Investigation to Evaluate Performance and Safety of RemovAid ™ in Removal of Contraceptive Implants (REVALID03)

• ClinicalTrials.gov Identifier: NCT03912649
• Recruitment Status: Not yet recruiting
• First Posted: April 11, 2019
• Last Update Posted: September 16, 2019
• Sponsor: RemovAid AS
• Collaborator: Karolinska University Hospital
• Information provided by (Responsible Party): RemovAid AS

Tracking Information

• First Submitted Date: April 8, 2019
• First Posted Date: April 11, 2019
• Last Update Posted Date: September 16, 2019
• Estimated Study Start Date: December 11, 2019
• Estimated Primary Completion Date: March 30, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 10, 2019)

Successful removal of implant [ Time Frame: 15 minutes ]

The percentage of fixated implants that are successfully removed by the device without the use of additional tools

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT03912649 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: April 10, 2019)

• Frequency, severity, causality and outcome of adverse events (AEs) [ Time Frame: 1 week ]
  Both Anticipated and unanticipated AEs will be recorded, both immediately following the intervention and at follow-up
• Pain during procedure: Visual Analogue Scale [ Time Frame: 15 minutes ]
  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.
• Success of fixation of implant [ Time Frame: 5 minutes ]
  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.
• Duration of procedure [ Time Frame: 25 minutes ]
  Mean time from making incision until implant is removed, and first touching subject with the device until implant extracted
• Technical functionality of device determined by an operators questionnaire [ Time Frame: 5 minutes ]
  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
• Operators impression of the device [ Time Frame: 5 minutes ]
  The operator's global impression of the IMD will be assessed using a scale 1-5, where 5 is excellent and 1= poor
• Subject satisfaction: 5- point scale [ Time Frame: 5 minutes ]
  The subject's global assessment of satisfaction with the procedure will be assessed using a scale of 1-5, where 5 is excellent

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Investigation to Evaluate Performance and Safety of RemovAid ™ in Removal of Contraceptive 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

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.

Detailed Description

Similar to the REVALID and REVALID02 investigations, the REVALID03 investigation aims to recruit a total of 25 women with a palpable contraceptive implant due for removal, in order to obtain at least 20 successful fixations.

The implant retrieval device aims to standardize and simplify the implant removal procedure. There is no comparator in the investigation. Descriptive data will be recorded, all recruited subjects will be exposed to the investigational medical device (IMD) The primary endpoint is the percentage of fixated implants that are successfully removed without the use of additional tools.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Removal Contraceptive Implant

Intervention

Device: RemovAid

The RemovAid device is used for removal

Study Arms

Experimental: RemovAid arm

RemovAid arm -

All subjects have their implant removed by the RemovAid device

Intervention: Device: RemovAid

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.
• 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, 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: April 10, 2019): 25
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 30, 2020
• Estimated Primary Completion Date: March 30, 2020 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes

• Ages: 18 Years to 99 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Kristina Gemzell Danielsson, MD, PhD; +46 8 51772128; Kristina.Gemzell@ki.se

Contact: Marte Bratlie, MD; 93289105; marte@removaid.com

• Listed Location Countries: Sweden

Administrative Information

• NCT Number: NCT03912649
• Other Study ID Numbers: REVALID03
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: RemovAid AS
• Study Sponsor: RemovAid AS
• Collaborators: Karolinska University Hospital

Investigators

• Principal Investigator: Kristina Gemzell-Danielsson, MD, PhD; Karolinska Institutet

• PRS Account: RemovAid AS
• Verification Date: April 2019