Assessing Pain and Effectiveness of Carevix Device for IUD Insertions

NCT07290517 | Recruiting DMC FDA Device

• 1 other identifier: 25731
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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). 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

Conditions

IUD; Pain, Cervical; Abnormal Uterine Bleeding

Keywords

IUD insertion; Cervical Stabilization; Tenaculum; Pain

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (12)

• Provider device satisfaction - Time to Use Device

  Immediately after IUD procedure

• Provider device satisfaction - Impact on Patient Discomfort

  Immediately after IUD insertion procedure

• Provider device satisfaction - Device Preference

  Immediately after IUD insertion procedure

• Provider device satisfaction - Procedure Visibility

  Immediately after IUD insertion procedure

• Provider device satisfaction - Pulling Strength

  Immediately after IUD insertion procedure

Study Arms (2)

Carevix

EXPERIMENTAL

Patients will receive the atraumatic, suction-based, cervical stabilizer (Carevix) for their IUD insertion.

Device: Carevix

Tenaculum

ACTIVE COMPARATOR

Patients will receive the standard of care device (single tooth tenaculum) for their IUD insertion.

Device: Tenaculum

Interventions

Carevix DEVICE

Vacuum cervical stabilization device

Carevix

Tenaculum DEVICE

Standard of care cervical stabilization device

Tenaculum

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aspivix SA: collaborator
• Indiana University: lead

Study Sites (1)

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 36914147 BACKGROUND

Related Links

• Sponsor journal article

MeSH Terms

Conditions

Metrorrhagia; Neck Pain; Pain

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Alissa M Conklin, MD

  Indiana School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alissa M Conklin, MD

CONTACT

317-944-8231; alconkli@iu.edu

Kylie L Williams, MA

CONTACT

kylowill@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Patients will be randomized, but are unable to be blinded.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Obstetrics and Gynecology

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 18, 2025
• Study Start: March 11, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)