Removal Contraceptive Implant Clinical Trial
— REVALID03Official title:
A Prospective, Single-centre, Non-comparative Feasibility Investigation to Evaluate Performance and Safety of RemovAid ™ Retrieval Device When Used for Removal of Palpable Subdermal Contraceptive Rod Implants
| Verified date | January 2021 |
| Source | RemovAid AS |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The safety and efficacy of a subdermal implant retrieval device (RemovAid) is investigated in a population of 25 women seeking removal of their palpable contraceptive implants. 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.
| Status | Terminated |
| Enrollment | 15 |
| Est. completion date | November 18, 2020 |
| Est. primary completion date | November 18, 2020 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 99 Years |
| Eligibility | Inclusion Criteria: - Female age 18 or older - 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: - Known allergy to local anaesthetic (lidocaine/lignocaine) or disinfectant (chlorhexidine). - 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) |
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Karolinska University Hospital | Stockholm |
| Lead Sponsor | Collaborator |
|---|---|
| RemovAid AS | Karolinska University Hospital |
Sweden,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Mommers E, Blum GF, Gent TG, Peters KP, Sørdal 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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Successful removal of implant | The percentage of fixated implants that are successfully removed by the device without the use of additional tools | 15 minutes | |
| Secondary | Frequency, severity, causality and outcome of adverse events (AEs) | Both Anticipated and unanticipated AEs will be recorded, both immediately following the intervention and at follow-up | 1 week | |
| Secondary | Pain during procedure: Visual Analogue Scale | Mean pain score (maximum pain intensity during the procedure) indicated by the subject on a Visual Analogue Scale 0-100 mm ruler, assuming that anaesthesia has been properly administered. Higher values represent a worse outcome. | 15 minutes | |
| Secondary | Success of fixation of implant | Percentage of palpable implants where the implant could be seen and/or felt on both sides of the clamp after maximum three attempts of fixation. 80% or more is considered success. | 5 minutes | |
| Secondary | Duration of procedure | Mean time from making incision until implant is removed, and first touching subject with the device until implant extracted | 25 minutes | |
| Secondary | Technical functionality of device determined by an operators questionnaire | Fulfilment of pre-defined technical requirements, as documented on an operator functionality questionnaire. The questionnaire consists of a range of yes/no questions to device functionality | 5 minutes | |
| Secondary | Operators impression of the device | The operator's global impression of the IMD will be assessed using a scale 1-5, where 5 is excellent and 1= poor | 5 minutes | |
| Secondary | Subject satisfaction: 5- point scale | The subject's global assessment of satisfaction with the procedure will be assessed using a scale of 1-5, where 5 is excellent | 5 minutes |