Carevix for IUD Therapy
(CARE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two tools for IUD (a birth control device) insertion to determine which causes less pain and is easier for healthcare providers to use. The Carevix Device, a new gentle suction device, is compared to the standard tool, the Tenaculum, which can be more uncomfortable. The trial will gather feedback from both patients and providers on pain, bleeding, and ease of use. The study seeks women planning to get an IUD inserted soon, with healthcare providers open to using the new device.
As an unphased trial, this study offers a unique opportunity to contribute to developing more comfortable IUD insertion methods.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.
What prior data suggests that the Carevix device is safe for IUD insertion?
Research has shown that the Carevix device is safe for use when inserting IUDs. In earlier studies, 94% of IUD insertions using Carevix succeeded. Patients reported significantly less pain compared to the usual method, with pain scores averaging at least 14 points lower. The device also reduces bleeding during the procedure. These results suggest that patients tolerate Carevix well. The FDA has already approved the device, further confirming its safety.12345
Why are researchers excited about this trial?
Unlike the standard tenaculum used for IUD insertions, which can be uncomfortable and invasive, the Carevix device offers a gentler approach. Carevix is an atraumatic, suction-based cervical stabilizer, which means it stabilizes the cervix without the need for sharp instruments. Researchers are excited about Carevix because it has the potential to reduce discomfort and improve the overall experience for patients undergoing IUD insertion.
What evidence suggests that these devices are effective for IUD insertion?
In this trial, participants will receive either the Carevix device or the standard tenaculum for their IUD insertion. Research has shown that the Carevix device can reduce pain during IUD insertion. Specifically, studies found that patients experienced 52% less pain compared to the traditional tool. Additionally, 88% fewer women who have never given birth reported severe pain with Carevix. The device succeeded in 93% of procedures without requiring additional tools. These findings suggest that Carevix effectively reduces discomfort and aids in IUD insertions.12567
Who Is on the Research Team?
Alissa M Conklin, MD
Principal Investigator
Indiana School of Medicine
Are You a Good Fit for This Trial?
This trial is for individuals experiencing heavy periods or chronic neck pain who are undergoing IUD therapy. Participants must be eligible for an IUD insertion and willing to complete a survey post-procedure. Specific details on inclusion and exclusion criteria were not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo IUD insertion using either the Carevix device or the tenaculum, followed by a survey
Follow-up
Participants are monitored for pain, bleeding, and device efficiency immediately after the procedure
What Are the Treatments Tested in This Trial?
Interventions
- Carevix Device
- Tenaculum
Trial Overview
The study compares two methods of stabilizing the cervix during IUD insertions: Carevix, a new FDA-approved suction device that's less traumatic, versus the standard single-tooth tenaculum which can cause more discomfort.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Patients will receive the atraumatic, suction-based, cervical stabilizer (Carevix) for their IUD insertion.
Patients will receive the standard of care device (single tooth tenaculum) for their IUD insertion.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Indiana University
Lead Sponsor
Aspivix SA
Industry Sponsor
Citations
Clinical data show significantly lower IUD procedural pain ...
Pain scores were 52% lower with the Carevix® device during cervix grasping, 53% lower during cervix stabilization (traction), 30% lower during ...
Safety and efficacy of a suction cervical stabilizer for IUD ...
Our data support previous findings that reported an 83% successful insertion rate with Carevix, comparable to the 82% observed in our study.
ASPIVIX Announces That Contraception, an International ...
During IUD insertion, in the Carevix® group 88% less nulliparous women reported severe pain than in the tenaculum group.1; Cervix bleeding ...
Assessing Pain and Effectiveness of Carevix Device for ...
The goal of this clinical trial is to evaluate patient-reported pain, bleeding, and device efficiency along with provider satisfaction and ease ...
Real world performance of an atraumatic cervical stabiliser ...
The procedure was successfully completed using Carevix alone in 93% of cases. In five cases (7%), a tenaculum was required: twice due to ...
Safety and efficacy of a suction cervical stabilizer for IUD ...
IUD insertions using Carevix device were documented for completion rates, patient-reported pain scores, cervical bleeding, and operator and ...
Safety and efficacy of a suction cervical stabilizer for ...
IUD insertion was successful in 94% of all subjects. Subjects in the investigational device group reported pain scores ≥14 points lower than in the control ...
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