Uretal Flow Assessment During Gynecological Procedures

Ethicon

Status: Completed

Conditions: Conservative Gynecological Procedures

Treatments: Device: flostat (TM) System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00453882

300-06-003

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: Female

Ages: 25+ years old

Volunteers: No Healthy Volunteers

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.