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Removal of Contraceptive ImplantREVALID02NCT03356119

Pilot Removal of Palpable Subdermal Contraceptive Rod Implants

A study testing RemovAid device in people with Removal of 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
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Trial summary

There are no implant removal devices on the market by any manufacturer. Overall, the RemovAid™ combines the features of fixation, incision and extraction. This combination of functions has not previously been combined in a single device. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Removal of Contraceptive Implant
What is being tested?
RemovAid device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteSweden
Study dates
12 Dec 2017to 4 Sep 2018
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 years and older
  • 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.

There are no implant removal devices on the market by any manufacturer. Overall, the RemovAid™ combines the features of fixation, incision and extraction. This combination of functions has not previously been combined in a single device.

The investigators wish to perform this pilot clinical investigation with the aim to demonstrate that the Investigational Medical Device (IMD), RemovAid ™, may safely and effectively facilitate implant removal. Other aims are to show that the IMD have the potential to reduce procedure length variability, reduce procedural complexity and reduce the need for additional procedural equipment related to CI removal procedures, without causing any harm to the subject.

Read the detailed description

Detailed Description:

Contraceptive Implants (CIs) were introduced to the commercial market in the early 1980s. They are advocated as a safe and effective method of contraception, and are included on the WHO's Essential Medicines list.

CI manufacturers have focused intense efforts on making insertion of CIs easier, but have largely left CI removals untouched and at the mercy of the various service providers. Different introducers and trocars are available for use with the different CI systems available internationally, and a second generation, single-use trocar is supplied with the Nexplanon® implant system available in Sweden. This second generation trocar has reduced the number of misplaced or deeply inserted CIs, and underlines the benefits of standardizing minor surgical procedures through the use of dedicated medical devices.

The CI removal procedure recommendations have remained essentially unchanged for 40 years, relying on scalpels, forceps and general surgical skills from the service provider. Currently, no standardized technique for removal of CIs exists, and no dedicated CI removal device is found on the commercial market.

Removal of palpable subdermal implants is generally a simple, minor surgical office procedure. However, the procedure for implant removal requires more training and skill than the procedure for insertion. There is a risk of slippage of the scalpel blade or a sudden movement by the client causing inadvertent deeper penetration, in which case any underlying structure could be affected.

Mean removal times, from time of incision until removal of the rod, are consistently reported as less than four minutes, however with ranges from 0.2 - 60 minutes.

Available research shows that the procedure length of the current CI removal procedure is highly variable and reliant on individual operator skills.

Being tested
RemovAid device
Keywords
Contraceptive Implant

What participants receive

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

  • RemovAid deviceDevice

    The contraceptive implants of the subjects in this arm are removed by the new IMD.

Study groups in NCT03356119
Study groupRoleWhat they receive
RemovAid armExperimentalNew IMD Subjects with contraceptive implants to be removed, are subjected to the novel device by personnel skilled in traditional removal.
Receives: Device: RemovAid device

What is being measured

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

  1. Successful removal of implant .

    Percentage of fixated implants that were successfully removed 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

    Mean pain score (maximum pain intensity during the procedure) indicated by the subject on a Visual Analogue Scale (VAS) 0-100 mm ruler, assuming that anaesthesia has been properly administered.

    Measured: 5 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

    Measured: 5 minutes

  4. Duration of procedure

    Mean time from making incision until implant is removed. first handling the device until closing the wound.

    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 5-point scale, where 5 is excellent

    Measured: 5 minutes

  7. Subject satisfaction

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

    Measured: Time Frame: 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 posted29 Nov 2017
  2. Study start12 Dec 2017
  3. Primary completion1 May 2018
  4. Study completion4 Sep 2018

Why it stopped: Inufficient IMD supply due to manufacturing issue

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
Health services research
Allocation
Not applicable
Intervention model
Single group
Model description
All recruited subjects will be assigned to implant removal using the RemovAid IMD. There is no formal comparator in this study. The investigators are investigating design functionality and safety.
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03356119
Sponsor's protocol ID
REVALID02
Acronym
REVALID02
Status last verified
Oct 2018
First submitted
20 Nov 2017
Last updated
18 Oct 2018
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 device in people with Removal of 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 18 Oct 2018. 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: Inufficient IMD supply due to manufacturing issue). 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 NCT03356119, 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 18 Oct 2018.

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