Investigation to Evaluate Performance and Safety of Remov... | NCT03912649

Studies
Investigation to Evaluate Performance and Safety of RemovAid ™ in Removal of Contraceptive Implants

NCT03912649

Sponsor

RemovAid AS

Status

Terminated

Last Update Posted

Feb 3, 2021Actual

Enrollment

15Actual

Phase

Not Applicable

Conditions

Removal Contraceptive Implant

Interventions

RemovAid

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Although the defined success rate needed for continuation of the investigation was met, due to the overall low success rate; it was considered, particularly considering the ongoing pandemic, to discontinue the investigation prematurely.

Expanded Access Info

Start Date

Jun 11, 2019Actual

Primary Completion Date

Nov 18, 2020Actual

Completion Date

Nov 18, 2020Actual

First Submitted Date

Apr 8, 2019

First Submission Date that Met QC Criteria

Apr 10, 2019

First Posted Date

Apr 11, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 29, 2021

Last Update Posted Date

Feb 3, 2021Actual

Name	Class
Karolinska University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RemovAid arm	Experimental	RemovAid arm - All subjects have their implant removed by the RemovAid device	Device: RemovAid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RemovAid	Device	The RemovAid device is used for removal	RemovAid arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Successful removal of implant	The percentage of fixated implants that are successfully removed by the device without the use of additional tools	15 minutes

Secondary Outcomes

Measure	Description	Time Frame
Frequency, severity, causality and outcome of adverse events (AEs)	Both Anticipated and unanticipated AEs will be recorded, both immediately following the intervention and at follow-up	1 week
Pain during procedure: Visual Analogue Scale

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kristina Gemzell-Danielsson, MD, PhD	Karolinska Institutet	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Karolinska University Hospital		Stockholm		17176	Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22996129	Background	Committee on Adolescent Health Care Long-Acting Reversible Contraception Working Group, The American College of Obstetricians and Gynecologists. Committee opinion no. 539: adolescents and long-acting reversible contraception: implants and intrauterine devices. Obstet Gynecol. 2012 Oct;120(4):983-8. doi: 10.1097/AOG.0b013e3182723b7d.
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