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| Name | Class |
|---|---|
| Aspivix SA | INDUSTRY |
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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:
Participants (including providers) will:
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 Carevixâ„¢ 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 Carevixâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carevix | Experimental | Patients will receive the atraumatic, suction-based, cervical stabilizer (Carevix) for their IUD insertion. |
|
| Tenaculum | Active Comparator | Patients will receive the standard of care device (single tooth tenaculum) for their IUD insertion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carevix | Device | Vacuum cervical stabilization device |
| |
| Tenaculum |
| Measure | Description | Time Frame |
|---|---|---|
| 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." | 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 | 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. | 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, with 0 = no pain expected. | Within 15 minutes after IUD procedure completion |
| Measure | Description | Time Frame |
|---|---|---|
| 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" | Immediately after IUD procedure |
| Provider device satisfaction - Impact on Patient Discomfort |
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Inclusion Criteria (to be assessed prior to procedure):
Exclusion Criteria (to be assessed by provider at time of procedure):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alissa M Conklin, MD | Contact | 317-944-8231 | alconkli@iu.edu | |
| Kylie L Williams, MA | Contact | kylowill@iu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Alissa M Conklin, MD | Indiana School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Hospital | Recruiting | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36914147 | Background | 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. |
| Label | URL |
|---|---|
| Sponsor journal article | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 9, 2025 | Dec 16, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 25, 2025 | Dec 16, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D008796 | Metrorrhagia |
| D019547 | Neck Pain |
| D010146 | Pain |
| ID | Term |
|---|---|
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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Patients will be randomized, but are unable to be blinded.
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| Device |
Standard of care cervical stabilization device |
|
Providers will be asked whether the device's use impacted patient discomfort on a 5 point Likert scale from "Strongly Disagree"-"Strongly Agree." |
| 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" | 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" | 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" | 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." | Immediately after IUD procedure |
| Number of Device Placement Attempts | Providers are asked to report the number of attempts required for device placement | 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 | 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. | 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. | 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." | 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 Very Dissatisfied to Very Satisfied. | Immediately after IUD procedure completion |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |