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.
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
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
15
The RemovAid device is used for removal
Karolinska University Hospital
Stockholm, Sweden
Successful removal of implant
The percentage of fixated implants that are successfully removed by the device without the use of additional tools
Time frame: 15 minutes
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
Time frame: 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.
Time frame: 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.
Time frame: 5 minutes
Duration of procedure
Mean time from making incision until implant is removed, and first touching subject with the device until implant extracted
Time frame: 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
Time frame: 5 minutes
Operators impression of the device
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The operator's global impression of the IMD will be assessed using a scale 1-5, where 5 is excellent and 1= poor
Time frame: 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
Time frame: 5 minutes