Liver AblationDUALNCT07900984
A Retrospective Registry of Intelliblate DUAL Channel Microwave Ablation
An observational study of Liver Ablation and Liver Cancer, run by Varian, a Siemens Healthineers Company.
Trial summary
This study reviews past patient records from multiple hospitals to learn how safe and effective the IntelliBlate Microwave Ablation System is when used to treat liver tumors with two probes at the same time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Ablation, Liver Cancer, Liver Cancer (Primary and Metastatic)
- What is being tested?
- Intelliblate Microwave Ablation (MWA) System
- Type of treatment
- Medical device
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will have undergone at least one dual channel MWA treatment in the liver using the Intellblate MWA system and have at least 30 days of follow-up for safety and 8 weeks (-4 weeks, +8 weeks) follow-up for complete ablation evaluation
Who may be able to join
- Undergone at least one MWA treatment in the liver using dual channel ablation on the Intelliblate MWA system.
- At least 30 days of follow-up post treatment for safety and 8 weeks (-4 weeks, +8 weeks) follow-up for imaging to assess complete ablation.
Who cannot join
- Undergone radioembolization or other radiotherapy to the liver.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study reviews past patient records from multiple hospitals to learn how safe and effective the IntelliBlate Microwave Ablation System is when used to treat liver tumors with two probes at the same time.
Read the detailed description
This study is a retrospective multi-center registry designed to evaluate the safety and performance of the Intelliblate Microwave Ablation (MWA) System with dual channel simultaneous microwave ablation of the liver.
- Being tested
- Intelliblate Microwave Ablation (MWA) System
- Keywords
- retrospective registry, liver ablation, intelliblate, dual channel microwave ablation
- Medical subject headings
- Liver Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intelliblate Microwave Ablation (MWA) SystemDevice
Subjects will have undergone at least one dual channel MWA treatment in the liver using the Intellblate MWA system
What is being measured
The primary outcome is the main question the study is designed to answer.
30-Day Major Complication Rate
30-day post-treatment Major Complication Rate (Grade 3 or above) according to CTCAE criteria. This evaluates the safety of the IntelliBlate MWA System using dual-channel simultaneous microwave ablation of the liver.
Measured: Treatment to 30 days of follow-up
Secondary outcomes (1)
Complete Ablation Rate
Complete Ablation Rate based on post-procedure imaging. This evaluates the performance/effectiveness of the IntelliBlate MWA System.
Measured: 8 weeks post-treatment, with an allowable window of -4 weeks to +8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Liver AblationStudies of the same condition, open and under way.
- More trials run by Varian, a Siemens Healthineers CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Varian, a Siemens Healthineers Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ashley Keefe, Study director, Varian, a Siemens Healthineers Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07900984
- Sponsor's protocol ID
- VAR-2026-01
- Acronym
- DUAL
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Individual participant data could be shared with each site for their own patients upon request.
Publications
Laeseke P, Ng C, Ferko N, Naghi A, Wright GWJ, Zhang Y, Laidlaw A, Kalsekar I, Laxmanan B, Ghosh SK, Zhou M, Szapary P, Pritchett M. Stereotactic body radiation therapy and thermal ablation for treatment of NSCLC: A systematic literature review and meta-analysis. Lung Cancer. 2023 Aug;182:107259. doi: 10.1016/j.lungcan.2023.107259. Epub 2023 Jun 2.
PubMed 37321074McClure T, Lansing A, Ferko N, Wright G, Ghosh SK, Raza S, Kalsekar I, Clarke K, Talenfeld A. A Comparison of Microwave Ablation and Cryoablation for the Treatment of Renal Cell Carcinoma: A Systematic Literature Review and Meta-analysis. Urology. 2023 Oct;180:1-8. doi: 10.1016/j.urology.2023.06.001. Epub 2023 Jun 17.
PubMed 37331485Cheng PL, Wu PH, Kao WY, Lai YT, Hsu JC, Chiou JF, Wu MH, Lee HL. Comparison of local ablative therapies, including radiofrequency ablation, microwave ablation, stereotactic ablative radiotherapy, and particle radiotherapy, for inoperable hepatocellular carcinoma: a systematic review and meta-analysis. Exp Hematol Oncol. 2023 Apr 12;12(1):37. doi: 10.1186/s40164-023-00400-7.
PubMed 37046292Zhang L, Du F, Zhang Y, Yangdan C, Wang H, Ren L. Microwave ablation is superior to radiofrequency ablation in the treatment of hepatocellular carcinoma below 5 cm - A systematic review and meta-analysis. J Minim Access Surg. 2023 Oct-Dec;19(4):453-458. doi: 10.4103/jmas.jmas_344_22.
PubMed 37706417Dou Z, Lu F, Ren L, Song X, Li B, Li X. Efficacy and safety of microwave ablation and radiofrequency ablation in the treatment of hepatocellular carcinoma: A systematic review and meta-analysis. Medicine (Baltimore). 2022 Jul 29;101(30):e29321. doi: 10.1097/MD.0000000000029321.
PubMed 35905207Pfannenstiel A, Iannuccilli J, Cornelis FH, Dupuy DE, Beard WL, Prakash P. Shaping the future of microwave tumor ablation: a new direction in precision and control of device performance. Int J Hyperthermia. 2022;39(1):664-674. doi: 10.1080/02656736.2021.1991012.
PubMed 35465811Hinshaw JL, Lubner MG, Ziemlewicz TJ, Lee FT Jr, Brace CL. Percutaneous tumor ablation tools: microwave, radiofrequency, or cryoablation--what should you use and why? Radiographics. 2014 Sep-Oct;34(5):1344-62. doi: 10.1148/rg.345140054.
PubMed 25208284Granata V, Grassi R, Fusco R, Setola SV, Palaia R, Belli A, Miele V, Brunese L, Grassi R, Petrillo A, Izzo F. Assessment of Ablation Therapy in Pancreatic Cancer: The Radiologist's Challenge. Front Oncol. 2020 Nov 27;10:560952. doi: 10.3389/fonc.2020.560952. eCollection 2020.
PubMed 33330028Glassberg MB, Ghosh S, Clymer JW, Qadeer RA, Ferko NC, Sadeghirad B, Wright GW, Amaral JF. Microwave ablation compared with radiofrequency ablation for treatment of hepatocellular carcinoma and liver metastases: a systematic review and meta-analysis. Onco Targets Ther. 2019 Aug 13;12:6407-6438. doi: 10.2147/OTT.S204340. eCollection 2019.
PubMed 31496742Simon CJ, Dupuy DE, Mayo-Smith WW. Microwave ablation: principles and applications. Radiographics. 2005 Oct;25 Suppl 1:S69-83. doi: 10.1148/rg.25si055501.
PubMed 16227498Ahmed M, Brace CL, Lee FT Jr, Goldberg SN. Principles of and advances in percutaneous ablation. Radiology. 2011 Feb;258(2):351-69. doi: 10.1148/radiol.10081634.
PubMed 21273519Livraghi T, Solbiati L, Meloni MF, Gazelle GS, Halpern EF, Goldberg SN. Treatment of focal liver tumors with percutaneous radio-frequency ablation: complications encountered in a multicenter study. Radiology. 2003 Feb;226(2):441-51. doi: 10.1148/radiol.2262012198.
PubMed 12563138Dupuy DE, DiPetrillo T, Gandhi S, Ready N, Ng T, Donat W, Mayo-Smith WW. Radiofrequency ablation followed by conventional radiotherapy for medically inoperable stage I non-small cell lung cancer. Chest. 2006 Mar;129(3):738-45. doi: 10.1378/chest.129.3.738.
PubMed 16537876
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Registry of Intelliblate DUAL Channel Microwave Ablation
- ClinicalTrials.gov ID
- NCT07900984
- Acronym / sponsor ID
- DUAL / VAR-2026-01
- Keywords
- retrospective registry, liver ablation, intelliblate, dual channel microwave ablation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Varian, a Siemens Healthineers CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study reviews past patient records from multiple hospitals to learn how safe and effective the IntelliBlate Microwave Ablation System is when used to treat liver tumors with two probes at the same time.
Detailed description
This study is a retrospective multi-center registry designed to evaluate the safety and performance of the Intelliblate Microwave Ablation (MWA) System with dual channel simultaneous microwave ablation of the liver.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will have undergone at least one dual channel MWA treatment in the liver using the Intellblate MWA system and have at least 30 days of follow-up for safety and 8 weeks (-4 weeks, +8 weeks) follow-up for complete ablation evaluation
Key inclusion criteria (2 listed)
- Undergone at least one MWA treatment in the liver using dual channel ablation on the Intelliblate MWA system.
- At least 30 days of follow-up post treatment for safety and 8 weeks (-4 weeks, +8 weeks) follow-up for imaging to assess complete ablation.
Key exclusion criteria (1 listed)
- Undergone radioembolization or other radiotherapy to the liver.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intelliblate Microwave Ablation (MWA) SystemSubjects will have undergone at least one dual channel MWA treatment in the liver using the Intellblate MWA system | Device | – |
Primary outcome
30-Day Major Complication Rate
Time frame: Treatment to 30 days of follow-up
30-day post-treatment Major Complication Rate (Grade 3 or above) according to CTCAE criteria. This evaluates the safety of the IntelliBlate MWA System using dual-channel simultaneous microwave ablation of the liver.
