Uretal Flow Assessment During Gynecological Procedures | NCT00453882

Studies
Uretal Flow Assessment During Gynecological Procedures

NCT00453882

Sponsor

Ethicon, Inc.

Status

Completed

Last Update Posted

Jan 30, 2012Estimated

Enrollment

7Actual

Phase

Not Applicable

Conditions

Conservative Gynecological Procedures

Interventions

flostat (TM) System

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2006

Primary Completion Date

Apr 2007Actual

Completion Date

Apr 2007Actual

First Submitted Date

Mar 28, 2007

First Submission Date that Met QC Criteria

Mar 28, 2007

First Posted Date

Mar 29, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2012

Last Update Posted Date

Jan 30, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Name	Type	Description	Arm Group Labels	Other Names
flostat (TM) System	Device

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Robinson, MD	Ethicon, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Holy Cross Medical Group		Fort Lauderdale	Florida	33308	United States

Intervention Browse Module

MeSH Terms

ID	Term
D016503	Drug Delivery Systems

Ancestor Terms

ID	Term
D004358	Drug Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
Ability to evaluate ureteric jets
Adverse events