Novel Cervical Retraction Device

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

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.

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