Suction Cervical Stabilizer Compared to Standard Tenaculum for Intrauterine Procedures

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-09

Study Completion Date

2024-04-15

Brief Summary

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To evaluate patient-reported pain, bleeding, and device efficiency along with provider satisfaction and ease of use between intrauterine procedures employing a suction cervical stabilizer (new device, FDA approved, atraumatic) or single-tooth tenaculum (standard, traumatic). This device, cleared by the FDA in 2023, was studied in Europe and showed pain reduced by up to 73% and bleeding reduced by 78% compared to the single-tooth tenaculum for intrauterine contraceptive device insertion. The investigators seek to study this device in the United States, and trial it among all intrauterine procedures.

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Detailed Description

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Conditions

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Intrauterine Device (IUD) Abnormal Uterine Bleeding

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Carevix

suction cervical stabilizer utilized for intrauterine procedures

Group Type EXPERIMENTAL

Carevix

Intervention Type DEVICE

Cervical stabilization device that uses vacuum

Tenaculum

standard of care cervical stabilization device

Group Type ACTIVE_COMPARATOR

Tenaculum

Intervention Type DEVICE

standard of care cervical stabilization device

Interventions

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Carevix

Cervical stabilization device that uses vacuum

Intervention Type DEVICE

Tenaculum

standard of care cervical stabilization device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* • Age 18 years or older

* Speaks and reads in English
* Able to consent on their own
* Will undergo any intrauterine procedure using the Carevix (for exposure group) or using Tenaculum (for Control Group)
* Cervix at least 26 mm in diameter
* Twenty providers performing this procedure

Exclusion Criteria

* • Vaginal bleeding of unknown origin

* Cervix less than 26 mm in diameter
* Nabothian cyst on anterior lip of cervix
* Cervical myomas
* Cervical abnormalities
* Pregnant

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes