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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02310165
Other study ID # 16842
Secondary ID
Status Completed
Phase N/A
First received December 3, 2014
Last updated December 3, 2014
Start date July 2013
Est. completion date June 2014

Study information

Verified date December 2014
Source University of Virginia
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare two different methods that are used for inserting the needle during paracentesis. One method is called the "coaxial insertion technique" and the other is called the "z-tract technique". Researchers would like to see which method is better and leads to less problems like oozing from the needle insertion site and pain during the procedure. Both methods are approved and currently used methods for doing a paracentesis at the University of Virginia. Which method is used generally depends on physician preference. There have been no studies done to date that compare these two methods for needle insertion.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age 18 years and older

- Agreement to participate

- Patients with cirrhosis (confirmed by liver biopsy or clinically diagnosed) and ascites

- Patients presenting to UVA Digestive Health Clinic for a scheduled therapeutic paracentesis who do not have any contraindications to the procedure

- Ability to be reliably contacted by phone 24 hours following paracentesis

Exclusion Criteria:

- Prisoners

- Non-english speaking

- Paracentesis with less than 5 liters of ascitic fluid removed. (If this occurs, the specific subject encounter will be removed from the study but the subject may be included if at their next regularly scheduled paracentesis 5 liters or greater of ascitic fluid is removed.)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Z-tract Insertion Technique

Coaxial Insertion Technique


Locations

Country Name City State
United States University of Virginia Charlottesville Virginia

Sponsors (1)

Lead Sponsor Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Post procedural leaking at the needle insertion site 24 hours Yes
Secondary Patient reported procedural pain Immediately following paracentesis No
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