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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

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.


Condition or disease Intervention/treatment Phase
Removal Contraceptive Implant Device: RemovAid Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Estimated Study Start Date : December 11, 2019
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : April 30, 2020

Arm Intervention/treatment
Experimental: RemovAid arm

RemovAid arm -

All subjects have their implant removed by the RemovAid device

Device: RemovAid
The RemovAid device is used for removal




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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

  5. 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

  6. 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

  7. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03912649


Contacts
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Contact: Kristina Gemzell Danielsson, MD, PhD +46 8 51772128 Kristina.Gemzell@ki.se
Contact: Marte Bratlie, MD 93289105 marte@removaid.com

Locations
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Sweden
Karolinska University Hospital
Stockholm, Sweden, 17176
Sponsors and Collaborators
RemovAid AS
Karolinska University Hospital
Investigators
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Principal Investigator: Kristina Gemzell-Danielsson, MD, PhD Karolinska Institutet

Publications:

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Responsible Party: RemovAid AS
ClinicalTrials.gov Identifier: NCT03912649     History of Changes
Other Study ID Numbers: REVALID03
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs