Uretal Flow Assessment During Gynecological Procedures

NCT ID: NCT00453882

Last Updated: 2012-01-30

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

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-04-30

Brief Summary

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The objective is to evaluate the feasibility of using color Doppler ultrasound in ureteral flow assessment after uterine artery occlusion during a conservative gynecological procedure.

Detailed Description

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Conditions

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Conservative Gynecological Procedures

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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flostat (TM) System

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Meets criteria for conservative gynecological procedure
* At least 25 years of age
* Cervix suitable for tenaculum placement
* Provides written informed consent.

Exclusion Criteria

* Pregnancy
* One or more lower uterine segment fibroids
* Hydronephrosis as determined by renal ultrasound pre-procedurally
* Clinical diagnosis of urinary tract infection (UTI)
* In the medical judgment of the physician, such a procedure may compromise the patient's condition
* Inability to achieve bilateral occlusion with the clamp placement during the procedure.
Minimum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ethicon, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Robinson, MD

Role: STUDY_DIRECTOR

Ethicon, Inc.

Locations

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Holy Cross Medical Group

Fort Lauderdale, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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300-06-003

Identifier Type: -

Identifier Source: org_study_id

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