Investigation to Evaluate Performance and Safety of RemovAid ™ in Removal of Contraceptive Implants
NCT03912649 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2021-02-03
Summary
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.
Conditions
- Removal Contraceptive Implant
Interventions
- DEVICE
-
RemovAid
The RemovAid device is used for removal
Sponsors & Collaborators
-
Karolinska University Hospital
collaborator OTHER -
RemovAid AS
lead INDUSTRY
Principal Investigators
-
Kristina Gemzell-Danielsson, MD, PhD · Karolinska Institutet
Study Design
- Allocation
- NA
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-06-11
- Primary Completion
- 2020-11-18
- Completion
- 2020-11-18
Countries
- Sweden
Study Locations
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