BridgeMD
New treatment option for IUD
Official title TENS Unit for Analgesia During IUD Insertion
ClinicalTrials.gov ID: NCT06240260
What this study is testing
- What it's testing
- Subjects will be screened over the phone or in Tufts GYN clinic for participation in the study. If eligible and interested in participating, written informed consent (and assent if applicable) will be obtained.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 50, women only. Healthy volunteers may be eligible.
You may be able to join if
- Persons with a uterus desiring insertion of intrauterine device
- Able to provide informed consent/assent
- Age 12-50 years old
- Minors 12 years of age and older will be included in the study if postmenarchal
You likely can't join if
- Unable to provide informed consent/assent
- Prior cervical procedure (ie loop electrosurgical excision procedure, LEEP)
- Concurrent cervical or intrauterine procedure (ie colposcopy or dilation and curettage)
- Cutaneous damage at the TENS electrode sites
- Chronic or pre-procedure use of opioids
- Chronic pain diagnosis
See the full eligibility criteria
- Persons with a uterus desiring insertion of intrauterine device
- Able to provide informed consent/assent
- Age 12-50 years old
- Minors 12 years of age and older will be included in the study if postmenarchal
- Unable to provide informed consent/assent
- Prior cervical procedure (ie loop electrosurgical excision procedure, LEEP)
- Concurrent cervical or intrauterine procedure (ie colposcopy or dilation and curettage)
- Cutaneous damage at the TENS electrode sites
- Chronic or pre-procedure use of opioids
- Chronic pain diagnosis
- Prior IUD insertion
- Any contraindication to intrauterine device (IUD):
- Pregnancy
- Uterine anomaly that distorts the uterine cavity
- Acute pelvic inflammatory disease (PID)
- Postpartum endometritis or infected abortion in the past 3 months
- Unexplained abnormal uterine bleeding
- Wilson's disease or copper allergy (contraindication to copper IUD only)
- Breast cancer (contraindication to levonorgestrel IUD only
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 12 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.