Novel Cervical Retraction Device

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Pain Due to Certain Specified Procedures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Intrauterine device (IUD) insertion

Intervention Type DEVICE

Endometrial biopsy

Intervention Type PROCEDURE

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.

Group Type EXPERIMENTAL

Intrauterine device (IUD) insertion

Intervention Type DEVICE

Endometrial biopsy

Intervention Type PROCEDURE

Interventions

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Intrauterine device (IUD) insertion

Intervention Type DEVICE

Endometrial biopsy

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes