PMID- 37931844
OWN - NLM
STAT- MEDLINE
DCOM- 20240209
LR  - 20240213
IS  - 1535-7732 (Electronic)
IS  - 1051-0443 (Linking)
VI  - 35
IP  - 2
DP  - 2024 Feb
TI  - A First-in-Human Trial of a New Aqueous Ionic Liquid Embolic Material in Distal 
      Embolization Applications.
PG  - 232-240.e1
LID - S1051-0443(23)00797-2 [pii]
LID - 10.1016/j.jvir.2023.10.029 [doi]
AB  - PURPOSE: A prospective, single-arm, open-label, multicenter, first-in-human, 
      early feasibility study was completed to evaluate the safety and performance of 
      the GPX Embolic Device (Fluidx, Salt Lake City, Utah), a novel liquid embolic 
      agent, for use in the peripheral vasculature when deep distal embolization is 
      desired. MATERIALS AND METHODS: The early feasibility study evaluated the use of 
      the device in the peripheral vasculature. Enrollment consisted of 17 patients 
      with diverse embolization needs requiring deep distal vessel/vessel bed 
      occlusion. Technical success, freedom from adverse events (AEs), and 
      handling/performance characteristics were assessed with follow-up at 30 days. 
      RESULTS: The trial enrolled 17 patients requiring distal vascular penetration of 
      the embolic agent, including 7 with renal angiomyolipomas, 4 with renal cell 
      carcinomas (primary and secondary), 4 with portal veins needing embolization, 1 
      with pelvic sarcoma, and 1 with polycystic kidney. In all cases (100%), technical 
      success was achieved with target regions fully occluded on the first angiogram 
      (taken immediately after delivery). Furthermore, the material received high 
      usability ratings, as measured by a postprocedural investigator questionnaire. 
      Most patients (15/17, 88.2%) were free from device-related severe AEs, and there 
      were no unanticipated AEs during the study. Each patient completed a 30-day 
      follow-up evaluation, and sites remained fully occluded in each case where 
      imaging was available (6 [35.3%] of 17 patients had follow-up imaging where all 
      sites were deemed occluded [100%] with a mean of 30.2 days after the procedure). 
      CONCLUSIONS: The results of this first-in-human, early feasibility study 
      demonstrate that the GPX Embolic Device may provide safe and effective 
      embolization for arterial or venous applications where deep distal penetration is 
      desired.
CI  - Copyright (c) 2023 SIR. Published by Elsevier Inc. All rights reserved.
FAU - Holden, Andrew
AU  - Holden A
AD  - Auckland City Hospital, School of Medicine, University of Auckland, Auckland, New 
      Zealand. Electronic address: andrewh@adhb.govt.nz.
FAU - Krauss, Martin
AU  - Krauss M
AD  - Christchurch Hospital, University of Otago, Christchurch Central City, South 
      Island, New Zealand.
FAU - O'Hara, Ryan
AU  - O'Hara R
AD  - Comprehensive Integrated Care, Murray, Utah.
FAU - Jones, Joshua
AU  - Jones J
AD  - Fluidx Medical Technology, Salt Lake City, Utah.
FAU - Smith, Daniel K
AU  - Smith DK
AD  - Fluidx Medical Technology, Salt Lake City, Utah.
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
DEP - 20231104
PL  - United States
TA  - J Vasc Interv Radiol
JT  - Journal of vascular and interventional radiology : JVIR
JID - 9203369
RN  - 0 (Ionic Liquids)
SB  - IM
MH  - Humans
MH  - *Embolism
MH  - *Embolization, Therapeutic/adverse effects/methods
MH  - *Ionic Liquids
MH  - Prospective Studies
MH  - Treatment Outcome
EDAT- 2023/11/07 00:42
MHDA- 2024/01/29 06:42
CRDT- 2023/11/06 19:17
PHST- 2023/06/07 00:00 [received]
PHST- 2023/10/12 00:00 [revised]
PHST- 2023/10/19 00:00 [accepted]
PHST- 2024/01/29 06:42 [medline]
PHST- 2023/11/07 00:42 [pubmed]
PHST- 2023/11/06 19:17 [entrez]
AID - S1051-0443(23)00797-2 [pii]
AID - 10.1016/j.jvir.2023.10.029 [doi]
PST - ppublish
SO  - J Vasc Interv Radiol. 2024 Feb;35(2):232-240.e1. doi: 10.1016/j.jvir.2023.10.029. 
      Epub 2023 Nov 4.