Novel Cervical Retraction Device

Status unconfirmed · Not applicable

Conditions studied: Pain Due to Certain Specified Procedures

In brief

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.

Key facts

Study ID

NCT02283463

Run by

Bioceptive

People needed

24

Starts

2014-09-01

Last updated by the study team

2017-07-19

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Subjects presenting for IUD insertion or endometrial biopsy
• Able to consent for study in English or Spanish

You may not qualify if…

• Post-menopausal
• Current pregnancy
• Cervical abnormalities (cervical polyp, cervical lesion, or irregularity)
• Use of narcotics or Benzodiazepines prior to procedure

Where it is running

• University of Utah, School of Medicine — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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