Novel Cervical Retraction Device

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02283463

Enrollment

Registered

2014-11-05

Start date

2014-09-30

Completion date

Unknown

Last updated

2017-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain Due to Certain Specified Procedures

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.

Interventions

DEVICEIntrauterine device (IUD) insertion

PROCEDUREEndometrial biopsy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Pain Intensity Measure 100 point visual analogue scale	1 day	Pain recorded by patient during the procedure and one day following via 100 point visual analogue scale. (0 = none, 100 = worst imaginable)

Secondary

Measure	Time frame	Description
Procedural Satisfaction Patient records level of satisfaction with the procedure (Very Unsatisfied, Unsatisfied, Neutral, Satisfied, Very Satisfied)	< 1 hour	Patient records level of satisfaction with the procedure (Very Unsatisfied, Unsatisfied, Neutral, Satisfied, Very Satisfied)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026