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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

Tracking Information
First Submitted Date  ICMJE October 30, 2014
First Posted Date  ICMJE November 5, 2014
Last Update Posted Date July 19, 2017
Study Start Date  ICMJE September 2014
Estimated Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2014)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2014)
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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Novel Cervical Retraction Device
Official Title  ICMJE Patient Discomfort With a Novel Suction Based Cervical Retractor Compared to the Traditional Cervical Tenaculum
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Pain Due to Certain Specified Procedures
Intervention  ICMJE
  • Device: Intrauterine device (IUD) insertion
  • Procedure: Endometrial biopsy
Study Arms  ICMJE
  • 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
    Interventions:
    • 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.
    Interventions:
    • Device: Intrauterine device (IUD) insertion
    • Procedure: Endometrial biopsy
Publications * Turok DK, Simmons RG, Cappiello B, Gawron LM, Saviers-Steiger J, Sanders JN. Use of a novel suction cervical retractor for intrauterine device insertion: a pilot feasibility trial. BMJ Sex Reprod Health. 2018 Nov 5. pii: bmjsrh-2017-200031. doi: 10.1136/bmjsrh-2017-200031. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 4, 2014)
24
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02283463
Other Study ID Numbers  ICMJE AB001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bioceptive
Study Sponsor  ICMJE Bioceptive
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Turok, MD, MPH University of Utah, Dept. of Obstetrics and Gynecology
PRS Account Bioceptive
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP