Liver DiseasesMWANCT05471596
Prospective Analysis of In Vivo Laparoscopic Microwave Ablation Thermodynamics
An observational study of Liver Diseases, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
To prospectively collect and evaluate pre-operative, intra-operative, and post-operative variables for all patients undergoing surgical microwave ablation. All patients who have a surgical microwave ablation with the Neuwave system will be added to the database after their treatment and procedures have been completed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Diseases
- What is being tested?
- NeuWave Microwave Ablation System
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2022to 17 Nov 2023
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Adults (Age >18 years old) with hepatic lesion(s) treated by microwave ablation
Who may be able to join
- Adults with hepatic tumors (Age >18 years or older)
- Treatment included microwave ablation with the Neuwave system
Who cannot join
- Age <18
- Benign Tumors
- Patients whose initial treatment plan did not include MWA, although they later received one (rescue MWA)
- Multiple tumors with distances or geometric relations rendering volumetrics incalculable or unduly confounded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Analysis of In Vivo Laparoscopic Microwave Ablation Thermodynamics in Hepato-Pancreato-Biliary Solid Tumors
To prospectively collect and evaluate pre-operative, intra-operative, and post-operative variables for all patients undergoing surgical microwave ablation. All patients who have a surgical microwave ablation with the Neuwave system will be added to the database after their treatment and procedures have been completed.
Read the detailed description
To prospectively collect and evaluate pre-operative, intra-operative, and post-operative variables for all patients undergoing surgical microwave ablation. All patients who have a surgical microwave ablation with the Neuwave system will be added to the database after their treatment and procedures have been completed. All data points will be collected from the electronic medical records (EMR) (office visit notes, operative notes, follow-up visits, CT scans, etc.). The collected data points will be utilized to study outcomes such as local/regional reoccurrences and distant occurrences related to hepatic tumor(s), whether there was complete destruction, residual disease/incomplete destruction, or recurrence at the ablation site. Overall-complications, length of stay, readmission rates, and any additional outcomes data that is relevant to MWA and improving surgical outcomes will also be collected.
There are various Microwave Ablation (MWA) systems available that are utilized at the study locations to treat hepatic tumors. For this study, the focus is on subjects treated with the Certus 140TM system from NeuWave Medical®. Certus 140TM microwave generator possesses a 2.45 gigahertz (GHz) operating frequency and can power up to 140 watts. It can deliver microwave energy through three distinct channels simultaneously through a single system and uses three distinct antenna types (LK, SR, PR). It also contains a CO2-based cooling system that helps limit the temperature of the handle and cable. It is compatible with a variety of probes (LK, SR and PR antenna) and offers two modes, Ablation mode and Surgical mode. The Ablation mode is used for ablating a substantial target for several minutes until the object of the ablation is necrotic. Surgical Mode is used to ablate or coagulate a target for shorter periods of time while frequently moving the probe in a technique known as "planar coagulation."
Current data and manufacturer guidelines for recommended ablation energy outputs for microwave ablation systems are obtained via ex vivo and animal models with tissues that exhibit different properties of energy transference than in vivo human tissues, particularly, human hepatic solid tumors. The objective is to prospectively assess the thermodynamics of microwave ablation energy in this context, specifically through the creation of power/time curves to predict future ablation volumes through single applications of MWA energy per lesion.
- Conditions
- Liver Diseases
- Being tested
- NeuWave Microwave Ablation System
- Keywords
- Liver Cancer, Liver Lesion, Microwave Ablation, NeuWave Surgical, Hepatobiliarypancreato Surgery, Hepato-Pancreato-Biliary (HPB) Surgery
- Medical subject headings
- Liver Diseases, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuWave Microwave Ablation SystemDevice
The NEUWAVE System supports target ablation or linear coagulation in surgical liver resection procedures. The System offers a versatile probe portfolio, multi-probe synchrony and CO2 cooling to help control the shape, size and burn pattern of your ablations.
| Study group | Role | What they receive |
|---|---|---|
| NeuWave Microwave Ablation System | Patients who underwent a Microwave Ablation at a participating institution and a NeuWave generator was utilized. Receives: Device: NeuWave Microwave Ablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prospective Power/Time Analysis of In Vivo Laparoscopic Microwave Ablation Thermodynamics in Hepato-Pancreato-Biliary Sold Tumors Utilizing a Single Generator at a Single Surgical Center
The primary objective is to prospectively assess the thermodynamics of microwave ablation energy in this context, specifically through the creation of power/time curves to predict future ablation volumes through single applications of MWA energy per lesion.
