Safety and efficacy of a suction cervical stabilizer compared to the standard tenaculum for intrauterine procedures in the clinic setting.

A
Alissa Conklin

Primary Investigator

Enrolling By Invitation
18 years - 100 years
Female
Phase N/A
26 participants needed
1 Location

Brief description of study

What is the purpose of this study?
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.  We seek to study this device in the United States, and trial it among all intrauterine procedures.

THIS STUDY IS ENROLLING BY INVITATION ONLY - Patients will be approached about study and their eligibility at the time of their already scheduled intrauterine procedure in the clinic at Coleman Center within University Hospital.

Detailed description of study

What will happen during the study?
  • An intrauterine procedure is a medical procedure that takes place inside the uterus. When intrauterine procedures are performed, often the cervix needs to be stabilized to facilitate intrauterine entry. The standard approach for cervical stabilization uses an instrument called a tenaculum. This leaves two punctures on the cervix, which can cause pain and bleeding, and can prolong any intrauterine procedure (IUD insertion, endometrial biopsy, etc.). Aspivix™ has created a suction-based atraumatic cervical stabilizer for use with such intrauterine procedures. The purpose of this study is to evaluate patient-reported pain and provider-reported bleeding, ease of use and efficiency after using the device, called Carevix™, to hold or stabilize the cervix for intrauterine, as compared to Tenaculum (standard of care device). This Carevix device is approved by the FDA as of January 2023.
  • Patients will undergo their planned procedure.  If cervical stabilization is required, instead of using the traditional instrument called the tenaculum, they will have the Carevix™ suction-based cervical stabilizer used instead.  
  • After the completion of the procedure, patients will then be asked to complete a questionnaire about their experience.  This takes, on average, about 1 minute to complete. 
  • This procedure is performed as a one-time only event and study participation will end after this event.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: all
  • Age: 18 years - 100 years
  • Gender: Female

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

Updated on 01 Aug 2024. Study ID: OBGYN-IIR-SCS-ST, 19699
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