New endoscopes and add-on devices to improve colonoscopy performance

Table 1 Available endoscopes and add-on devices for improving colonoscopy outcomes

Wide-angle view colonoscopes		Add-on devices
Brand	Manufacturer	Brand	Manufacturer
Full-spectrum endoscopy platform (Fuse)	EndoChoice, GA, United States	Third-Eye Retroscope (TER)	Avantis Medical Systems, Inc, Sunnyvale, CA. United States
Extra-wide angle view colonoscope	Olympus Co., Tokyo, Japan	Third-Eye Panoramic	Avantis Medical Systems, Inc, Sunnyvale, CA, United States
Self-propelled disposable colonoscopy system (Aer-O-Scope)	GI View Ltd, Ramat Gan, Israel	Endocuff	Arc Medical Design, Leeds, England
		Endocuff-Vision	Arc Medical Design, Leeds, England
		EndoRings	EndoAid Ltd, Caesarea, Israel
		NaviAid G-EYE	SMART Medical Systems Ltd, Ra’anana, Israel

Table 2 Intra-procedural quality indicators

Metric	Definition	Suggested target (references)
Cecal intubation rate	The frequency of completed colonoscopies (cecum is visualized)	Overall: ≥ 90%
		Screening: ≥ 95%[19]
Polyp detection rate	The proportion of patients with at least one polyp	N/A
Adenoma detection rate	The proportion of patients with at least one adenoma	Men: ≥ 30%
		Women: ≥ 20%[19]
Adenoma per colonoscopy	The mean number of adenomas detected per colonoscopy	N/A
Polyp miss rate (PMR)	The proportion of polyps missed during a first pass and detected by a second one. It is used in back-to-back studies.	N/A
Adenoma miss rate	The proportion of adenomas missed during a first pass and detected by a second one. It is used in back-to-back studies.	N/A

N/A: Recommendation not available.

Table 3 New endoscopes and colonoscopy performance improvement

Ref.	Study design	Technology	Comparator	N	Indication	Age (yr), range	CIR (%)	PDR (%)	ADR (%)	APC	PMR (%)	AMR (%)
Gralnek et al[23], 2013	Single-center prospective,	FUSE	None	50	Mixed	18-70	100%	-	-	N/A	N/A	N/A
Gralnek et al[25], 2014	Multicenter, prospective, randomized, tandem	FUSE	SFV	101 vs 96	Mixed	18-70	98.0% vs 98.9%	-	134.0% vs 28.0%	10.64 vs 0.33	10%vs 43%	7% vs 41%
Papanikolaou et al[26], 2017	Multicenter, prospective randomized, tandem	FUSE	SFV+R	107 vs 108	Mixed	41-80	-	-	-	10.61 vs 0.50	13.0% vs 33.5%	10.9% vs 33.7%
Hassan et al[29], 2016	Multicenter, prospective, randomized parallel	FUSE	SFV	328vs 330	Screening after (+) FIT	50-69	92.1% vs 93.3%	-	43.6% vs 45.5%	0.81 vs 0.85	N/A	N/A
Song et al[24], 2016	Singe-center retrospective,	FUSE	None	262	Mixed	22-80	100%	54.20%	36.3%	0.66	N/A	N/A
Rath et al[31], 2015	Multicenter, prospective, parallel	FUSE	SFV	90	-	-	-	36% vs 24.0%	-	-	N/A	N/A
Manes et al[27], 2016 Abstract	Single-center prospective, parallel	FUSE	SFV	264 vs 265	Mixed	18-85	-	56.6% vs 44.3%	35.5% vs 29.9%	-	N/A	N/A
Roepstorff et al[28], 2016 Abstract	Single-center prospective, parallel	FUSE	SFV	109 vs 106	Screening	-	83.4% vs 93.4%	N/A	67.0% vs 59.6%	1.8 vs 1.4	N/A	N/A
Leong et al[30], 2016 Abstract	Single-center, prospective, randomized tandem	FUSE	SFV	25 vs 27	IBD	-	-	-	-	-	225.0% vs 71.4%	-
Uraoka et al[33], 2015	Multicenter, feasibility	EWAVC	None	47	Mixed	-	100%	-	-	0.64	N/A	N/A
Uraoka et al[34], 2013 Abstract	Multicenter, prospective, randomized parallel	EWAVC	SFV	316	Mixed	-	-	-	50.6% vs 45.6%	1.1 vs 1.0	N/A	N/A
Gluck et al[35], 2016	Single-center, prospective, tandem	Aer-O-Scope	SFV	56	Screening	27-72	98.2% vs 98.2%	-	21.4% vs 25.0%	-	12.5% for Aer-O-Scope	-

¹Refers to the first of the tandem examinations;

²Dysplasia miss-rate. N/A: Non-applicable; -: Data not provided; CIR: Cecal intubation rate; PDR: Polyp detection rate; ADR: Adenoma detection rate; APC: Adenoma per colonoscopy; PMR: Polyp miss rate; AMR: Adenoma miss rate; FUSE: Full-spectrum endoscopy platform; SFV: Standard forward view colonoscope; SFV + R: Standard forward view colonoscope + retroflexion in cecum; EWAC: Extra-wide-angle view colonoscope; IBD: Inflammatory bowel disease.

