Novel Cervical Retraction Device

Bioceptive24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Pain Due to Certain Specified Procedures

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

Time frame: 1 day

Secondary Outcomes

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

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

Time frame: < 1 hour