Assessing Pain and Effectiveness of Carevix Device for IUD Insertions

NCT07290517 | Not Yet 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 (1)

• Patient pain score (Numeric Pain Rating Scale)

  0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"

  During IUD insertion procedure

Secondary Outcomes (2)

• Provider device satisfaction

  Immediately after IUD insertion procedure

• Reason for IUD procedure

  Immediately after IUD insertion procedure

Other Outcomes (3)

• Predictors for pain score

  Immediately after IUD insertion procedure

• Patient pain score at device placement, prior to IUD insertion (Numeric Pain Rating Scale)

  During IUD insertion procedure

• Patient pain score after completion of IUD insertion procedure (Numeric Pain Rating Scale)

  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

Location

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: February 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 14, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)