Prospective Analysis of In Vivo Laparoscopic Microwave Ablation Thermodynamics

NCT05471596 | Completed FDA Device

• 2 other identifiers: IRB0008268302-22-19E
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Liver Diseases

Keywords

Liver Cancer; Liver Lesion; Microwave Ablation; NeuWave Surgical; Hepatobiliarypancreato Surgery; Hepato-Pancreato-Biliary (HPB) Surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  Year 2

Secondary Outcomes (23)

• Liver appearance

  Baseline

• Presence of extrahepatic disease

  Baseline

• Chronic Liver Disease Evidence

  Baseline

• Number of Lesions

  Baseline

• Lesion location

  Baseline

Study Arms (1)

NeuWave Microwave Ablation System

Patients who underwent a Microwave Ablation at a participating institution and a NeuWave generator was utilized.

Device: NeuWave Microwave Ablation System

Interventions

NeuWave Microwave Ablation System DEVICE

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.

NeuWave Microwave Ablation System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults (Age \>18 years old) with hepatic lesion(s) treated by microwave ablation

You may qualify if:

• Adults with hepatic tumors (Age \>18 years or older)
• Treatment included microwave ablation with the Neuwave system

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Johnson & Johnson: collaborator

Study Sites (1)

Atrium Health

Charlotte, North Carolina, 28203, United States

Location

Related Publications (17)

• 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.

  PMID: 20140536 BACKGROUND

• Groeschl 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.

  PMID: 24096760 BACKGROUND

• Swan 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.

  PMID: 23404173 BACKGROUND

• Bhardwaj 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.

  PMID: 19880269 BACKGROUND

• Iannitti 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.

  PMID: 18333126 BACKGROUND

• Martin 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.

  PMID: 19707829 BACKGROUND

• Liang 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.

  PMID: 19304921 BACKGROUND

• Livraghi 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.

  PMID: 21833809 BACKGROUND

• Laeseke 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.

  PMID: 21857888 BACKGROUND

• Harari 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.

  PMID: 26133361 BACKGROUND

• Knavel 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.

  PMID: 22358023 BACKGROUND

• Poulou 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.

  PMID: 26052394 BACKGROUND

• Al-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.

  PMID: 27566426 BACKGROUND

• Deshazer 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.

  PMID: 27036574 BACKGROUND

• Liu 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.

  PMID: 28151729 BACKGROUND

• Hubner F, Schreiner R, Reimann C, Bazrafshan B, Kaltenbach B, Schussler M, Jakoby R, Vogl TJ. Ex vivo validation of microwave thermal ablation simulation using different flow coefficients in the porcine liver. Med Eng Phys. 2019 Apr;66:56-64. doi: 10.1016/j.medengphy.2019.02.007. Epub 2019 Feb 28.

  PMID: 30826254 BACKGROUND

• Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.

  PMID: 19638912 BACKGROUND

MeSH Terms

Conditions

Liver Diseases; Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Diseases; Digestive System Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• David A Iannitti, MD

  Physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: July 25, 2022
• Study Start: February 14, 2022
• Primary Completion: November 17, 2023
• Study Completion: November 17, 2023
• Last Updated: March 4, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)