Novel Cervical Retraction Device

Not Applicable

• Conditions: Pain Due to Certain Specified Procedures
• Interventions: Device: Intrauterine device (IUD) insertion; Procedure: Endometrial biopsy

• Registration Number: NCT02283463
• Lead Sponsor: Bioceptive

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-10-30
• Study First Submitted QC: 2014-11-04
• Study First Posted: 2014-11-05
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-18
• Last Update Posted: 2017-07-19
• Primary Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Cervical Tenaculum	Endometrial biopsy	Single tooth tenaculum, pierces the tissue of the cervix to allow provider to stabilize and place traction on the cervical cal/uterus
Standard Cervical Tenaculum	Intrauterine device (IUD) insertion	Single tooth tenaculum, pierces the tissue of the cervix to allow provider to stabilize and place traction on the cervical cal/uterus
Bioceptive Cervical Retraction Device	Intrauterine device (IUD) insertion	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.
Bioceptive Cervical Retraction Device	Endometrial biopsy	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.

Primary Outcome Measures

Name	Time	Method
Pain Intensity Measure 100 point visual analogue scale	1 day	Pain recorded by patient during the procedure and one day following via 100 point visual analogue scale. (0 = none, 100 = worst imaginable)

Secondary Outcome Measures

Name	Time	Method
Procedural Satisfaction Patient records level of satisfaction with the procedure (Very Unsatisfied, Unsatisfied, Neutral, Satisfied, Very Satisfied)	< 1 hour	Patient records level of satisfaction with the procedure (Very Unsatisfied, Unsatisfied, Neutral, Satisfied, Very Satisfied)

Trial Locations

Locations (1)

University of Utah, School of Medicine; 🇺🇸 Salt Lake City, Utah, United States