Technologische Zusammenfassung
FULL SPECTRUM ENDOSCOPY®
FUSE®
Fuse® and Full Spectrum Endoscopy® are registered trademarks of EndoChoice Inc.
Technologie
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Ein Fortschritt in der GI-Bildgebung
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1C Koloskop 330° Sichtfeld
C38s Slim Koloskop 330° Sichtfeld
Technik
Linse
LED LED
Luft/Wasser
Düse
LED
3.8mm Arbeitskanal
Linse
LED LED
Luft/Wasser
Düse
Wasserstrahl
vorwärts
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(170°) Eingeschränkte Sicht mit herkömmlichem Koloskopie
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330° Sichtfeld mit Endoskopiesystem Fuse®
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Sichtfeld vergleich
170
°
330
°
1.5 cm große Polypen können ohne dieses erweiterte Sichtfeld übersehen wurden
Fallstudien
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Fallstudie: Atlanta, GA
• 65-jähriger Patient, Vorsorgekoloskopie
• Sichtbar am rechten Bildschirm, die 1.5cm adenomatöse Polypen
(roter Kreis)
• Der Arzt konnte den Polyp entfernen, der höchstwahrscheinlich mit
einem herkömmlichen Endoskop nicht sichtbar wäre.
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Fallstudie: St. Paul, MN
• 65-jährige Patientin, Nachkontrolle 5-Jahres-Rhythmus
• 6mm große adenomatöse Läsion im linken Bildschirm sichtbar (roter
Kreis)
• Arzt kommentierte: "Ich hätte diesen Polypen ohne die Seitenansicht
durch das Koloskopiesystem „Fuse“ nicht gesehen."
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Fallstudie: Washington, D.C.
• 55-jähriger Patient stellt sich erstmalig zur Koloskopie vor
• Arzt identifiziert eine 4-5mm Läsion zwischen zwei versteckten Falten
(roter Kreis)
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Klinische Daten
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High Miss Rates Highlight A Critical Need
1st Author Year Journal Results Study Design
Rex
1997 Gastroenterology 24% of adenomas missed with colonoscopy (6% of large
adenomas missed)
183 patients;
Tandem study
Pickhardt 2004 Annals of Internal
Medicine
11.8% of large adenomas (>1cm) missed during
colonoscopy (found with CT)
2/3 of missed adenomas were found on the backside of folds
1,223 patients;
CT colonography vs
colonoscopy
Van Rijn 2006
American
Journal of
Gastroenterology
22% of adenomas missed with colonoscopy
(2.1% of large adenomas missed)
465 patients;
Meta-analysis of 6
tandem studies
Heresbach 2008 Endoscopy 21% of adenomas missed with colonoscopy
(11% of advanced adenomas missed)
286 patients;
Tandem study
Rex 2011 Gastrointestinal
Endoscopy
12.0% of large adenomas in ascending colon missed with
standard colonoscopy (found with retroflexed colonoscope)
1,000 patients;
Retroflexed scope for
second look
Siersema
(TERRACE) 2012
World Journal of
Gastroenterology
31% of adenomas missed with standard colonoscopy
11.8% of large adenomas throughout colon missed with
standard colonoscopy
395 patients; Tandem
exams with and without
Third Eye Retroscope®
Gralnek 2014 The Lancet
Oncology 41% of adenomas missed with standard colonoscopy
185 patients, Tandem
study; Traditional
colonoscope vs Full
Spectrum colonoscope
Third Eye Retroscope is a registered trademark
of Avantis Medical Systems, Inc. 14
FUSE® erkennt 69%
mehr präkanzeröse Polypen
Source:
Gralnek IM, Siersema PD, Rex DK, et al. Standard forward-viewing colonoscopy
versus full-spectrum endoscopy: an international, multicentre, randomised,
tandem colonoscopy trial. The Lancet Oncology 2014; 15: 353-60.
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Reduzierte Kosten im Gesundheitswesen
Source:
Hassan C, Gralnek IM. Cost-effectiveness of “full spectrum endoscopy”
colonoscopy for colorectal cancer screening. Digestive and Liver Disease 47
(2015) 390–394.
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Drei überzeugende Themen
aus Tandem -Studien
• FUSE® erfasst 69% mehr präkanzeröse Polypen, und
somit die Verbesserung der Qualität in der Vorsorge.
• FUSE® fand präkanzeröse Polypen bei 6% der
Patienten, die vorher normale Befunde durch Standard-
Koloskopie hatten.
• 9% der Patienten wurden an einen früheren , genaueren
Überwachungsintervall erinnert.
