Novel Cervical Retraction Device

Pain Due to Certain Specified Procedures Clinical Trial

Official title:

Patient Discomfort With a Novel Suction Based Cervical Retractor Compared to the Traditional Cervical Tenaculum

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02283463
• Other study ID #: AB001
• Status: Active, not recruiting
• Phase: N/A
• First received: October 30, 2014
• Last updated: July 18, 2017
• Start date: September 2014

Study information

• Verified date: July 2017
• Source: Bioceptive
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. primary completion date: February 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain Due to Certain Specified Procedures

Intervention

Device:
• Intrauterine device (IUD) insertion

Procedure:
• Endometrial biopsy

Locations

Country	Name	City	State
United States	University of Utah, School of Medicine	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Bioceptive

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	< 1 hour