Pilot Removal of Palpable Subdermal Contraceptive Rod Implants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-12

Study Completion Date

2018-09-04

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Removal of Contraceptive Implant

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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RemovAid arm

New IMD Subjects with contraceptive implants to be removed, are subjected to the novel device by personnel skilled in traditional removal.

Group Type EXPERIMENTAL

RemovAid device

Intervention Type DEVICE

The contraceptive implants of the subjects in this arm are removed by the new IMD.

Interventions

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RemovAid device

The contraceptive implants of the subjects in this arm are removed by the new IMD.

Intervention Type DEVICE

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)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No