WithdrawnPhase 1

Radiofrequency Ablation for Liver Abscesses From Chronic Granulomatous Disease

Stopped: PI choose to close the study

United States0Started 2013-05-08

Plain-language summary

Background: \- 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. Objectives: \- To see if RFA is a safe and effective treatment for CGD-related liver abscesses. Eligibility: \- Individuals between 18 and 75 years of age with CGD who have liver abscesses that cannot be treated with surgery. Design: * 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Has documented chronic granulomatous disease
. Age 18 - 75
. Has a liver abscess infected with Staphylococcus aureus or other microorganism susceptible to RFA, but is not an optimal candidate for curative surgical resection either due to location of disease, multiplicity of disease, or previous surgery or other comorbidities, such as pulmonary insufficiency, or has other contraindications to general anesthesia or perioperative management or refuses surgery.
. Is willing to return to NIH for imaging scans
. Is willing to undergo testing or procedures associated with this protocol
. Has failed long term antibiotic treatment and abscess drainage if applicable.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety of RFA in the treatment of liver abscesses in CGD subjects

Timeframe: Fater each patient completes the study

Trial details

NCT IDNCT01851460

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2020-03-24

View on ClinicalTrials.gov More Chronic Granulomatous Diseases (CGD) and Liver Lesions trials