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Multicenter randomized controlled trial and registry study to assess the safety and efficacy of the NanoKnife® system for the ablation of stage 3 pancreatic adenocarcinoma: overview of study protocols

Crossref DOI link: https://doi.org/10.1186/s12885-021-08474-4

Published Online: 2021-07-07

Published Print: 2021-12

Update policy: https://doi.org/10.1007/springer_crossmark_policy

Authors

Narayanan, Govindarajan

Bilimoria, Malcolm M.

Hosein, Peter J.

Su, Zhaohui

Mortimer, Kathleen M.

Martin, Robert C. G. II
Funding

Funding for this research was provided by:

AngioDynamics, Inc
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Article History

Received: 6 August 2020

Accepted: 9 June 2021

First Online: 7 July 2021

Declarations

:

: Both the randomized controlled trial and the registry study are being conducted following the Declaration of Helsinki and Ethical Guidelines for Medical and Health Research Involving Human Subjects and have been approved by the Western Institutional Review Board (20190961 and 20190965, respectively). All patients provided written informed consent before enrollment.

: Not Applicable.

: AngioDynamics (Latham, New York) provided funding to OMI1 for the power analyses and the development of the statistical analysis plan presented in the present paper. ZS and KM are employees of OM1, Inc. RCGM is a paid educational consultant to AngioDynamics. GN, MMB, and PJH have received consulting fees from AngioDynamics and their institutions are receiving research support from AngioDynamics for the ongoing studies described in the present work.

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