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Novel Cervical Retraction Device

Pain Due to Certain Specified Procedures Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • Pain Due to Certain Specified Procedures
Clinical Trial Details
NCT number NCT02283463
Study type Interventional
Source Bioceptive
Contact
Status Active, not recruiting
Phase N/A
Start date September 2014
View Details
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