NCT03169439

Brief Summary

Irreversible electroporation (IRE) is a novel non-thermal ablation modality with promise for revolutionizing the treatment for local solid tumors. With the growing demand for alternative and less invasive treatments for localized tumors, the investigators have seen the development and investigation of several tissue ablation modalities, including radiofrequency ablation (RFA), microwave ablation, and cryoablation. Although these modalities have been efficacious, they have some disadvantages owing to their reliance on thermal energy for creating cell death.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

1.8 years

First QC Date

May 25, 2017

Last Update Submit

May 26, 2017

Conditions

Oncology

Outcome Measures

Primary Outcomes (1)

  • The ablation success

    the ability to deliver planned therapy and to have no residual

    3 months

Secondary Outcomes (1)

  • Local recurrence

    3,6 and 12 months

Study Arms (1)

hepatic focal lesions and pancreatic masses

OTHER
Procedure: Irreversible electroporation

Interventions

Irreversible electroporationPROCEDURE

minimal invasive ablative technique for tumors

hepatic focal lesions and pancreatic masses

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with unresectable solid abdominal tumors (hepatic, pancreatic, porta hepatis,…).
  • The mass measures less than 4 cm.
  • Associated with no or oligo metastatic lesions

You may not qualify if:

  • Patients with cardiac arrhythmia and pacemaker.
  • Patients unfit for general anesthesia.
  • The lesion size is larger than 4 cm.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Davalos RV, Mir IL, Rubinsky B. Tissue ablation with irreversible electroporation. Ann Biomed Eng. 2005 Feb;33(2):223-31. doi: 10.1007/s10439-005-8981-8.

    PMID: 15771276BACKGROUND

  • Edd JF, Horowitz L, Davalos RV, Mir LM, Rubinsky B. In vivo results of a new focal tissue ablation technique: irreversible electroporation. IEEE Trans Biomed Eng. 2006 Jul;53(7):1409-15. doi: 10.1109/TBME.2006.873745.

    PMID: 16830945BACKGROUND

  • Lee EW, Chen C, Prieto VE, Dry SM, Loh CT, Kee ST. Advanced hepatic ablation technique for creating complete cell death: irreversible electroporation. Radiology. 2010 May;255(2):426-33. doi: 10.1148/radiol.10090337.

    PMID: 20413755BACKGROUND

  • Rubinsky B. Irreversible electroporation in medicine. Technol Cancer Res Treat. 2007 Aug;6(4):255-60. doi: 10.1177/153303460700600401.

    PMID: 17668932BACKGROUND

  • Kasivisvanathan V, Thapar A, Oskrochi Y, Picard J, Leen EL. Irreversible electroporation for focal ablation at the porta hepatis. Cardiovasc Intervent Radiol. 2012 Dec;35(6):1531-4. doi: 10.1007/s00270-012-0363-7. Epub 2012 Feb 25.

    PMID: 22367010BACKGROUND

  • Usman M, Moore W, Talati R, Watkins K, Bilfinger TV. Irreversible electroporation of lung neoplasm: a case series. Med Sci Monit. 2012 Jun;18(6):CS43-7. doi: 10.12659/msm.882888.

    PMID: 22648257BACKGROUND

  • Esser AT, Smith KC, Gowrishankar TR, Weaver JC. Towards solid tumor treatment by nanosecond pulsed electric fields. Technol Cancer Res Treat. 2009 Aug;8(4):289-306. doi: 10.1177/153303460900800406.

    PMID: 19645522BACKGROUND

  • Silk MT, Wimmer T, Lee KS, Srimathveeravalli G, Brown KT, Kingham PT, Fong Y, Durack JC, Sofocleous CT, Solomon SB. Percutaneous ablation of peribiliary tumors with irreversible electroporation. J Vasc Interv Radiol. 2014 Jan;25(1):112-8. doi: 10.1016/j.jvir.2013.10.012. Epub 2013 Nov 18.

    PMID: 24262034BACKGROUND

MeSH Terms

Conditions

Neoplasms

Interventions

Electroporation

Intervention Hierarchy (Ancestors)

Cytological TechniquesClinical Laboratory TechniquesInvestigative TechniquesElectrochemical Techniques

Central Study Contacts

Hosam Abozaid Yousef, MD

CONTACT

00201063602906hosameldeen68@gmail.com

Amr Farouk Murad, MD

CONTACT

00201061035700amrfarouk11@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

May 25, 2017

First Posted

May 30, 2017

Study Start

July 1, 2017

Primary Completion

April 1, 2019

Study Completion

August 1, 2019

Last Updated

May 30, 2017

Record last verified: 2017-05