1 secondary outcome
Complete Ablation Rate
Time frame: 8 weeks post-treatment, with an allowable window of -4 weeks to +8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Background: PubMed 37321074Laeseke P, Ng C, Ferko N, Naghi A, Wright GWJ, Zhang Y, Laidlaw A, Kalsekar I, Laxmanan B, Ghosh SK, Zhou M, Szapary P, Pritchett M. Stereotactic body radiation therapy and thermal ablation for treatment of NSCLC: A systematic literature review and meta-analysis. Lung Cancer. 2023 Aug;182:107259. doi: 10.1016/j.lungcan.2023.107259. Epub 2023 Jun 2.
- Background: PubMed 37331485McClure T, Lansing A, Ferko N, Wright G, Ghosh SK, Raza S, Kalsekar I, Clarke K, Talenfeld A. A Comparison of Microwave Ablation and Cryoablation for the Treatment of Renal Cell Carcinoma: A Systematic Literature Review and Meta-analysis. Urology. 2023 Oct;180:1-8. doi: 10.1016/j.urology.2023.06.001. Epub 2023 Jun 17.
- Background: PubMed 37046292Cheng PL, Wu PH, Kao WY, Lai YT, Hsu JC, Chiou JF, Wu MH, Lee HL. Comparison of local ablative therapies, including radiofrequency ablation, microwave ablation, stereotactic ablative radiotherapy, and particle radiotherapy, for inoperable hepatocellular carcinoma: a systematic review and meta-analysis. Exp Hematol Oncol. 2023 Apr 12;12(1):37. doi: 10.1186/s40164-023-00400-7.
- Background: PubMed 37706417Zhang L, Du F, Zhang Y, Yangdan C, Wang H, Ren L. Microwave ablation is superior to radiofrequency ablation in the treatment of hepatocellular carcinoma below 5 cm - A systematic review and meta-analysis. J Minim Access Surg. 2023 Oct-Dec;19(4):453-458. doi: 10.4103/jmas.jmas_344_22.
- Background: PubMed 35905207Dou Z, Lu F, Ren L, Song X, Li B, Li X. Efficacy and safety of microwave ablation and radiofrequency ablation in the treatment of hepatocellular carcinoma: A systematic review and meta-analysis. Medicine (Baltimore). 2022 Jul 29;101(30):e29321. doi: 10.1097/MD.0000000000029321.
- Background: PubMed 35465811Pfannenstiel A, Iannuccilli J, Cornelis FH, Dupuy DE, Beard WL, Prakash P. Shaping the future of microwave tumor ablation: a new direction in precision and control of device performance. Int J Hyperthermia. 2022;39(1):664-674. doi: 10.1080/02656736.2021.1991012.
- Background: PubMed 25208284Hinshaw JL, Lubner MG, Ziemlewicz TJ, Lee FT Jr, Brace CL. Percutaneous tumor ablation tools: microwave, radiofrequency, or cryoablation--what should you use and why? Radiographics. 2014 Sep-Oct;34(5):1344-62. doi: 10.1148/rg.345140054.
- Background: PubMed 33330028Granata V, Grassi R, Fusco R, Setola SV, Palaia R, Belli A, Miele V, Brunese L, Grassi R, Petrillo A, Izzo F. Assessment of Ablation Therapy in Pancreatic Cancer: The Radiologist's Challenge. Front Oncol. 2020 Nov 27;10:560952. doi: 10.3389/fonc.2020.560952. eCollection 2020.
- Background: PubMed 31496742Glassberg MB, Ghosh S, Clymer JW, Qadeer RA, Ferko NC, Sadeghirad B, Wright GW, Amaral JF. Microwave ablation compared with radiofrequency ablation for treatment of hepatocellular carcinoma and liver metastases: a systematic review and meta-analysis. Onco Targets Ther. 2019 Aug 13;12:6407-6438. doi: 10.2147/OTT.S204340. eCollection 2019.
- Background: PubMed 16227498Simon CJ, Dupuy DE, Mayo-Smith WW. Microwave ablation: principles and applications. Radiographics. 2005 Oct;25 Suppl 1:S69-83. doi: 10.1148/rg.25si055501.
- Background: PubMed 21273519Ahmed M, Brace CL, Lee FT Jr, Goldberg SN. Principles of and advances in percutaneous ablation. Radiology. 2011 Feb;258(2):351-69. doi: 10.1148/radiol.10081634.
- Background: PubMed 12563138Livraghi T, Solbiati L, Meloni MF, Gazelle GS, Halpern EF, Goldberg SN. Treatment of focal liver tumors with percutaneous radio-frequency ablation: complications encountered in a multicenter study. Radiology. 2003 Feb;226(2):441-51. doi: 10.1148/radiol.2262012198.
- Individual participant dataSharing planned: Undecided. Individual participant data could be shared with each site for their own patients upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ashley Keefe study director
Varian, a Siemens Healthineers Company
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Ablation and Liver Cancer, run by Varian, a Siemens Healthineers Company.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Manager (5102799833, febasusan.sam@siemens-healthineers.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-Day Major Complication Rate (time frame: Treatment to 30 days of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07900984, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.