Removal of Palpable Subdermal Contraceptive Rod Implants.

Study Overview
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Brief Summary
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There are no implant removal devices on the market by any manufacturer. New features are described in comparison with the existing removal technique. Overall, the RemovAid™ combines the features of fixation, incision and extraction. This combination of functions has not previously been combined in a single device. The investigators wish to perform this pilot clinical investigation with the aim to demonstrate that the Investigational Medical Device (IMD), RemovAid ™, may safely and effectively facilitate implant removal. Other aims are to show that the IMD have the potential to reduce procedure length variability, reduce procedural complexity and reduce the need for additional procedural equipment related to CI removal procedures, without causing any harm to the subject.

Detailed Description
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Contraceptive Implants (CIs) were introduced to the commercial market in the early 1980s. They are advocated as a safe and effective method of contraception, and are included on the WHO's Essential Medicines list. CI manufacturers have focused intense efforts on making insertion of CIs easier, but have largely left CI removals untouched and at the mercy of the various service providers. Different introducers and trocars are available for use with the different CI systems available internationally, and a second generation, single-use trocar is supplied with the Nexplanon® implant system available in Sweden. This second generation trocar has reduced the number of misplaced or deeply inserted CIs, and underlines the benefits of standardizing minor surgical procedures through the use of dedicated medical devices. The CI removal procedure recommendations have remained essentially unchanged for 40 years, relying on scalpels, forceps and general surgical skills from the service provider. Currently, no standardized technique for removal of CIs exists, and no dedicated CI removal device is found on the commercial market. Removal of palpable subdermal implants is generally a simple, minor surgical office procedure. However, the procedure for implant removal requires more training and skill than the procedure for insertion. There is a risk of slippage of the scalpel blade or a sudden movement by the client causing inadvertent deeper penetration, in which case any underlying structure could be affected. Mean removal times, from time of incision until removal of the rod, are consistently reported as less than four minutes, however with ranges from 0.2 - 60 minutes. Available research shows that the procedure length of the current CI removal procedure is highly variable and reliant on individual operator skills.

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 of Contraceptive Implant

Intervention / Treatment
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* Device: New IMD


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/ Neplanon 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 Brouchure 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

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: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New IMD<br>Subjects with contraceptive implants to be removed, are subjected to the novel device by personnel skilled in traditional removal. | Device: New IMD<br>* The contraceptive implants of the subjects in this arm are removed by the new IMD.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful removal of implant | Percentage of fixated implants that were successfully removed without the use of additional tools. | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency, severity, causality and outcome of adverse events (AEs) | Frequency and severity of sharps injury, nerve damage, blood vessel damage, tissue damage, wound infection and cytotoxicity during and after the use of the device. Performed by investigation of site at the time of operation and one week later. | 1 week | 
| Pain during procedure | Mean pain score (maximum pain intensity during the procedure) indicated by the subject on a Visual Analogue Scale (VAS) 0-100 mm ruler, assuming that anaesthesia has been properly administered. | 5 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. | 5 minutes | 
| Duration of procedure | Mean time from making incision until implant is removed. first handling the device until closing the wound. | 25 minutes | 
| Technical functionality of device determined by an operators questionnaire. | Fulfilment of pre-defined technical requirements, as documented on an operator functionality questionnaire. | 5 minutes | 
| Operators impression of the device | The operator's global impression of the IMD will be assessed using a 5-point scale. | 5 minutes | 
| Subject satisfaction | The subject's global assessment of satisfaction with the procedure will be assessed using a 5- point scale. | 5 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contraceptive implant