NCT02283463

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 5, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Last Updated

July 19, 2017

Status Verified

July 1, 2017

Enrollment Period

3.4 years

First QC Date

October 30, 2014

Last Update Submit

July 18, 2017

Conditions

Pain Due to Certain Specified Procedures

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity Measure 100 point visual analogue scale

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

    1 day

Secondary Outcomes (1)

  • Procedural Satisfaction Patient records level of satisfaction with the procedure (Very Unsatisfied, Unsatisfied, Neutral, Satisfied, Very Satisfied)

    < 1 hour

Study Arms (2)

Standard Cervical Tenaculum

ACTIVE COMPARATOR

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) insertionProcedure: Endometrial biopsy

Bioceptive Cervical Retraction Device

EXPERIMENTAL

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) insertionProcedure: Endometrial biopsy

Interventions

Intrauterine device (IUD) insertionDEVICE
Bioceptive Cervical Retraction DeviceStandard Cervical Tenaculum
Endometrial biopsyPROCEDURE
Bioceptive Cervical Retraction DeviceStandard Cervical Tenaculum

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects presenting for IUD insertion or endometrial biopsy
  • Able to consent for study in English or Spanish

You may not qualify if:

  • Post-menopausal
  • Current pregnancy
  • Cervical abnormalities (cervical polyp, cervical lesion, or irregularity)
  • Use of narcotics or Benzodiazepines prior to procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah, School of Medicine

Salt Lake City, Utah, 84106, United States

Location

Related Publications (1)

  • 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.

    PMID: 30396906DERIVED

MeSH Terms

Interventions

Intrauterine DevicesMutagenesis, Insertional

Intervention Hierarchy (Ancestors)

Contraceptive Devices, FemaleContraceptive DevicesEquipment and SuppliesProtein EngineeringGenetic EngineeringGenetic TechniquesInvestigative TechniquesMutationGenetic VariationGenetic PhenomenaMutagenesis

Study Officials

  • David Turok, MD, MPH

    University of Utah, Dept. of Obstetrics and Gynecology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2014

First Posted

November 5, 2014

Study Start

September 1, 2014

Primary Completion

February 1, 2018

Last Updated

July 19, 2017

Record last verified: 2017-07

Locations

US(1)