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

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

Tracking Information
First Submitted Date  ICMJE April 8, 2019
First Posted Date  ICMJE April 11, 2019
Last Update Posted Date September 16, 2019
Estimated Study Start Date  ICMJE December 11, 2019
Estimated Primary Completion Date March 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History Complete list of historical versions of study NCT03912649 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigation to Evaluate Performance and Safety of RemovAid ™ in Removal of Contraceptive Implants
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Removal Contraceptive Implant
Intervention  ICMJE Device: RemovAid
The RemovAid device is used for removal
Study Arms  ICMJE Experimental: RemovAid arm

RemovAid arm -

All subjects have their implant removed by the RemovAid device

Intervention: Device: RemovAid
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 10, 2019)
25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2020
Estimated Primary Completion Date March 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kristina Gemzell Danielsson, MD, PhD +46 8 51772128 Kristina.Gemzell@ki.se
Contact: Marte Bratlie, MD 93289105 marte@removaid.com
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03912649
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Responsible Party RemovAid AS
Study Sponsor  ICMJE RemovAid AS
Collaborators  ICMJE Karolinska University Hospital
Investigators  ICMJE
Principal Investigator: Kristina Gemzell-Danielsson, MD, PhD Karolinska Institutet
PRS Account RemovAid AS
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP