ContraceptionNCT04919395
Preliminary Evaluation of a "Clip" Device for Contraceptive Implant Removal
A study testing Clip device for Nexplanon Removal in people with Contraception, run by University of Michigan at 1 site in United States.
Trial summary
This trial is being completed to understand how the study "Clip" device works when assisting clinicians with Nexplanon removals. The study device clips to the skin to hold the implant still and raise the tip of the implant during removal. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Contraception
- What is being tested?
- Clip device for Nexplanon Removal
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2021to 23 Jun 2021
- 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 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Currently using Nexplanon and requesting removal
- Qualifies for outpatient removal
- Ability to understand and sign informed consent
Who cannot join
- Pregnancy
- Any rashes or skin conditions around the insertion site
- Known allergy to lidocaine
- Known allergy to biocompatible plastics or stainless steel
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a "Clip" Device Added to the Current Standard Removal of Contraceptive Implant to Improve Stability of the Implant, Shorten Removal Time, and Increase the Ease of Removal
This trial is being completed to understand how the study "Clip" device works when assisting clinicians with Nexplanon removals. The study device clips to the skin to hold the implant still and raise the tip of the implant during removal. The study device may improve the process for removing under arm implants by decreasing procedure time and improving the ease and safety of the procedure.
The results from this study will help the researchers understand whether the study device has the potential to simplify the removal procedure and make this form of birth control safer for patients.
- Conditions
- Contraception
- Being tested
- Clip device for Nexplanon Removal, Standard of Care procedure
- Keywords
- Nexplanon removal, Medical device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clip device for Nexplanon RemovalDevice
The clip device will be used to assist in the removal procedure to remove the Nexplanon implant from the subject.
Standard of Care procedureProcedure or surgery
The participants Nexplanon will be removed per standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Clip device removal | Experimental | Not described Receives: Device: Clip device for Nexplanon Removal |
| Standard of Care removal | Active comparator | Not described Receives: Procedure: Standard of Care procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to remove the contraceptive implant device
The amount of time that it takes to remove the contraceptive implant will be noted for both groups.
Measured: During the intervention/procedure/surgery
Length of incision used for the removal of the single rod contraceptive implant device
This will be recorded for both groups.
Measured: During the intervention/procedure/surgery
Secondary outcomes (1)
Pain based on the Wong-Baker FACES Pain rating scale from the removal of single rod contraceptive
Participants will be asked to rate the pain they experienced during the procedure.
Subjects will choose the face that best illustrates the pain they experienced during the procedure. Each face corresponds to a value on a 0-10 scale, with a higher score corresponding to more pain.
Measured: During the intervention/procedure/surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start16 Jun 2021
- Primary completion16 Jun 2021
- Study completion23 Jun 2021
Why it stopped: On the single day that the study was open, it became clear that modifications to the clip would be required. Only late in 2023 did it become clear that any continuation of the project would require a new trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Information regarding the planned intervention study model was removed, as the trial did not meet its recruitment goals.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- VentureWell
- Responsible party
- Principal investigator, Carrie Bell, MD, University of Michigan
- Investigators
- Carrie Bell, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04919395
- Sponsor's protocol ID
- HUM00172715
- Status last verified
- Jan 2024
- First submitted
- 27 May 2021
- Last updated
- 22 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a "Clip" Device Added to the Current Standard Removal of Contraceptive Implant to Improve Stability of the Implant, Shorten Removal Time, and Increase the Ease of Removal
- ClinicalTrials.gov ID
- NCT04919395
- Acronym / sponsor ID
- HUM00172715
- Conditions
- Contraception
- Keywords
- Nexplanon removal, Medical device
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: On the single day that the study was open, it became clear that modifications to the clip would be required. Only late in 2023 did it become clear that any continuation of the project would require a new trial.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- VentureWell
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- 16 Jun 2021 (actual)
- Study completion
- 23 Jun 2021 (actual)
- First posted
- 9 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is being completed to understand how the study "Clip" device works when assisting clinicians with Nexplanon removals. The study device clips to the skin to hold the implant still and raise the tip of the implant during removal. The study device may improve the process for removing under arm implants by decreasing procedure time and improving the ease and safety of the procedure.
The results from this study will help the researchers understand whether the study device has the potential to simplify the removal procedure and make this form of birth control safer for patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Information regarding the planned intervention study model was removed, as the trial did not meet its recruitment goals.
| Arm | Type | Receives |
|---|---|---|
| Clip device removal | Experimental | Device: Clip device for Nexplanon Removal |
| Standard of Care removal | Active comparator | Procedure: Standard of Care procedure |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Currently using Nexplanon and requesting removal
- Qualifies for outpatient removal
- Ability to understand and sign informed consent
Key exclusion criteria (4 listed)
- Pregnancy
- Any rashes or skin conditions around the insertion site
- Known allergy to lidocaine
- Known allergy to biocompatible plastics or stainless steel
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clip device for Nexplanon RemovalThe clip device will be used to assist in the removal procedure to remove the Nexplanon implant from the subject. | Device | Clip device removal |
| Standard of Care procedureThe participants Nexplanon will be removed per standard of care. | Procedure or surgery | Standard of Care removal |
Primary outcome
Time to remove the contraceptive implant device
Time frame: During the intervention/procedure/surgery
The amount of time that it takes to remove the contraceptive implant will be noted for both groups.
Length of incision used for the removal of the single rod contraceptive implant device
Time frame: During the intervention/procedure/surgery
This will be recorded for both groups.
1 secondary outcome
Pain based on the Wong-Baker FACES Pain rating scale from the removal of single rod contraceptive
Time frame: During the intervention/procedure/surgery
Results and safety
The study was stopped early (reason given: On the single day that the study was open, it became clear that modifications to the clip would be required. Only late in 2023 did it become clear that any continuation of the project would require a new trial.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carrie Bell, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clip device for Nexplanon Removal in people with Contraception, run by University of Michigan at 1 site in United States.
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 3 inclusion and 4 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 22 Jan 2024. 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 United States. 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: On the single day that the study was open, it became clear that modifications to the clip would be required. Only late in 2023 did it become clear that any continuation of the project would require a new trial.). 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?
Time to remove the contraceptive implant device (time frame: During the intervention/procedure/surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2024.