Suction Cervical Stabilizer Compared to Standard Tenaculum for Intrauterine Procedures

Safety and Efficacy of a Suction Cervical Stabilizer Compared to the Standard Tenaculum for Intrauterine Procedures in the Clinic Setting

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.

Study Overview

• Status: Completed
• Conditions: Abnormal Uterine Bleeding; Intrauterine Device (IUD)
• Intervention / Treatment: Device: Carevix; Device: Tenaculum

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• • 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

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
  • Pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Carevix; suction cervical stabilizer utilized for intrauterine procedures	Device: Carevix; Cervical stabilization device that uses vacuum
Active Comparator: Tenaculum; standard of care cervical stabilization device	Device: Tenaculum; standard of care cervical stabilization device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Provider-perceived Bleeding	Bleeding perceived by the provider during and after the procedure.	Immediately after intrauterine procedure and scheduled appointment is complete (approx. 5-10 minutes after procedure completion)
Provider-perceived Ease of Use	Providers will report their perceived ease of use with the Carevix device indicating "Strongly Disagree, Disagree, Agree, or Strongly Agree" and open response.	Immediately after intrauterine procedure and scheduled appointment is complete (approx. 5-10 minutes after procedure completion)
Provider-perceived Satisfaction	Providers will report their perceived satisfaction indicating "Strongly Disagree, Disagree, Agree, or Strongly Agree" and open response. In the Tenaculum arm, providers reported if they preferred the cervical tenaculum to the Carevix device. Providers complete their portion of the survey after the appointment is concluded.	Immediately after intrauterine procedure and scheduled appointment is complete (approx. 5-10 minutes after procedure completion)

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: Alissa Conklin, MD, Indiana University 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

• journal article

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2023
• Primary Completion (Actual): April 15, 2024
• Study Completion (Actual): April 15, 2024

Study Registration Dates

• First Submitted: December 4, 2023
• First Submitted That Met QC Criteria: December 20, 2023
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): June 10, 2025
• Last Update Submitted That Met QC Criteria: May 22, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Hemorrhage; Uterine Hemorrhage
• Other Study ID Numbers: 19699

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