Investigation to Evaluate Performance and Safety of RemovAid ™ in Removal of Contraceptive Implants

NCT03912649 | Terminated

• 1 other identifier: REVALID03
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Removal Contraceptive Implant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

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

  1 week

• Pain during procedure: Visual Analogue Scale

  15 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

RemovAid arm - All subjects have their implant removed by the RemovAid device

Device: RemovAid

Interventions

RemovAid DEVICE

The RemovAid device is used for removal

RemovAid arm

Eligibility Criteria

• Age: 18 Years - 99 Years
• 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

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

Study Officials

• Kristina Gemzell-Danielsson, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 11, 2019
• Study Start: June 11, 2019
• Primary Completion: November 18, 2020
• Study Completion: November 18, 2020
• Last Updated: February 3, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)