Measured: Year 2
Secondary outcomes (23)
Liver appearance
Investigator to describe the appearance of the liver intraoperatively
Measured: Baseline
Presence of extrahepatic disease
Investigator to describe if any extrahepatic disease is present
Measured: Baseline
Chronic Liver Disease Evidence
Investigator to describe if any chronic liver disease is present
Measured: Baseline
Number of Lesions
Number of lesions present
Measured: Baseline
Lesion location
Location (segment) of each lesion
Measured: Baseline
Size of Lesion
Size of each lesion
Measured: Baseline
Amount of Power used
Power (W) used to ablate each lesion
Measured: Baseline
Amount of Time used
Time (min) used to ablate each lesion
Measured: Baseline
Distance between lesions
The distance between liver lesions
Measured: Baseline
Ablation Dimensions
Ablation dimensions as assessed by post-operative cross-sectional imaging using the x-axis along the length of the antenna tract and y-axis perpendicular to the antenna tract
Measured: day 90
Disease Recurrence Rate
Disease recurrence defined as the radiologic presence of disease present at the index location at the 4-week follow up postoperative cross-sectional imaging
Measured: week 4
Number of New lesions
New lesions noted on CT (as above) and their measurements
Measured: day 90
Radiographic liver appearance
Liver appearance on CT
Measured: day 90
Radiographic extrahepatic disease
Presence of extrahepatic disease on CT
Measured: day 90
Tumor measurement
Index tumor diameter and volume
Measured: Baseline
Ablation Time
The time at which ablation occurred
Measured: Baseline
Ablation Energy output
Energy output from ablation
Measured: Baseline
Ablation Margins
Ablation margins
Measured: day 90
Operative Time Amount
Time from first incision until final skin closure
Measured: Baseline
Length of Stay
Time from hospital admission until hospital discharge
Measured: up to 90 days
Readmission Rates
Percentage of patients who were readmitted to the hospital after MWA
Measured: day 90
30 day complication rate
Percentage of patients who experienced a complication 30 following MWA
Measured: day 30
90 day complication rate
Percentage of patients who experienced a complication 90 following MWA
Measured: day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start14 Feb 2022
- Primary completion17 Nov 2023
- Study completion17 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
- Responsible party
- Sponsor
- Investigators
- David A Iannitti, MD, Principal investigator, Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05471596
- Sponsor's protocol ID
- IRB00082683
- Other IDs
- 02-22-19E
- Acronym
- MWA
- Status last verified
- Feb 2024
- First submitted
- 20 Jul 2022
- Last updated
- 4 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Mathur AK, Ghaferi AA, Sell K, Sonnenday CJ, Englesbe MJ, Welling TH. Influence of body mass index on complications and oncologic outcomes following hepatectomy for malignancy. J Gastrointest Surg. 2010 May;14(5):849-57. doi: 10.1007/s11605-010-1163-5. Epub 2010 Feb 6.
PubMed 20140536Groeschl RT, Pilgrim CH, Hanna EM, Simo KA, Swan RZ, Sindram D, Martinie JB, Iannitti DA, Bloomston M, Schmidt C, Khabiri H, Shirley LA, Martin RC, Tsai S, Turaga KK, Christians KK, Rilling WS, Gamblin TC. Microwave ablation for hepatic malignancies: a multiinstitutional analysis. Ann Surg. 2014 Jun;259(6):1195-200. doi: 10.1097/SLA.0000000000000234.
PubMed 24096760Swan RZ, Sindram D, Martinie JB, Iannitti DA. Operative microwave ablation for hepatocellular carcinoma: complications, recurrence, and long-term outcomes. J Gastrointest Surg. 2013 Apr;17(4):719-29. doi: 10.1007/s11605-013-2164-y. Epub 2013 Feb 13.
PubMed 23404173Bhardwaj N, Strickland AD, Ahmad F, El-Abassy M, Morgan B, Robertson GS, Lloyd DM. Microwave ablation for unresectable hepatic tumours: clinical results using a novel microwave probe and generator. Eur J Surg Oncol. 2010 Mar;36(3):264-8. doi: 10.1016/j.ejso.2009.10.006. Epub 2009 Oct 31.
PubMed 19880269Iannitti DA, Martin RC, Simon CJ, Hope WW, Newcomb WL, McMasters KM, Dupuy D. Hepatic tumor ablation with clustered microwave antennae: the US Phase II trial. HPB (Oxford). 2007;9(2):120-4. doi: 10.1080/13651820701222677.