Source:
Gralnek IM, Siersema PD, Rex DK, et al. Standard forward-viewing colonoscopy versus full-spectrum endoscopy: an international, multicentre,
randomised, tandem colonoscopy trial. The Lancet Oncology 2014; 15: 353-60. 17
vs.
TFV = Traditional Forward View TER = Third Eye Retroscope Fuse® = Full Spectrum Endoscopy
Miss Rates in Tandem Studies
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Rex et al.
1997 Gastro
N=183
vs. = TFV 24%
= TFV 31%
= TFV
41%
Gralnek et al.
2013 DDW
N=185
Adenoma
Miss Rates
vs.
Tandem Studies
Siersema et al.
2012 WJG
N=349
vs.
TFV = Traditional Forward View TER = Third Eye Retroscope Fuse® = Full Spectrum Endoscopy
Additional Detection in Tandem Studies
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Rex et al.
1997 Gastro
N=183
vs. =
=
=
Gralnek et al.
2013 DDW
N=185
2nd Pass 31%
TER 46%
Fuse®
69%
Additional
Adenomas
Detected by
2nd Procedure
vs.
Tandem Studies
Siersema et al.
2012 WJG
N=349
8 Abstracts Presented with Fuse®
Title Author Presented Conclusion
Fuse Colonoscopy Yields Higher Detection of
Advanced and Multiple Adenomas as Compared to
SFV Colonoscopy: A Post-Hoc Per Patient Analysis
from a Randomized Comparative Trial
Cesare Hassan, Ian
Gralnek
UEGW 2014 As compared to SFV colonoscopy, Fuse colonoscopy appears to be more
effective in identifying patients with multiple polyps and polyps up to
9mm in size, including 6-9mm advanced adenomas. These data appear to
further demonstrate the clinical relevance of the additional adenoma
detection of Fuse as previously shown at a ‘per lesion’ level.
Full Spectrum Endoscopy vs Traditional Forward
Viewing Colonoscopy With and Without Right-Colon
Retroflexion: A Randomized, Bicentric Back-to-Back
Study
Ioniss S.
Papanikolaou, et
al.
UEGW 2014 Our initial results show that Fuse colonoscopy could be an advancement
in colonoscopy by detecting more polyps.
Increased Polyp Detection and Decreased Sedation
Usage in an ASC Setting After Implementing
Panorama Endoscopy Platform
Blair S. Lewis, Ian
Gralnek, Melinda
Lugay
ACG 2014 Fuse technology has similar characteristics to standard endoscopes in
terms of cecal intubation and procedure duration, but requires less
sedation while delivering increased polyp detection.
Forward-viewing colonoscopy versus Full-Spectrum
Endoscopy (FUSE) for dysplasia detection with and
without chromoendoscopy in inflammatory bowel
diseases: a prospective, randomized-order, crossover
tandem surveillance colonoscopy study.
RWL Leong, et al. AGW 2014 Fuse significantly increased dysplasia identification in IBD surveillance.
We confirmed the dysplasia yield of random biopsies in the setting of
IBD is extremely low.
Performance Characteristics of colorectal Full
Spectrum Endoscope (Fuse) – prospective, parallel,
randomized study
Helmet Neumann,
et al.
UEGW 2014 Advancement times of the scope to the cecum and withdrawal times were
faster with Fuse as compared to standard FVE. Satisfaction rates of
patients and endoscopists were similar in both groups while patients
needed more sedation and analgesia in FVE group.
A Prospective Cohort Study Evaluating a Novel
Colonoscopy Platform Featuring Full-Spectrum
Endoscopy
Ian Gralnek, et al. Endoscopy
Vol. 44: April
2013
A colonoscopy platform featuring full-spectrum endoscopy appears
feasible, usable, and safe. These results represent an important advance in
colonoscopy imaging technology and should be further pursued in
comparative human studies.
Comparison of standard-forward viewing mode versus
ultrawide-viewing mode of a novel colonoscopy
platform: a prospective, multicenter study in the
detection of simulated polyps in an in vitro model
Ian Gralnek, et al. Gastrointestin
al Endoscopy
Vol. 77, No.
3: 2013
Ultrawide-view colonoscopy significantly improved simulated polyp
detection in a colon model. Clinical studies in human subjects should be
pursued to further evaluate this new endoscopic technology.
Lighting the Fuse: The First Experience Using the 245-
degree View 1G Gastroscope in the US
Matthew
McKinley, et al.
NYSGE 2013 The Fuse 1G endoscope allows for a greatly expanded view of the upper
GI tract, compared to the 150-degree view from a traditional forward
viewing endoscope.
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