Identification and Removal of the Non Palpable Etonogestrel Contraceptive Implant (ENG)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02986204|
Recruitment Status : Not yet recruiting
First Posted : December 8, 2016
Last Update Posted : December 12, 2016
|Condition or disease||Intervention/treatment||Phase|
|Women With an ENG Contraceptive Implant||Procedure: removal of ENG implant Procedure: continuation of ING implant||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Identification and Removal of the Non Palpable Etonogestrel Contraceptive Implant|
|Study Start Date :||January 2017|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||December 2018|
removal of ENG implant group
20 women who have an ENG implant that is difficult to feel on exam and would like to have it removed.
Procedure: removal of ENG implant
the researcher(s) will ask you to: Visit 1 - SCREENING VISIT
Visit 2a - Radiology
Visit 3 - FOLLOW UP VISIT approximately 2 weeks after Visit 2:
continuation of ENG implant
20 women who have are continuing to use their ENG implant.
Procedure: continuation of ING implant
the researcher(s) will ask you to:
- Creation of image gallery [ Time Frame: 18 months ]Creating an image gallery in order to locate ENG implant using ultrasound and radiological images
- Creation of an instructional video and reference guide for ENG implant removal. [ Time Frame: 18 months ]If ultrasound/radiological images are successful at locating ENG implant, this data could lead to the creation of a reference guide for other providers.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02986204
|Contact: UCLA Dept. OB/GYN Women's Health CRU||310 825 0580||UCLAOBGYNResearch@mednet.ucla.edu|
|United States, California|
|UCLA Dept. OB/GYN, Women's Health CRU, 10833 Le Conte Ave, CHS 22-265||Not yet recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Ross M. Divinagracia 310-825-0580 UCLAOBGYNResearch@mednet.ucla.edu|
|Contact: Sonali S Namiranian 310-794-9095|
|Principal Investigator:||UCLA Dept. OB/GYN Div. of Family Planning||University of California, Los Angeles|