Investigation to Evaluate Performance and Safety of RemovAid ™ in Removal of Contraceptive Implants (REVALID03)
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|ClinicalTrials.gov Identifier: NCT03912649|
Recruitment Status : Not yet recruiting
First Posted : April 11, 2019
Last Update Posted : September 16, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Removal Contraceptive Implant||Device: RemovAid||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|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|
|Estimated Study Start Date :||December 11, 2019|
|Estimated Primary Completion Date :||March 30, 2020|
|Estimated Study Completion Date :||April 30, 2020|
Experimental: RemovAid arm
RemovAid arm -
All subjects have their implant removed by the RemovAid device
The RemovAid device is used for removal
- Successful removal of implant [ Time Frame: 15 minutes ]The percentage of fixated implants that are successfully removed by the device without the use of additional tools
- Frequency, severity, causality and outcome of adverse events (AEs) [ Time Frame: 1 week ]Both Anticipated and unanticipated AEs will be recorded, both immediately following the intervention and at follow-up
- Pain during procedure: Visual Analogue Scale [ Time Frame: 15 minutes ]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.
- Success of fixation of implant [ Time Frame: 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. 80% or more is considered success.
- Duration of procedure [ Time Frame: 25 minutes ]Mean time from making incision until implant is removed, and first touching subject with the device until implant extracted
- Technical functionality of device determined by an operators questionnaire [ Time Frame: 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
- Operators impression of the device [ Time Frame: 5 minutes ]The operator's global impression of the IMD will be assessed using a scale 1-5, where 5 is excellent and 1= poor
- Subject satisfaction: 5- point scale [ Time Frame: 5 minutes ]The subject's global assessment of satisfaction with the procedure will be assessed using a scale of 1-5, where 5 is excellent
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03912649
|Contact: Kristina Gemzell Danielsson, MD, PhD||+46 8 51772128||Kristina.Gemzell@ki.se|
|Contact: Marte Bratlie, MDemail@example.com|
|Karolinska University Hospital|
|Stockholm, Sweden, 17176|
|Principal Investigator:||Kristina Gemzell-Danielsson, MD, PhD||Karolinska Institutet|