Contraception. 2010 Sep;82(3):243-9. doi: 10.1016/j.contraception.2010.04.007. Epub 2010 May 18.
Mommers E, Blum GF, Gent TG, Peters KP, Sordal TS, Marintcheva-Petrova M. Nexplanon, a radiopaque etonogestrel implant in combination with a next-generation applicator: 3-year results of a noncomparative multicenter trial. Am J Obstet Gynecol. 2012 Nov;207(5):388.e1-6. doi: 10.1016/j.ajog.2012.08.002. Epub 2012 Aug 10.
Webb AM. Why go to Tiger Country? A report of two cases of Implanon removal. J Fam Plann Reprod Health Care. 2006 Jul;32(3):193-4. doi: 10.1783/147118906777888233. No abstract available.
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.
Funk S, Miller MM, Mishell DR Jr, Archer DF, Poindexter A, Schmidt J, Zampaglione E; Implanon US Study Group. Safety and efficacy of Implanon, a single-rod implantable contraceptive containing etonogestrel. Contraception. 2005 May;71(5):319-26. doi: 10.1016/j.contraception.2004.11.007.
Other Identifiers
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REVALID03
Identifier Type: -
Identifier Source: org_study_id
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