Assessing Pain and Effectiveness of Carevix Device for IUD Insertions

NCT ID: NCT07290517

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2027-02-28

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Carevix

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

Group Type: EXPERIMENTAL

Carevix

Intervention Type: DEVICE

Vacuum cervical stabilization device

Tenaculum

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

Group Type: ACTIVE_COMPARATOR

Tenaculum

Intervention Type: DEVICE

Standard of care cervical stabilization device

Interventions

Carevix

Vacuum cervical stabilization device

Intervention Type: DEVICE

Tenaculum

Standard of care cervical stabilization device

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Aspivix SA

INDUSTRY

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Alissa M Conklin

Assistant Professor of Clinical Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alissa M Conklin, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana School of Medicine

Locations

Indiana University Hospital

Indianapolis, Indiana, United States

Countries

United States

Central Contacts

Alissa M Conklin, MD

Role: CONTACT

alconkli@iu.edu

317-944-8231

Kylie L Williams, MA

Role: CONTACT

kylowill@iu.edu

Facility Contacts

Alissa M Conklin, MD

Role: primary

alconkli@iu.edu

317-944-8231

References

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.

Reference Type: BACKGROUND

PMID: 36914147 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

https://pubmed.ncbi.nlm.nih.gov/36914147/

Sponsor journal article

Other Identifiers

25731

Identifier Type: -

Identifier Source: org_study_id