PubMed 18333126Martin RC, Scoggins CR, McMasters KM. Safety and efficacy of microwave ablation of hepatic tumors: a prospective review of a 5-year experience. Ann Surg Oncol. 2010 Jan;17(1):171-8. doi: 10.1245/s10434-009-0686-z. Epub 2009 Aug 26.
PubMed 19707829Liang P, Wang Y, Yu X, Dong B. Malignant liver tumors: treatment with percutaneous microwave ablation--complications among cohort of 1136 patients. Radiology. 2009 Jun;251(3):933-40. doi: 10.1148/radiol.2513081740. Epub 2009 Mar 20.
PubMed 19304921Livraghi T, Meloni F, Solbiati L, Zanus G; Collaborative Italian Group using AMICA system. Complications of microwave ablation for liver tumors: results of a multicenter study. Cardiovasc Intervent Radiol. 2012 Aug;35(4):868-74. doi: 10.1007/s00270-011-0241-8. Epub 2011 Aug 11.
PubMed 21833809Laeseke PF, Lee FT Jr, van der Weide DW, Brace CL. Multiple-Antenna Microwave Ablation: Spatially Distributing Power Improves Thermal Profiles and Reduces Invasiveness. J Interv Oncol. 2009;2(2):65-72.
PubMed 21857888Harari CM, Magagna M, Bedoya M, Lee FT Jr, Lubner MG, Hinshaw JL, Ziemlewicz T, Brace CL. Microwave Ablation: Comparison of Simultaneous and Sequential Activation of Multiple Antennas in Liver Model Systems. Radiology. 2016 Jan;278(1):95-103. doi: 10.1148/radiol.2015142151. Epub 2015 Jul 2.
PubMed 26133361Knavel EM, Hinshaw JL, Lubner MG, Andreano A, Warner TF, Lee FT Jr, Brace CL. High-powered gas-cooled microwave ablation: shaft cooling creates an effective stick function without altering the ablation zone. AJR Am J Roentgenol. 2012 Mar;198(3):W260-5. doi: 10.2214/AJR.11.6503.
PubMed 22358023Poulou LS, Botsa E, Thanou I, Ziakas PD, Thanos L. Percutaneous microwave ablation vs radiofrequency ablation in the treatment of hepatocellular carcinoma. World J Hepatol. 2015 May 18;7(8):1054-63. doi: 10.4254/wjh.v7.i8.1054.
PubMed 26052394Al-Hakim RA, Abtin FG, Genshaft SJ, Kutay E, Suh RD. Defining New Metrics in Microwave Ablation of Pulmonary Tumors: Ablation Work and Ablation Resistance Score. J Vasc Interv Radiol. 2016 Sep;27(9):1380-1386. doi: 10.1016/j.jvir.2016.05.026.
PubMed 27566426Deshazer G, Merck D, Hagmann M, Dupuy DE, Prakash P. Physical modeling of microwave ablation zone clinical margin variance. Med Phys. 2016 Apr;43(4):1764. doi: 10.1118/1.4942980.
PubMed 27036574Liu D, Brace CL. Numerical simulation of microwave ablation incorporating tissue contraction based on thermal dose. Phys Med Biol. 2017 Mar 21;62(6):2070-2086. doi: 10.1088/1361-6560/aa5de4. Epub 2017 Feb 2.
PubMed 28151729
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Analysis of In Vivo Laparoscopic Microwave Ablation Thermodynamics in Hepato-Pancreato-Biliary Solid Tumors
- ClinicalTrials.gov ID
- NCT05471596
- Acronym / sponsor ID
- MWA / IRB00082683
- Conditions
- Liver Diseases
- Keywords
- Liver Cancer, Liver Lesion, Microwave Ablation, NeuWave Surgical, Hepatobiliarypancreato Surgery, Hepato-Pancreato-Biliary (HPB) Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Johnson & Johnson
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 17 Nov 2023 (actual)
- Study completion
- 17 Nov 2023 (actual)
- First posted
- 25 Jul 2022 (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.
To prospectively collect and evaluate pre-operative, intra-operative, and post-operative variables for all patients undergoing surgical microwave ablation. All patients who have a surgical microwave ablation with the Neuwave system will be added to the database after their treatment and procedures have been completed.
