Clinical trial NCT03356119: Pilot Removal of Palpable Subdermal Contraceptive Rod Implants
Official 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Removal of Contraceptive Implant
Keywords: Contraceptive Implant
Lead sponsor: RemovAid AS
Sponsor class: INDUSTRY
Collaborators: name: Karolinska University Hospital
name: Bill and Melinda Gates Foundation
name: The Research Council of Norway
name: Amano Clinical Consulting AB
First posted: 2017-11-29
Enrollment: 19
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All recruited subjects will be assigned to implant removal using the RemovAid IMD. There is no formal comparator in this study. The investigators are investigating design functionality and safety.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: There are no implant removal devices on the market by any manufacturer. Overall, the RemovAid™ combines the features of fixation, incision and extraction. This combination of functions has not previously been combined in a single device.

The investigators wish to perform this pilot clinical investigation with the aim to demonstrate that the Investigational Medical Device (IMD), RemovAid ™, may safely and effectively facilitate implant removal. Other aims are to show that the IMD have the potential to reduce procedure length variability, reduce procedural complexity and reduce the need for additional procedural equipment related to CI removal procedures, without causing any harm to the subject.

Detailed description: Detailed Description:

Contraceptive Implants (CIs) were introduced to the commercial market in the early 1980s. They are advocated as a safe and effective method of contraception, and are included on the WHO's Essential Medicines list.

CI manufacturers have focused intense efforts on making insertion of CIs easier, but have largely left CI removals untouched and at the mercy of the various service providers. Different introducers and trocars are available for use with the different CI systems available internationally, and a second generation, single-use trocar is supplied with the Nexplanon® implant system available in Sweden. This second generation trocar has reduced the number of misplaced or deeply inserted CIs, and underlines the benefits of standardizing minor surgical procedures through the use of dedicated medical devices.

The CI removal procedure recommendations have remained essentially unchanged for 40 years, relying on scalpels, forceps and general surgical skills from the service provider. Currently, no standardized technique for removal of CIs exists, and no dedicated CI removal device is found on the commercial market.

Removal of palpable subdermal implants is generally a simple, minor surgical office procedure. However, the procedure for implant removal requires more training and skill than the procedure for insertion. There is a risk of slippage of the scalpel blade or a sudden movement by the client causing inadvertent deeper penetration, in which case any underlying structure could be affected.

Mean removal times, from time of incision until removal of the rod, are consistently reported as less than four minutes, however with ranges from 0.2 - 60 minutes.

Available research shows that the procedure length of the current CI removal procedure is highly variable and reliant on individual operator skills.

Eligibility criteria: 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)

Primary outcomes:
measure: Successful removal of implant .
timeFrame: 15 minutes
Secondary outcomes:
measure: Frequency, severity, causality and outcome of adverse events (AEs)
timeFrame: 1 week
measure: Pain during procedure
timeFrame: 5 minutes
measure: Success of fixation of implant
timeFrame: 5 minutes
measure: Duration of procedure
timeFrame: 25 minutes
measure: Technical functionality of device determined by an operators questionnaire
timeFrame: 5 minutes
measure: Operators impression of the device
timeFrame: 5 minutes
measure: Subject satisfaction
timeFrame: Time Frame: 5 minutes
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
References:
citation: 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.
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.
citation: 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.
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. doi: 10.1783/147118906777888233. No abstract available.
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.
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. doi: 10.1016/j.contraception.2004.11.007.