BridgeMD
Tests treatment safety and results for IUD
Official title Assessing Pain and Effectiveness of Carevix Device for IUD Insertions
ClinicalTrials.gov ID: NCT07290517
What this study is testing
- What it's testing
- The goal of this clinical trial is to evaluate patient-reported pain, bleeding, and device efficiency along with provider satisfaction and ease of use between IUD insertions using a suction cervical stabilizer (new device, FDA approved, atraumatic) and single-tooth tenaculum (standard, traumatic). Our aims are to: assess and compare patient-reported pain during IUD insertion between the Carevix device and tenaculum.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- (to be assessed prior to procedure):
- Age 18 years or older
- Able to consent on their own
- Scheduled and will undergo an IUD insertion within 90 days of consent
- Planned use of cervical stabilization device for placement
You likely can't join if
- (to be assessed by provider at time of procedure):
- Vaginal bleeding of unknown origin
- Cervix less than 26 mm in diameter
- Nabothian cyst on anterior lip of cervix
- Cervical myomas
- Cervical abnormalities/shape
See the full eligibility criteria
- (to be assessed prior to procedure):
- Age 18 years or older
- Able to consent on their own
- Scheduled and will undergo an IUD insertion within 90 days of consent
- Planned use of cervical stabilization device for placement
- Procedure being performed by a trained provider
- Provider is willing to use Carevix™ for scheduled procedure
- (to be assessed by provider at time of procedure):
- Vaginal bleeding of unknown origin
- Cervix less than 26 mm in diameter
- Nabothian cyst on anterior lip of cervix
- Cervical myomas
- Cervical abnormalities/shape
- Pregnant
- Participants who are not fluent in and/or do not fully understand, read, write, or speak the English language
- Other inability to provide informed consent to participate
- Initial attempt to place the IUD without any cervical stabilization
The study team makes the final eligibility decision.
Where it's taking place
- Indianapolis, Indiana, 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Indianapolis, Indiana, 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.