Assessing Pain and Effectiveness of Carevix Device for IUD Insertions (CARE)

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

Participants (including providers) will:

• be randomized to receive one device to complete the IUD procedure
• complete a survey following the procedure

Study Overview

• Status: Recruiting
• Conditions: Abnormal Uterine Bleeding; IUD; Pain, Cervical
• Intervention / Treatment: Device: Carevix; Device: Tenaculum

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kylie L Williams, MA; Email: kylowill@iu.edu
• Study Contact Backup: Name: Alissa M Conklin, MD; Phone Number: 317-944-8231; Email: alconkli@iu.edu

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana University Hospital
      • Contact: Alissa M Conklin, MD; Phone Number: 317-944-8231; Email: alconkli@iu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion 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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Carevix; Patients will receive the atraumatic, suction-based, cervical stabilizer (Carevix) for their IUD insertion.	Device: Carevix; Vacuum cervical stabilization device
Active Comparator: Tenaculum; Patients will receive the standard of care device (single tooth tenaculum) for their IUD insertion.	Device: Tenaculum; Standard of care cervical stabilization device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable."	Within 15 minutes after IUD procedure completion

Secondary Outcome Measures

Outcome Measure	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	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 5 point Likert scale from "Strongly Disagree"-"Strongly Agree"	Immediately after IUD procedure completion

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictors for pain score	Questionnaire	Immediately after IUD insertion procedure
Patient pain score at device placement, prior to IUD insertion (Numeric Pain Rating Scale)	0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"	During IUD insertion procedure
Patient pain score after completion of IUD insertion procedure (Numeric Pain Rating Scale)	0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"	Immediately after IUD insertion procedure

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: Aspivix SA
• Investigators: Principal Investigator: Alissa M Conklin, MD, Indiana School of Medicine

Publications and helpful links

General 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.

Helpful Links

• Sponsor journal article

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: December 11, 2025
• First Submitted That Met QC Criteria: December 16, 2025
• First Posted (Actual): December 18, 2025

Study Record Updates

• Last Update Posted (Actual): August 13, 2026
• Last Update Submitted That Met QC Criteria: August 11, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Pain; IUD insertion; Tenaculum; Cervical Stabilization
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Neurologic Manifestations; Pathologic Processes; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Hemorrhage; Uterine Hemorrhage; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Neck Pain; Metrorrhagia
• Other Study ID Numbers: 25731

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No