Radiofrequency Ablation for Liver Abscesses From Chronic Granulomatous Disease
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|ClinicalTrials.gov Identifier: NCT01851460|
Recruitment Status : Recruiting
First Posted : May 10, 2013
Last Update Posted : August 15, 2018
- Abscesses are a pocket of infection in an organ or tissue. Patients with a disease called chronic granulomatous disease (CGD) often develop these abscesses. CGD is an inherited disorder that affects how white blood cells function. Liver abscesses in people with CGD often require surgery to remove them and treat the infection. However, some people with CGD cannot have full surgery because it would be too risky. Researchers want to try a procedure called radiofrequency ablation (RFA) to treat these liver abscesses. RFA can usually be done without a major operation. This study will see if RFA is a safe and effective treatment for liver abscesses in patients with CGD.
- To see if RFA is a safe and effective treatment for CGD-related liver abscesses.
- Individuals between 18 and 75 years of age with CGD who have liver abscesses that cannot be treated with surgery.
- Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Imaging studies will be performed on the liver.
- Participants will have RFA for the abscesses. RFA is an image-guided technique that heats and destroys specific tissue, such as tumor tissue. It will target any abscesses on the liver.
- After the procedure, participants will stay in the hospital for monitoring before being released.
- Participants will have regular follow-up visits for up to 1 year after treatment. Blood and urine samples will be collected. Additional imaging studies will be performed.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Granulomatous Disease (CGD)||Device: Cool-tip RF Ablation System||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Radiofrequency Ablation (RFA) for the Treatment of Liver Abscesses in Patients With Chronic Granulomatous Disease|
|Study Start Date :||May 8, 2013|
|Estimated Primary Completion Date :||January 1, 2020|
|Estimated Study Completion Date :||January 1, 2021|
All subjects enrolled onto this study will receive treatment of their liver abscess (es) by RFA ablation
Device: Cool-tip RF Ablation System
RFA therapy will be administered according to the instructions of the RFA device manufacturer.
- The primary objective of this study is to determine the safety ofradiofrequency ablation (RFA) in the treatment of liver abscesses insubjects with chronic granulomatous disease (CGD). [ Time Frame: Throughout ]
- To determine if RFA is a reasonable treatment option for patients with liver abscesses who are not suitable candidates for completely curative hepatic surgery [ Time Frame: Throughout ]
- To compare the recovery outcomes of patients undergoing RFA versus historical controls for patients undergoing surgery for treatment of liver abscesses [ Time Frame: Throughout ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01851460
|Contact: Patricia L Littel, R.N.||(301) firstname.lastname@example.org|
|Contact: Elizabeth M Kang, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Elizabeth M Kang, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|