Women With an ENG Contraceptive ImplantENGNCT02986204
Identification and Removal of the Non Palpable Etonogestrel Contraceptive Implant
A study testing removal of ENG implant and continuation of ING implant in people with Women With an ENG Contraceptive Implant, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This study will investigate in-office ultrasound localization vs localization in radiology for identification and removal of non palpable etonogestrel (ENG) contraceptive implants and aims to help establish best practices in this domain. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Women With an ENG Contraceptive Implant
- What is being tested?
- removal of ENG implant and continuation of ING implant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to May 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women age 18 - 50 years old
- English or Spanish speaking
- ENG implant in place
- Removal group
- o Women with non palpable ENG implant desiring ENG implant removal
- Continuation group o Women with palpable or non-palpable ENG implant desiring continuation
Who cannot join
- Known or suspected pregnancy
- Does not meet inclusion criteria
- Known ENG implant location outside of arm
- Current anticoagulation use (removal group only)
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Dept. OB/GYN, Women's Health CRU, 10833 Le Conte Ave, CHS 22-265
Los Angeles, California, 90095
About this study
This study will investigate in-office ultrasound localization vs localization in radiology for identification and removal of non palpable etonogestrel (ENG) contraceptive implants and aims to help establish best practices in this domain. Investigators will also create an ultrasound image gallery of palpable and non palpable as well as instructional video for non palpable ENG implant removal.
Read the detailed description
This is a descriptive study to establish best practices for ENG implant localization and non-palpable ENG implant removal.
Women presenting to UCLA Obstetrics and Gynecology service for ENG non-palpable and palpable implant removal or with ENG implant in place but desiring continuation will be enrolled. Investigators aim to enroll 20 women in each group. Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria will be entered into the study.
Study duration for each participant is one visit for continuation group and two weeks for group desiring implant removal. Total study duration is expected to be 18 months.
- For women desiring implant removal: document ENG implant using in-office imaging of ENG implant in the FP clinic with standard ob/gyn office ultrasound (abdominal 15 MHz linear probe with color doppler) and the same, using high frequency vascular probe (20+ MHz) in the radiology department.
- Create an image gallery of office and radiology department obtained images of ENG implant localization. This will include:
- Ultrasound images obtained in women with palpable or non-palpable ENG implants in place at various time intervals after insertion who desire ENG implant continuation (office imaging only).
- Ultrasound images obtained in women seeking removal of non-palpable ENG implants, primarily referred patients who have either failed outside implant removal or have a non-palpable implant on presentation for removal.
- Document and describe all cases of non palpable ENG implant removal with standard, in-office US versus radiology ultrasound equipment. Investigators will collect radiographic images, clinical findings, instruments used, patient characteristics (BMI, weight gain, time since of insertion), success of procedure, duration of procedure, number of attempts, final location of implant, and need for referral to general or vascular surgeon.
- Conditions
- Women With an ENG Contraceptive Implant
- Being tested
- removal of ENG implant, continuation of ING implant
- Keywords
- implant removal, Nexplanon, Implanon, contraception, ENG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
removal of ENG implantProcedure or surgery
the researcher(s) will ask you to: Visit 1 - SCREENING VISIT
- questions about your medical/contraception history
- Review medical record
- physical examination
- urine sample for pregnancy test
Visit 2a - Radiology
- Have an ultrasound of your arm
- The radiologist will mark your arm at the location of the implant.
Visit 2b
- ultrasound of your arm to locate the implant. This is done by feeling the area.
- Have your ENG implant removed through a numbed small cut. The researcher will apply a pressure bandage to the site(s). This will reduce bleeding/decrease swelling.
- Have the removal procedure video recorded.
