Fibered Platinum Coils vs Vascular Plugs in Pelvic Varices Embolization for the Treatment of Pelvic Congestion Syndrome

Pelvic Congestion Syndrome Clinical Trial

Official title:

Fibered Platinum Coils vs Vascular Plugs in Pelvic Varices Embolization for the Treatment of Pelvic Congestion Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02796092
• Other study ID #: GTM-01
• Status: Completed
• Phase: N/A
• First received: May 27, 2016
• Last updated: June 9, 2016
• Start date: February 2014
• Est. completion date: April 2016

Study information

• Verified date: June 2016
• Source: Group of Research in Minimally Invasive Techniques
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

This prospective randomized study compares the safety and efficacy of two different embolizing agents for the treatment of pelvic congestion syndrome: fibered platinum coils and vascular plugs.

Description:

This prospective randomized study compares the safety and efficacy of two embolizing agents for the treatment of pelvic congestion syndrome: fibered platinum coils (Nester coils; Cook Medical) and vascular plugs (Amplatzer vascular plugs II; St. Jude Medical).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2016
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Signed informed consent

• Presence of chronic abdominal or pelvic pain for more than 6 months

• >6 mm pelvic venous caliber measured by transvaginal US

• Presence of venous reflux OR presence of communicating veins assessed by transvaginal Doppler US

Exclusion Criteria:

• Diagnosed gynecological or pelvic pathology: endometriosis, pelvic inflammatory disease, postoperative adhesions, adenomyosis or leiomyoma

• Glomerular filtration rate <60 ml/min

• History of contrast reaction

• Patients not able to be followed up for at least one year

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pelvic Congestion Syndrome
• Syndrome

Intervention

Device:
• Fibered platinum coils

• Vascular plugs

Locations

Country	Name	City	State
Spain	Lozano Blesa University Hospital	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Group of Research in Minimally Invasive Techniques

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in pain	Decrease in subjective pain assessed by VAS (visual analogue scale)	12 months	No
Secondary	Improvement of dyspareunia	Disappearance or improvement of dyspareunia assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO)	12 months	No
Secondary	Improvement of urinary urgency	Disappearance or improvement of urinary urgency assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO)	12 months	No
Secondary	Improvement of dysmenorrhea	Disappearance or improvement of dysmenorrhea assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO)	12 months	No
Secondary	Satisfaction with the procedure	Overall satisfaction with the procedure via telephone survey (scaled from 0 to 9)	12 months	No
Secondary	Number of devices used	Number of coils and number of vascular plugs used in each procedure	intraoperative	No
Secondary	Cost of treatment	Cost of the differential devices used in each treatment procedure, assuming the same cost for the rest of the procedure, other material and hospital stay.	Intraoperative	No
Secondary	Total intervention duration	Total time length of the procedure, from puncture to compression (in minutes)	Intraoperative	No
Secondary	Fluoroscopy time	Total fluoroscopy time, recorded by the equipment (in minutes)	Intraoperative	Yes
Secondary	Procedure radiation dose (DAP)	DAP, dose area product of the intervention, (in mGy·cm2), recorded by fluoroscopy equipment	Intraoperative	Yes
Secondary	Procedure radiation dose (AK)	AK, total air kerma of the intervention (in Gy), recorded by fluoroscopy equipment	Intraoperative	Yes
Secondary	Complications	Overall complications of the procedure	intraoperative	Yes
Secondary	Complications	1 year overall complications related to procedure	12 months	Yes
Secondary	Need for re-embolization	Scheduled re-embolization due to incomplete occlusion	12 months	No