Suction Cervical Stabilizer Compared to Standard Tenaculum for Intrauterine Procedures

NCT06193590 | Completed Results DMC FDA Device

• 1 other identifier: 19699
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate patient-reported pain, bleeding, and device efficiency along with provider satisfaction and ease of use between intrauterine procedures employing a suction cervical stabilizer (new device, FDA approved, atraumatic) or single-tooth tenaculum (standard, traumatic). This device, cleared by the FDA in 2023, was studied in Europe and showed pain reduced by up to 73% and bleeding reduced by 78% compared to the single-tooth tenaculum for intrauterine contraceptive device insertion. The investigators seek to study this device in the United States, and trial it among all intrauterine procedures.

Conditions

Intrauterine Device (IUD); Abnormal Uterine Bleeding

Outcome Measures

Primary Outcomes (1)

• Patient-perceived Pain

  Patients will be asked to rate their pain using the Numeric Rating Scale, a pain screening tool commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable". Participants fill out their survey once the procedure and clinical appointment is concluded.

  Immediately after intrauterine procedure and scheduled appointment is complete (approx. 5-10 minutes after procedure completion)

Secondary Outcomes (3)

• Provider-perceived Bleeding

  Immediately after intrauterine procedure and scheduled appointment is complete (approx. 5-10 minutes after procedure completion)

• Provider-perceived Ease of Use

  Immediately after intrauterine procedure and scheduled appointment is complete (approx. 5-10 minutes after procedure completion)

• Provider-perceived Satisfaction

  Immediately after intrauterine procedure and scheduled appointment is complete (approx. 5-10 minutes after procedure completion)

Study Arms (2)

Carevix

EXPERIMENTAL

suction cervical stabilizer utilized for intrauterine procedures

Device: Carevix

Tenaculum

ACTIVE COMPARATOR

standard of care cervical stabilization device

Device: Tenaculum

Interventions

Carevix DEVICE

Cervical stabilization device that uses vacuum

Carevix

Tenaculum DEVICE

standard of care cervical stabilization device

Tenaculum

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Speaks and reads in English
• Able to consent on their own
• Will undergo any intrauterine procedure using the Carevix (for exposure group) or using Tenaculum (for Control Group)
• Cervix at least 26 mm in diameter
• Twenty providers performing this 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
• Pregnant

Sponsors & Collaborators

• 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

• journal article

MeSH Terms

Conditions

Metrorrhagia

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

Limitations and Caveats

Not all clinic providers wanted to participate in the trial which hindered recruitment. Similarly, not all providers consistently utilized ANY cervical stabilization which rendered otherwise eligible participants unable to continue in the study.

Results Point of Contact

• Title: Dr. Alissa M Conklin
• Organization: Indiana University Health

alconkli@iu.edu

317.944.8231

Study Officials

• Alissa Conklin, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Obstetrics and Gynecology

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: January 5, 2024
• Study Start: November 9, 2023
• Primary Completion: April 15, 2024
• Study Completion: April 15, 2024
• Last Updated: June 10, 2025
• Results First Posted: June 10, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)