Novel Cervical Retraction Device

• ClinicalTrials.gov Identifier: NCT02283463
• Recruitment Status: Unknown
• First Posted: November 5, 2014
• Last Update Posted: July 19, 2017
• Sponsor: Bioceptive
• Information provided by (Responsible Party): Bioceptive

Tracking Information

• First Submitted Date: October 30, 2014
• First Posted Date: November 5, 2014
• Last Update Posted Date: July 19, 2017
• Study Start Date: September 2014
• Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Novel Cervical Retraction Device
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Prevention
• Condition: Pain Due to Certain Specified Procedures

Intervention

• Device: Intrauterine device (IUD) insertion
• Procedure: Endometrial biopsy

Study Arms

• 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:bmjsrh-2017-200031. doi: 10.1136/bmjsrh-2017-200031. Online ahead of print.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: November 4, 2014): 24
• Original Estimated Enrollment: Same as current
• Study Completion Date: Not Provided
• Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02283463
• Other Study ID Numbers: AB001
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Bioceptive
• Original Responsible Party: Same as current
• Current Study Sponsor: Bioceptive
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: David Turok, MD, MPH; University of Utah, Dept. of Obstetrics and Gynecology

• PRS Account: Bioceptive
• Verification Date: July 2017