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Procedure

Carevix for Abnormal Uterine Bleeding

N/A

Recruiting

Led By Alissa Conklin, MD

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 years or older

Cervix at least 26 mm in diameter

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately after intrauterine procedure is complete

Awards & highlights

Study Summary

This trial will compare a new device called a suction cervical stabilizer to the standard device called a single-tooth tenaculum. The new device has been approved by the FDA and has been shown to

Who is the study for?

This trial is for individuals undergoing intrauterine procedures like IUD insertion or experiencing abnormal uterine bleeding. Participants should be eligible for the procedure and not have any health conditions that would exclude them from safely using either the suction cervical stabilizer (Carevix) or the standard tenaculum.Check my eligibility

What is being tested?

The study compares patient pain, bleeding, and device efficiency between two devices: a new FDA-approved suction cervical stabilizer called Carevix, which is less traumatic, and a traditional single-tooth tenaculum used in these procedures.See study design

What are the potential side effects?

While specific side effects are not listed, it's implied that the traditional tenaculum may cause more pain and bleeding compared to Carevix. The new device aims to reduce these issues significantly based on previous European studies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My cervix is at least 26 mm wide.

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I will have a procedure using Carevix or Tenaculum.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately after intrauterine procedure is complete

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately after intrauterine procedure is complete

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after intrauterine procedure is complete for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Patient-perceived pain

Secondary outcome measures

Provider-perceived bleeding

Provider-perceived ease of use

Provider-perceived satisfaction

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CarevixExperimental Treatment1 Intervention

suction cervical stabilizer utilized for intrauterine procedures

Group II: TenaculumActive Control1 Intervention

standard of care cervical stabilization device

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

981,710 Total Patients Enrolled

1 Trials studying Abnormal Uterine Bleeding

380 Patients Enrolled for Abnormal Uterine Bleeding

Alissa Conklin, MDPrincipal InvestigatorIndiana University School of Medicine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals being admitted into this research investigation?

"Indeed, the information available on clinicaltrials.gov confirms that this study is actively seeking participants. The trial was initially posted on November 9th, 2023 and has been recently updated on December 20th, 2023. This clinical trial aims to enroll a total of 52 patients across one site."

Answered by AI

Are patients currently eligible to participate in this ongoing medical study?

"Indeed, the details provided on clinicaltrials.gov indicate that this trial is actively seeking eligible candidates. The initial posting of the clinical trial was made on November 9th, 2023 and it was last modified on December 20th, 2023. The study aims to enroll a total of 52 participants at a single designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Suction Cervical Stabilizer Compared to Standard Tenaculum for Intrauterine Procedures

Alissa M Conklin 2023. "Suction Cervical Stabilizer Compared to Standard Tenaculum for Intrauterine Procedures". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06193590.

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