Pilot Removal of Palpable Subdermal Contraceptive Rod Implants

NCT03356119 | Terminated

• 1 other identifier: REVALID02
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Removal of Contraceptive Implant

Keywords

Contraceptive Implant

Outcome Measures

Primary Outcomes (1)

• Successful removal of implant .

  Percentage of fixated implants that were successfully removed without the use of additional tools

  15 minutes

Secondary Outcomes (7)

• Frequency, severity, causality and outcome of adverse events (AEs)

  1 week

• Pain during procedure

  5 minutes

• Success of fixation of implant

  5 minutes

• Duration of procedure

  25 minutes

• Technical functionality of device determined by an operators questionnaire

  5 minutes

Study Arms (1)

RemovAid arm

EXPERIMENTAL

New IMD Subjects with contraceptive implants to be removed, are subjected to the novel device by personnel skilled in traditional removal.

Device: RemovAid device

Interventions

RemovAid device DEVICE

The contraceptive implants of the subjects in this arm are removed by the new IMD.

RemovAid arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only females use contraceptive implants.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

Karolinska University Hospital

Stockholm, 17176, Sweden

Location

Related Publications (6)

• 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.

  PMID: 22996129 BACKGROUND

• 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.

  PMID: 20705152 BACKGROUND

• 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.

  PMID: 22939402 BACKGROUND

• 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.

  PMID: 16857083 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.

  PMID: 18929739 BACKGROUND

• 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.

  PMID: 15854630 BACKGROUND

Related Links

• World Health Organization. 2014

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: November 29, 2017
• Study Start: December 12, 2017
• Primary Completion: May 1, 2018
• Study Completion: September 4, 2018
• Last Updated: October 18, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)