Removal of Contraceptive Implant
Conditions
Keywords
Contraceptive Implant
Brief summary
There are no implant removal devices on the market by any manufacturer. 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
Detailed Description: 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.
Interventions
DEVICERemovAid device
The contraceptive implants of the subjects in this arm are removed by the new IMD.
Sponsors
Karolinska University Hospital
Bill and Melinda Gates Foundation
The Research Council of Norway
Amano Clinical Consulting AB
RemovAid AS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
All recruited subjects will be assigned to implant removal using the RemovAid IMD. There is no formal comparator in this study. The investigators are investigating design functionality and safety.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful removal of implant . | 15 minutes | Percentage of fixated implants that were successfully removed without the use of additional tools |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain during procedure | 5 minutes | 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. |
| Success of fixation of implant | 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 |
| Duration of procedure | 25 minutes | Mean time from making incision until implant is removed. first handling the device until closing the wound. |
| Frequency, severity, causality and outcome of adverse events (AEs) | 1 week | Both Anticipated and unanticipated AEs will be recorded, both immediately following the intervention and at follow-up. |
| Operators impression of the device | 5 minutes | The operator's global impression of the IMD will be assessed using a 5-point scale, where 5 is excellent |
| Subject satisfaction | Time Frame: 5 minutes | The subject's global assessment of satisfaction with the procedure will be assessed using a 5- point scale, where 5 is excellent |
| Technical functionality of device determined by an operators questionnaire | 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 |
Countries
Sweden
Outcome results
None listed