Removal of Contraceptive Implant Clinical Trial
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.
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:
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT02986971 -
Removal of Palpable Subdermal Contraceptive Rod Implants.
|
N/A |