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NCT01851460
Radiofrequency Ablation for Liver Abscesses From Chronic Granulomatous Disease
Phase 1 trial testing Cool-tip RF Ablation System in Chronic Granulomatous Diseases (CGD) and Liver Lesions. Withdrawn.
24 March 2020
Quick facts
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Phase | Phase 1 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Start date | 8 May 2013 |
| Primary completion | 24 March 2020 |
| Estimated completion | 24 March 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Cool-tip RF Ablation System
Conditions studied
- Chronic Granulomatous Diseases (CGD) and Liver Lesions — all drugs for Chronic Granulomatous Diseases (CGD) and Liver Lesions →
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Who can join
Adults 18 to 75, any sex, with Chronic Granulomatous Diseases (CGD) and Liver Lesions. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01851460 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID)
- Last refreshed: 26 March 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01851460.
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