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Novel Cervical Retraction Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02283463
Recruitment Status : Unknown
Verified July 2017 by Bioceptive.
Recruitment status was:  Active, not recruiting
First Posted : November 5, 2014
Last Update Posted : July 19, 2017
Sponsor:
Information provided by (Responsible Party):
Bioceptive

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pain Due to Certain Specified Procedures Device: Intrauterine device (IUD) insertion Procedure: Endometrial biopsy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Patient Discomfort With a Novel Suction Based Cervical Retractor Compared to the Traditional Cervical Tenaculum
Study Start Date : September 2014
Estimated Primary Completion Date : February 2018
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Standard Cervical Tenaculum
Single tooth tenaculum, pierces the tissue of the cervix to allow provider to stabilize and place traction on the cervical cal/uterus
 Device: Intrauterine device (IUD) insertion
Procedure: Endometrial biopsy
Experimental: Bioceptive Cervical Retraction Device
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.
 Device: Intrauterine device (IUD) insertion
Procedure: Endometrial biopsy


Outcome Measures
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Primary Outcome Measures :
  1. Pain Intensity Measure 100 point visual analogue scale [ Time Frame: 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 :
  1. Procedural Satisfaction Patient records level of satisfaction with the procedure (Very Unsatisfied, Unsatisfied, Neutral, Satisfied, Very Satisfied) [ Time Frame: < 1 hour ]
    Patient records level of satisfaction with the procedure (Very Unsatisfied, Unsatisfied, Neutral, Satisfied, Very Satisfied)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02283463


Locations
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United States, Utah
University of Utah, School of Medicine
Salt Lake City, Utah, United States, 84106
Sponsors and Collaborators
Bioceptive
Investigators
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Principal Investigator: David Turok, MD, MPH University of Utah, Dept. of Obstetrics and Gynecology
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bioceptive
ClinicalTrials.gov Identifier: NCT02283463    
Other Study ID Numbers: AB001
First Posted: November 5, 2014    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: July 2017