Visit 3 - FOLLOW UP VISIT approximately 2 weeks after Visit 2:
- Provide a urine sample for pregnancy test
- Have the implant removal site examined
continuation of ING implantProcedure or surgery
the researcher(s) will ask you to:
- To answer questions about your medical and contraception history
- Review your medical record
- Have a physical examination by the researcher
- Provide a urine sample for pregnancy test
- Have an ultrasound of your arm
| Study group | Role | What they receive |
|---|---|---|
| removal of ENG implant group | Other | 20 women who have an ENG implant that is difficult to feel on exam and would like to have it removed. Receives: Procedure: removal of ENG implant |
| continuation of ENG implant | Other | 20 women who have are continuing to use their ENG implant. Receives: Procedure: continuation of ING implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Creation of image gallery
Creating an image gallery in order to locate ENG implant using ultrasound and radiological images
Measured: 18 months
Secondary outcomes (1)
Creation of an instructional video and reference guide for ENG implant removal.
If ultrasound/radiological images are successful at locating ENG implant, this data could lead to the creation of a reference guide for other providers.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionMay 2020
- Study completionMay 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Women With an ENG Contraceptive ImplantStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Chen, MD, University of California, Los Angeles
- Investigators
- UCLA Dept. OB/GYN Div. of Family Planning, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02986204
- Sponsor's protocol ID
- version 1.0 07/25/16
- Acronym
- ENG
- Status last verified
- Apr 2021
- First submitted
- 2 Dec 2016
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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 22939402Pillai M, Gazet AC, Griffiths M. Continuing need for and provision of a service for non-standard implant removal. J Fam Plann Reprod Health Care. 2014 Apr;40(2):126-32. doi: 10.1136/jfprhc-2013-100619. Epub 2013 Sep 30.
PubMed 24081828Guiahi M, Tocce K, Teal S, Green T, Rochon P. Removal of a Nexplanon implant located in the biceps muscle using a combination of ultrasound and fluoroscopy guidance. Contraception. 2014 Dec;90(6):606-8. doi: 10.1016/j.contraception.2014.06.030. Epub 2014 Jun 27.
PubMed 25081861Chen MJ, Creinin MD. Removal of a Nonpalpable Etonogestrel Implant With Preprocedure Ultrasonography and Modified Vasectomy Clamp. Obstet Gynecol. 2015 Nov;126(5):935-938. doi: 10.1097/AOG.0000000000001082.
PubMed 26444124Singh M, Mansour D, Richardson D. Location and removal of non-palpable Implanon implants with the aid of ultrasound guidance. J Fam Plann Reprod Health Care. 2006 Jul;32(3):153-6. doi: 10.1783/147118906777888549.
PubMed 16857066
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Removal of the Non Palpable Etonogestrel Contraceptive Implant
- ClinicalTrials.gov ID
- NCT02986204
- Acronym / sponsor ID
- ENG / version 1.0 07/25/16
- Conditions
- Women With an ENG Contraceptive Implant
- Keywords
- implant removal, Nexplanon, Implanon, contraception, ENG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- May 2020 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 8 Dec 2016 (estimated)
- 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 study will investigate in-office ultrasound localization vs localization in radiology for identification and removal of non palpable etonogestrel (ENG) contraceptive implants and aims to help establish best practices in this domain. Investigators will also create an ultrasound image gallery of palpable and non palpable as well as instructional video for non palpable ENG implant removal.
Detailed description
This is a descriptive study to establish best practices for ENG implant localization and non-palpable ENG implant removal.
Women presenting to UCLA Obstetrics and Gynecology service for ENG non-palpable and palpable implant removal or with ENG implant in place but desiring continuation will be enrolled. Investigators aim to enroll 20 women in each group. Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria will be entered into the study.
Study duration for each participant is one visit for continuation group and two weeks for group desiring implant removal. Total study duration is expected to be 18 months.
- For women desiring implant removal: document ENG implant using in-office imaging of ENG implant in the FP clinic with standard ob/gyn office ultrasound (abdominal 15 MHz linear probe with color doppler) and the same, using high frequency vascular probe (20+ MHz) in the radiology department.
- Create an image gallery of office and radiology department obtained images of ENG implant localization. This will include:
- Ultrasound images obtained in women with palpable or non-palpable ENG implants in place at various time intervals after insertion who desire ENG implant continuation (office imaging only).
