AzTrials
AzTrials

Removal Contraceptive ImplantREVALID03NCT03912649

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

A study testing RemovAid in people with Removal Contraceptive Implant, run by RemovAid AS at 1 site in Sweden.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 99 years, women only
Conditions the study is for
Removal Contraceptive Implant
What is being tested?
RemovAid
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteSweden
Study dates
11 Jun 2019to 18 Nov 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Karolinska University Hospital

    Stockholm, 17176

Other trials in Sweden

About this study

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

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.

Read the 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.

Being tested
RemovAid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RemovAidDevice

    The RemovAid device is used for removal

Study groups in NCT03912649
Study groupRoleWhat they receive
RemovAid armExperimentalRemovAid arm - All subjects have their implant removed by the RemovAid device
Receives: Device: RemovAid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Successful removal of implant

    The percentage of fixated implants that are successfully removed by the device without the use of additional tools

    Measured: 15 minutes

Secondary outcomes (7)

  1. 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

    Measured: 1 week

  2. Pain during procedure: Visual Analogue Scale

    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.

    Measured: 15 minutes

  3. Success of fixation of implant

    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.

    Measured: 5 minutes

  4. Duration of procedure

    Mean time from making incision until implant is removed, and first touching subject with the device until implant extracted

    Measured: 25 minutes

  5. Technical functionality of device determined by an operators questionnaire

    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

    Measured: 5 minutes

  6. Operators impression of the device

    The operator's global impression of the IMD will be assessed using a scale 1-5, where 5 is excellent and 1= poor

    Measured: 5 minutes

  7. Subject satisfaction: 5- point scale

    The subject's global assessment of satisfaction with the procedure will be assessed using a scale of 1-5, where 5 is excellent

    Measured: 5 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2019
  2. Study start11 Jun 2019
  3. Primary completion18 Nov 2020
  4. Study completion18 Nov 2020

Why it 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.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03912649
Sponsor's protocol ID
REVALID03
Acronym
REVALID03
Status last verified
Jan 2021
First submitted
8 Apr 2019
Last updated
3 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22996129

  • Mansour D, Mommers E, Teede H, Sollie-Eriksen B, Graesslin O, Ahrendt HJ, Gemzell-Danielsson K. Clinician satisfaction and insertion characteristics of a new applicator to insert radiopaque Implanon: an open-label, noncontrolled, multicenter trial. Contraception. 2010 Sep;82(3):243-9. doi: 10.1016/j.contraception.2010.04.007. Epub 2010 May 18.

    PubMed 20705152

  • Mommers E, Blum GF, Gent TG, Peters KP, Sordal TS, Marintcheva-Petrova M. Nexplanon, a radiopaque etonogestrel implant in combination with a next-generation applicator: 3-year results of a noncomparative multicenter trial. Am J Obstet Gynecol. 2012 Nov;207(5):388.e1-6. doi: 10.1016/j.ajog.2012.08.002. Epub 2012 Aug 10.

    PubMed 22939402

  • Webb AM. Why go to Tiger Country? A report of two cases of Implanon removal. J Fam Plann Reprod Health Care. 2006 Jul;32(3):193-4. doi: 10.1783/147118906777888233. No abstract available.

    PubMed 16857083

  • Levine JP, Sinofsky FE, Christ MF; Implanon US Study Group. Assessment of Implanon insertion and removal. Contraception. 2008 Nov;78(5):409-17. doi: 10.1016/j.contraception.2008.06.016. Epub 2008 Sep 18.

    PubMed 18929739

  • Funk S, Miller MM, Mishell DR Jr, Archer DF, Poindexter A, Schmidt J, Zampaglione E; Implanon US Study Group. Safety and efficacy of Implanon, a single-rod implantable contraceptive containing etonogestrel. Contraception. 2005 May;71(5):319-26. doi: 10.1016/j.contraception.2004.11.007.

    PubMed 15854630

Questions about this trial

What is this clinical trial studying?

A study testing RemovAid in people with Removal Contraceptive Implant, run by RemovAid AS at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: 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.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Successful removal of implant (time frame: 15 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03912649, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in