Pilot Removal of Palpable Subdermal Contraceptive Rod Implants (REVALID02)

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.

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.

Study Overview

• Status: Terminated
• Conditions: Removal of Contraceptive Implant
• Intervention / Treatment: Device: RemovAid device

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 17176
    • Karolinska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RemovAid arm; New IMD Subjects with contraceptive implants to be removed, are subjected to the novel device by personnel skilled in traditional removal.	Device: RemovAid device; The contraceptive implants of the subjects in this arm are removed by the new IMD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful removal of implant .	Percentage of fixated implants that were successfully removed without the use of additional tools	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain during procedure	Mean pain score (maximum pain intensity during the procedure) indicated by the subject on a Visual Analogue Scale (VAS) 0-100 mm ruler, assuming that anaesthesia has been properly administered.	5 minutes
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
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
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	5 minutes
Duration of procedure	Mean time from making incision until implant is removed. first handling the device until closing the wound.	25 minutes
Operators impression of the device	The operator's global impression of the IMD will be assessed using a 5-point scale, where 5 is excellent	5 minutes
Subject satisfaction	The subject's global assessment of satisfaction with the procedure will be assessed using a 5- point scale, where 5 is excellent	Time Frame: 5 minutes

Collaborators and Investigators

• Sponsor: RemovAid AS
• Collaborators: Karolinska University Hospital; The Research Council of Norway; Bill and Melinda Gates Foundation; Amano Clinical Consulting AB

Publications and helpful links

General Publications

• 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.

Helpful Links

• World Health Organization. 2014

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2017
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): September 4, 2018

Study Registration Dates

• First Submitted: November 20, 2017
• First Submitted That Met QC Criteria: November 22, 2017
• First Posted (Actual): November 29, 2017

Study Record Updates

• Last Update Posted (Actual): October 18, 2018
• Last Update Submitted That Met QC Criteria: October 17, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Contraceptive Implant
• Other Study ID Numbers: REVALID02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No