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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Removal Contraceptive Implant

Intervention / Treatment
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* Device: RemovAid


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RemovAid arm<br>RemovAid arm - All subjects have their implant removed by the RemovAid device | Device: RemovAid<br>* The RemovAid device is used for removal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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