IUDCARENCT07290517
Assessing Pain and Effectiveness of Carevix Device for IUD Insertions
A study testing Carevix and Tenaculum in people with IUD and Abnormal Uterine Bleeding, run by Indiana University at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- IUD, Abnormal Uterine Bleeding, Pain, Cervical
- What is being tested?
- Carevix and Tenaculum
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2026to Mar 2027
- Phase
- Interventional
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Exclusion Criteria (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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kylie L Williams, MA contact
United States1 site, 1 recruiting
- Recruiting
Indiana University Hospital
Indianapolis, Indiana, 46202
Alissa M Conklin, MD, 317-944-8231, alconkli@iu.edu
About this study
Official title: The Carevix Device: Assessing Pain and Effectiveness of a Suction-based Cervical Stabilizer for IUD Insertions in the Clinic Setting: a Randomized, Controlled Trial (CARE)
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.
- assess predictors of pain scores including between nulliparous and multiparous patients
- assess provider-reported ease of use and satisfaction
Read more
Participants (including providers) will:
- be randomized to receive one device to complete the IUD procedure
- complete a survey following the procedure
Read the detailed description
The primary objective is to assess and compare patient-reported pain during IUD insertion between the Carevix device and tenaculum. The hypothesis is that patient-reported pain scores comparing Carevix™ to tenaculum will be lower. The investigators will assess pain, and predictors for pain scores including nulliparous vs multiparous, when highest pain scores are reported, and expectation of pain for the procedure.
The secondary objective will be to assess Usability (provider assessment of ease of use, number of device placement attempts to secure sufficient traction on uterus), efficacy (ability to insert IUD with Carevix™ device alone without recourse to conventional tenaculum or other instruments), provider reported bleeding (cervical bleeding and ecchymosis), overall provider satisfaction, patient-reported pain scores at device placement prior to IUD insertion procedure and after completion of IUD insertion using Visual Analog Scale (VAS), overall patient satisfaction, and overall provider satisfaction. The investigators aim to expand the pilot trial data collection to assess cultural background, ethnicity and demographics while also assessing prior contraceptive choices, reasons for discontinuation of prior choices and reasons for current selection of IUD insertion and any anticipated barriers for removal.
- Conditions
- IUD, Abnormal Uterine Bleeding, Pain, Cervical
- Being tested
- Carevix, Tenaculum
- Keywords
- IUD insertion, Cervical Stabilization, Tenaculum, Pain
- Medical subject headings
- Metrorrhagia, Neck Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarevixDevice
Vacuum cervical stabilization device
TenaculumDevice
Standard of care cervical stabilization device
| Study group | Role | What they receive |
|---|---|---|
| Carevix | Experimental | Patients will receive the atraumatic, suction-based, cervical stabilizer (Carevix) for their IUD insertion. Receives: Device: Carevix |
| Tenaculum | Active comparator | Patients will receive the standard of care device (single tooth tenaculum) for their IUD insertion. Receives: Device: Tenaculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient pain score
Participants will be asked to rate their pain prior to, during, and after the IUD insertion procedure on a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable."
Measured: During Procedure (at Cervix Grasping, at Cervix Traction, and at IUD placement)
Difference in Pain Score
Participants will be asked to rate their pain prior to, during, and after the IUD insertion procedure on a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable." Pain scores will be compared among nulliparous and multiparous participants
Measured: Prior to procedure, during procedure (at cervix grasping, at cervix traction, at IUD placement), and 5 minutes after procedure completion
Highest Pain Score
Participants will be asked to rate their pain prior to, during, and after the IUD insertion procedure on a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable." The time at which the highest pain score was reported will be compared.
Measured: Prior to procedure, during procedure (at cervix grasping, at cervix traction, at IUD placement), and 5 minutes after procedure completion
Expectation of Pain
Participants will be asked to rate their expectation of pain on a scale of 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable."
Measured: Within 15 minutes after IUD procedure completion
Secondary outcomes (12)
Provider device satisfaction - Time to Use Device
Providers will be asked to provide their agreement that procedure time was not extended due to the device use on a 5 point Likert scale from "Strongly Disagree"-"Strongly Agree"
Measured: Immediately after IUD procedure
Provider device satisfaction - Impact on Patient Discomfort
Providers will be asked whether the device's use impacted patient discomfort on a 5 point Likert scale from "Strongly Disagree"-"Strongly Agree."
Measured: Immediately after IUD insertion procedure
Provider device satisfaction - Device Preference
Providers will be asked to rate their overall satisfaction with the device on a 5 point Likert scale from "Strongly Disagree"-"Strongly Agree"
Measured: Immediately after IUD insertion procedure
Provider device satisfaction - Procedure Visibility
Providers will be asked to rate visibility while using the device on a 5 point Likert scale from "Strongly Disagree"-"Strongly Agree"
Measured: Immediately after IUD insertion procedure
Provider device satisfaction - Pulling Strength
Providers will be asked to rate the device's pulling strength as adequate on a 5 point Likert scale from "Strongly Disagree"-"Strongly Agree"
Measured: Immediately after IUD insertion procedure
Provider device satisfaction (Ease of Use)
Providers using the Carevix device will be asked to rate ease of use on a 5 point Likert scale from "Strongly Disagree"-"Strongly Agree."
Measured: Immediately after IUD procedure
Number of Device Placement Attempts
Providers are asked to report the number of attempts required for device placement
Measured: Immediately after IUD insertion procedure
Need for Device Replacement
Providers who use the Carevix device will be asked if the procedure's successful completion required replacing the Carevix device with the cervical tenaculum
Measured: Immediately after IUD insertion procedure
Provider Reported Bleeding
The number of providers who had to manage or stop bleeding on cervical tissues will be compared.
Measured: Immediately after IUD insertion procedure
Time to Bleeding Cessation
The time (minutes) required for the providers to stop bleeding of cervical tissues will be compared.
Measured: Immediately after IUD procedure completion
Patient pain score
Participants will be asked to rate their pain prior to, during, and after the IUD insertion procedure on a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable."
Measured: Prior to Procedure and 5 minutes after procedure completion
Overall Patient Satisfaction
Participants will rate their satisfaction with the procedure on a 5 point Likert scale from 5 point Likert scale from "Strongly Disagree"-"Strongly Agree"
Measured: Immediately after IUD procedure completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start11 Mar 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IUDStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Aspivix SA
- Responsible party
- Principal investigator, Alissa M Conklin, Indiana University
- Investigators
- Alissa M Conklin, MD, Principal investigator, Indiana School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07290517
- Sponsor's protocol ID
- 25731
- Acronym
- CARE
- Status last verified
- Jun 2026
- First submitted
- 11 Dec 2025
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Yaron M, Legardeur H, Barcellini B, Akhoundova F, Mathevet P. Safety and efficacy of a suction cervical stabilizer for intrauterine contraceptive device insertion: Results from a randomized, controlled study. Contraception. 2023 Jul;123:110004. doi: 10.1016/j.contraception.2023.110004. Epub 2023 Mar 11.
PubMed 36914147