- Ultrasound images obtained in women seeking removal of non-palpable ENG implants, primarily referred patients who have either failed outside implant removal or have a non-palpable implant on presentation for removal.
- Document and describe all cases of non palpable ENG implant removal with standard, in-office US versus radiology ultrasound equipment. Investigators will collect radiographic images, clinical findings, instruments used, patient characteristics (BMI, weight gain, time since of insertion), success of procedure, duration of procedure, number of attempts, final location of implant, and need for referral to general or vascular surgeon.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| removal of ENG implant group | Other | Procedure: removal of ENG implant20 women who have an ENG implant that is difficult to feel on exam and would like to have it removed. |
| continuation of ENG implant | Other | Procedure: continuation of ING implant20 women who have are continuing to use their ENG implant. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women age 18 - 50 years old
- English or Spanish speaking
- ENG implant in place
- Removal group
- o Women with non palpable ENG implant desiring ENG implant removal
Key exclusion criteria (4 listed)
- Known or suspected pregnancy
- Does not meet inclusion criteria
- Known ENG implant location outside of arm
- Current anticoagulation use (removal group only)
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 |
|---|---|---|
| removal of ENG implantthe researcher(s) will ask you to: Visit 1 - SCREENING VISIT * questions about your medical/contraception history * Review medical record * physical examination * urine sample for pregnancy test Visit 2a - Radiology * Have an ultrasound of your arm * The radiologist will mark your arm at the location of the implant. Visit 2b * ultrasound of your arm to locate the implant. This is done by feeling the area. * Have your ENG implant removed through a numbed small cut. The researcher will apply a pressure bandage to the site(s). This will reduce bleeding/decrease swelling. * Have the removal procedure video recorded. Visit 3 - FOLLOW UP VISIT approximately 2 weeks after Visit 2: * Provide a urine sample for pregnancy test * Have the implant removal site examined | Procedure or surgery | removal of ENG implant group |
| continuation of ING implantthe researcher(s) will ask you to: * To answer questions about your medical and contraception history * Review your medical record * Have a physical examination by the researcher * Provide a urine sample for pregnancy test * Have an ultrasound of your arm | Procedure or surgery | continuation of ENG implant |
Primary outcome
Creation of image gallery
Time frame: 18 months
Creating an image gallery in order to locate ENG implant using ultrasound and radiological images
1 secondary outcome
Creation of an instructional video and reference guide for ENG implant removal.
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Background: PubMed 22939402Mommers 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.
- Background: PubMed 24081828Pillai M, Gazet AC, Griffiths M. Continuing need for and provision of a service for non-standard implant removal. J Fam Plann Reprod Health Care. 2014 Apr;40(2):126-32. doi: 10.1136/jfprhc-2013-100619. Epub 2013 Sep 30.
- Background: PubMed 25081861Guiahi M, Tocce K, Teal S, Green T, Rochon P. Removal of a Nexplanon implant located in the biceps muscle using a combination of ultrasound and fluoroscopy guidance. Contraception. 2014 Dec;90(6):606-8. doi: 10.1016/j.contraception.2014.06.030. Epub 2014 Jun 27.
- Background: PubMed 26444124Chen MJ, Creinin MD. Removal of a Nonpalpable Etonogestrel Implant With Preprocedure Ultrasonography and Modified Vasectomy Clamp. Obstet Gynecol. 2015 Nov;126(5):935-938. doi: 10.1097/AOG.0000000000001082.
- Background: PubMed 16857066Singh M, Mansour D, Richardson D. Location and removal of non-palpable Implanon implants with the aid of ultrasound guidance. J Fam Plann Reprod Health Care. 2006 Jul;32(3):153-6. doi: 10.1783/147118906777888549.
- Individual participant dataSharing planned: No
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.
UCLA Dept. OB/GYN Div. of Family Planning principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing removal of ENG implant and continuation of ING implant in people with Women With an ENG Contraceptive Implant, run by University of California, Los Angeles 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 6 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: finished, as of the sponsor's last update on 30 Apr 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Creation of image gallery (time frame: 18 months). 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 NCT02986204, which also lists 5 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 30 Apr 2021.