Investigation to Evaluate Performance and Safety of RemovAid ™ in Removal of Contraceptive Implants (REVALID03)

RemovAid

Status

Terminated

Conditions

Removal Contraceptive Implant

Treatments

Device: RemovAid

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03912649

REVALID03

Details and patient eligibility

About

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.

Full description

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.

Enrollment

15 patients

Sex

Female

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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)