Detailed description
To prospectively collect and evaluate pre-operative, intra-operative, and post-operative variables for all patients undergoing surgical microwave ablation. All patients who have a surgical microwave ablation with the Neuwave system will be added to the database after their treatment and procedures have been completed. All data points will be collected from the electronic medical records (EMR) (office visit notes, operative notes, follow-up visits, CT scans, etc.). The collected data points will be utilized to study outcomes such as local/regional reoccurrences and distant occurrences related to hepatic tumor(s), whether there was complete destruction, residual disease/incomplete destruction, or recurrence at the ablation site. Overall-complications, length of stay, readmission rates, and any additional outcomes data that is relevant to MWA and improving surgical outcomes will also be collected.
There are various Microwave Ablation (MWA) systems available that are utilized at the study locations to treat hepatic tumors. For this study, the focus is on subjects treated with the Certus 140TM system from NeuWave Medical®. Certus 140TM microwave generator possesses a 2.45 gigahertz (GHz) operating frequency and can power up to 140 watts. It can deliver microwave energy through three distinct channels simultaneously through a single system and uses three distinct antenna types (LK, SR, PR). It also contains a CO2-based cooling system that helps limit the temperature of the handle and cable. It is compatible with a variety of probes (LK, SR and PR antenna) and offers two modes, Ablation mode and Surgical mode. The Ablation mode is used for ablating a substantial target for several minutes until the object of the ablation is necrotic. Surgical Mode is used to ablate or coagulate a target for shorter periods of time while frequently moving the probe in a technique known as "planar coagulation."
Current data and manufacturer guidelines for recommended ablation energy outputs for microwave ablation systems are obtained via ex vivo and animal models with tissues that exhibit different properties of energy transference than in vivo human tissues, particularly, human hepatic solid tumors. The objective is to prospectively assess the thermodynamics of microwave ablation energy in this context, specifically through the creation of power/time curves to predict future ablation volumes through single applications of MWA energy per lesion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NeuWave Microwave Ablation System | – | Device: NeuWave Microwave Ablation SystemPatients who underwent a Microwave Ablation at a participating institution and a NeuWave generator was utilized. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (Age >18 years old) with hepatic lesion(s) treated by microwave ablation
Key inclusion criteria (2 listed)
- Adults with hepatic tumors (Age >18 years or older)
- Treatment included microwave ablation with the Neuwave system
Key exclusion criteria (4 listed)
- Age <18
- Benign Tumors
- Patients whose initial treatment plan did not include MWA, although they later received one (rescue MWA)
- Multiple tumors with distances or geometric relations rendering volumetrics incalculable or unduly confounded
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 |
|---|---|---|
| NeuWave Microwave Ablation SystemThe NEUWAVE System supports target ablation or linear coagulation in surgical liver resection procedures. The System offers a versatile probe portfolio, multi-probe synchrony and CO2 cooling to help control the shape, size and burn pattern of your ablations. | Device | NeuWave Microwave Ablation System |
Primary outcome
Prospective Power/Time Analysis of In Vivo Laparoscopic Microwave Ablation Thermodynamics in Hepato-Pancreato-Biliary Sold Tumors Utilizing a Single Generator at a Single Surgical Center
Time frame: Year 2
The primary objective is to prospectively assess the thermodynamics of microwave ablation energy in this context, specifically through the creation of power/time curves to predict future ablation volumes through single applications of MWA energy per lesion.
23 secondary outcomes
Liver appearance
Time frame: Baseline
Presence of extrahepatic disease
Time frame: Baseline
Chronic Liver Disease Evidence
Time frame: Baseline
Number of Lesions
Time frame: Baseline
Lesion location
Time frame: Baseline
Size of Lesion
Time frame: Baseline
Amount of Power used
Time frame: Baseline
Amount of Time used
Time frame: Baseline
Distance between lesions
Time frame: Baseline
Ablation Dimensions
Time frame: day 90
Disease Recurrence Rate
Time frame: week 4
Number of New lesions
Time frame: day 90
Radiographic liver appearance
Time frame: day 90
Radiographic extrahepatic disease
Time frame: day 90
Tumor measurement
Time frame: Baseline
Ablation Time
Time frame: Baseline
Ablation Energy output
Time frame: Baseline
Ablation Margins
Time frame: day 90
Operative Time Amount
Time frame: Baseline
Length of Stay
Time frame: up to 90 days
Readmission Rates
Time frame: day 90
30 day complication rate
Time frame: day 30
90 day complication rate
Time frame: day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Background: PubMed 20140536Mathur AK, Ghaferi AA, Sell K, Sonnenday CJ, Englesbe MJ, Welling TH. Influence of body mass index on complications and oncologic outcomes following hepatectomy for malignancy. J Gastrointest Surg. 2010 May;14(5):849-57. doi: 10.1007/s11605-010-1163-5. Epub 2010 Feb 6.
