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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 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

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Who is running the clinical trial?

Indiana UniversityLead Sponsor
994 Previous Clinical Trials
1,095,109 Total Patients Enrolled
1 Trials studying Abnormal Uterine Bleeding
380 Patients Enrolled for Abnormal Uterine Bleeding
Alissa Conklin, MDPrincipal InvestigatorIndiana University School of Medicine
~0 spots leftby Jun 2024
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