Novel Cervical Retraction Device

Bioceptive

Status: Unknown

Conditions: Pain Due to Certain Specified Procedures

Treatments: Procedure: Endometrial biopsy; Device: Intrauterine device (IUD) insertion

Study type: Interventional

Funder types: Industry

Identifiers

NCT02283463

AB001

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Standard Cervical Tenaculum

Active Comparator group

Description:

Single tooth tenaculum, pierces the tissue of the cervix to allow provider to stabilize and place traction on the cervical cal/uterus

Treatment:

Device: Intrauterine device (IUD) insertion

Procedure: Endometrial biopsy

Bioceptive Cervical Retraction Device

Experimental group

Description:

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.

Treatment:

Device: Intrauterine device (IUD) insertion

Procedure: Endometrial biopsy