Novel Cervical Retraction Device

Study Overview
=================
Brief Summary
-----------------
This study will test a suction-based method of engaging the cervix. Bioceptive has developed a device that more gently and atraumatically attaches to the cervix with no bleeding. This novel attachment mechanism may diminish pain and discomfort. Pre-clinical testing has been performed on the device including testing on synthetic uterine models, human cadavers, and human uteri immediately post-hysterectomy (Utah IRB # 00059096). Results from these efforts have shown effective attachment to the cervix and the ability for the device to maintain suction throughout a procedure atraumatically. This study proposes to introduce this minimal risk device in a clinical setting to determine the response of women undergoing gynecologic procedures.

Official Title
-----------------
Patient Discomfort With a Novel Suction Based Cervical Retractor Compared to the Traditional Cervical Tenaculum

Conditions
-----------------
Pain Due to Certain Specified Procedures

Intervention / Treatment
-----------------
* Device: Intrauterine device (IUD) insertion
* Procedure: Endometrial biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects presenting for IUD insertion or endometrial biopsy Able to consent for study in English or Spanish Exclusion Criteria: Post-menopausal Current pregnancy Cervical abnormalities (cervical polyp, cervical lesion, or irregularity) Use of narcotics or Benzodiazepines prior to procedure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Cervical Tenaculum<br>Single tooth tenaculum, pierces the tissue of the cervix to allow provider to stabilize and place traction on the cervical cal/uterus | Device: Intrauterine device (IUD) insertion<br> <br> Procedure: Endometrial biopsy<br> <br> |
| Experimental: Bioceptive Cervical Retraction Device<br>Suction based method for stabilizing the cervix and uterus. Achieves suction 360 degrees around cervical os creating a portal through which instruments can be passed into the cervical canal and uterus. Provider can still place traction on uterus with this device just as with tenaculum. | Device: Intrauterine device (IUD) insertion<br> <br> Procedure: Endometrial biopsy<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity Measure 100 point visual analogue scale | Pain recorded by patient during the procedure and one day following via 100 point visual analogue scale. (0 = none, 100 = worst imaginable) | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Satisfaction Patient records level of satisfaction with the procedure (Very Unsatisfied, Unsatisfied, Neutral, Satisfied, Very Satisfied) | Patient records level of satisfaction with the procedure (Very Unsatisfied, Unsatisfied, Neutral, Satisfied, Very Satisfied) | < 1 hour |