- Background: PubMed 24096760Groeschl RT, Pilgrim CH, Hanna EM, Simo KA, Swan RZ, Sindram D, Martinie JB, Iannitti DA, Bloomston M, Schmidt C, Khabiri H, Shirley LA, Martin RC, Tsai S, Turaga KK, Christians KK, Rilling WS, Gamblin TC. Microwave ablation for hepatic malignancies: a multiinstitutional analysis. Ann Surg. 2014 Jun;259(6):1195-200. doi: 10.1097/SLA.0000000000000234.
- Background: PubMed 23404173Swan RZ, Sindram D, Martinie JB, Iannitti DA. Operative microwave ablation for hepatocellular carcinoma: complications, recurrence, and long-term outcomes. J Gastrointest Surg. 2013 Apr;17(4):719-29. doi: 10.1007/s11605-013-2164-y. Epub 2013 Feb 13.
- Background: PubMed 19880269Bhardwaj N, Strickland AD, Ahmad F, El-Abassy M, Morgan B, Robertson GS, Lloyd DM. Microwave ablation for unresectable hepatic tumours: clinical results using a novel microwave probe and generator. Eur J Surg Oncol. 2010 Mar;36(3):264-8. doi: 10.1016/j.ejso.2009.10.006. Epub 2009 Oct 31.
- Background: PubMed 18333126Iannitti DA, Martin RC, Simon CJ, Hope WW, Newcomb WL, McMasters KM, Dupuy D. Hepatic tumor ablation with clustered microwave antennae: the US Phase II trial. HPB (Oxford). 2007;9(2):120-4. doi: 10.1080/13651820701222677.
- Background: PubMed 19707829Martin RC, Scoggins CR, McMasters KM. Safety and efficacy of microwave ablation of hepatic tumors: a prospective review of a 5-year experience. Ann Surg Oncol. 2010 Jan;17(1):171-8. doi: 10.1245/s10434-009-0686-z. Epub 2009 Aug 26.
- Background: PubMed 19304921Liang P, Wang Y, Yu X, Dong B. Malignant liver tumors: treatment with percutaneous microwave ablation--complications among cohort of 1136 patients. Radiology. 2009 Jun;251(3):933-40. doi: 10.1148/radiol.2513081740. Epub 2009 Mar 20.
- Background: PubMed 21833809Livraghi T, Meloni F, Solbiati L, Zanus G; Collaborative Italian Group using AMICA system. Complications of microwave ablation for liver tumors: results of a multicenter study. Cardiovasc Intervent Radiol. 2012 Aug;35(4):868-74. doi: 10.1007/s00270-011-0241-8. Epub 2011 Aug 11.
- Background: PubMed 21857888Laeseke PF, Lee FT Jr, van der Weide DW, Brace CL. Multiple-Antenna Microwave Ablation: Spatially Distributing Power Improves Thermal Profiles and Reduces Invasiveness. J Interv Oncol. 2009;2(2):65-72.
- Background: PubMed 26133361Harari CM, Magagna M, Bedoya M, Lee FT Jr, Lubner MG, Hinshaw JL, Ziemlewicz T, Brace CL. Microwave Ablation: Comparison of Simultaneous and Sequential Activation of Multiple Antennas in Liver Model Systems. Radiology. 2016 Jan;278(1):95-103. doi: 10.1148/radiol.2015142151. Epub 2015 Jul 2.
- Background: PubMed 22358023Knavel EM, Hinshaw JL, Lubner MG, Andreano A, Warner TF, Lee FT Jr, Brace CL. High-powered gas-cooled microwave ablation: shaft cooling creates an effective stick function without altering the ablation zone. AJR Am J Roentgenol. 2012 Mar;198(3):W260-5. doi: 10.2214/AJR.11.6503.
- Background: PubMed 26052394Poulou LS, Botsa E, Thanou I, Ziakas PD, Thanos L. Percutaneous microwave ablation vs radiofrequency ablation in the treatment of hepatocellular carcinoma. World J Hepatol. 2015 May 18;7(8):1054-63. doi: 10.4254/wjh.v7.i8.1054.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
David A Iannitti, MD principal investigator
Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Diseases, run by Wake Forest University Health Sciences at 1 site in United States.
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 4 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: finished, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prospective Power/Time Analysis of In Vivo Laparoscopic Microwave Ablation Thermodynamics in Hepato-Pancreato-Biliary Sold Tumors Utilizing a Single Generator at a Single Surgical Center (time frame: Year 2). 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 NCT05471596, which also lists 17 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 4 Mar 2024.