Novel Cervical Retraction Device



Status:Active, not recruiting
Healthy:No
Age Range:18 - 45
Updated:7/20/2017
Start Date:September 2014

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Trial Summary
Trial Overview
Inclusion Criteria

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
We found this trial at
1
site
University of Utah School of Medicine
Salt Lake City, Utah 84132
?
mi
from
Salt Lake City, UT
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