Table 4 Add-on devices and colonoscopy performance improvement

Ref.	Study design	Device	Comparator	N	Indication	Age (yr)	CIR (%)	PDR (%)	ADR (%)	APC	PMR (%)	AMR (%)
Triadafilopoulos et al[36], 2008	Single-center, prospective, pilot	TER	2SFV	24	ScreeningSurveillance	mean: 64					310.5	311.1
Waye et al[39], 2010	Multicenter, prospective, open-label	TER	2SFV	249	ScreeningSurveillance	mean: 63				0.61 vs 0.55	311.7%	39.9%
DeMarco et al[37], 2010	Multicenter, prospective, open-label	TER	2SFV	298	Mixed	mean: 57				0.39 vs 0.34	312.9%	313.8%
Leufkens et al[5], 2011	Multicenter, prospective, randomized, tandem	TER	SFV	176 vs 173	Mixed	range: 23-83					15.9 %vs 32.8%(PP)	18.4% vs 31.4%(PP)
Mishkin et al[38], 2012 Abstract	Single-center, prospective	TER	2SFV	68	Mixed						34.4%	37.8%
Rubin et al[40], 2015	Single center, Prospective, feasibility	TEP	2SFV	33	Mixed	mean: 60	100%		44% overall
Gralnek et al[62], 2014	Single-center, prospective, cohort	G-EYE	None	47	Mixed	mean: 59	100%	53.2	44.70%	0.76	N/A	N/A
Halpern et al[63], 2014	Multicenter, prospective, randomized, tandem	G-EYE	SFV	54 vs 52	Mixed	mean: 55 vs 58	100% vs 100%	-	140.4% vs 25.9%	-	-	7.5% vs 44.7%
Halpern et al[65], 2014 Abstract	Multicenter, prospective, randomized, parallel	G-EYE	SFV	105 vs 117	ScreeningSurveillance	≥ 50	-	-	35.4%vs 23.5%	0.63 vs 0.36	N/A	N/A
Rey et al[64], 2015 Abstract	Multicenter, prospective, randomized, tandem	G-EYE	SFV	25 vs 24	Referral for colonoscopy	-	-	-	-	-	17 vs 41	-
Hendel et al[66], 2015 Abstract	Multicenter, prospective, randomized, parallel	G-EYE HD	SFV	54 vs 50	Mixed	≥ 50	-	76% vs 46%	59% vs 39%	1.15 vs 0.66	N/A	N/A
Shirin et al[67], 2016 Abstract	Multicenter, prospective, randomized, parallel	G-EYE HD	SFV	242 vs 238	Mixed	mean: 65	-	-	49.2% vs 33.8%	0.93 vs 0.57	N/A	N/A
Dik et al[61], 2015	Multicenter, prospective, randomized, tandem	Endorings	SFV	57 vs 59	Mixed	mean: 59	100% vs 100%	168.4% vs 40.7%	149.% vs 28.8%	11.05 vs 0.51	9.1% vs 52.8%	10.4% vs 48.3%
Lenze et al[41], 2014	Single-center, retrospective	Endocuff	None	50	Mixed	mean: 57	98%	-	34%	0.72	N/A	N/A
Floer et al[43], 2014	Multicenter, prospective, randomized, parallel	Endocuff	SFV	249 vs 243	Mixed	median: 64	96% vs 94%	55.4% vs 38.4%	35.4% vs 20.7%	0.58 vs 0.36	N/A	N/A
Biecker et al[44], 2015	Two-center, prospective, randomized, parallel	Endocuff	SFV	245 vs 253	Mixed	median: 67	98% vs 98%	56% vs 42%	36% vs 28%	-	N/A	N/A
Sawatzki et al[42], 2015	Multicenter, prospective, feasibility	Endocuff	None	104	ScreeningSurveillance	mean: 59	99%	72%	47%	-	N/A	N/A
Van Doorn et al[45], 2015	Two-center, prospective, randomized, parallel	Endocuff	SFV	1033(ITT: 504 vs 529	Mixed	median: 65 vs 65	ITT: 98% vs 99%	-	ITT: 52% vs 52%	ITT: 1.36 vs 1.17	N/A	N/A
				PP: 486 vs 514)			PP: 94% vs 99%		PP: 54% vs 53%	PP: 1.44 vs 1.19
De Palma et al[46], 2017	Single-center, prospective, crossover, tandem	Endocuff	SFV	137 vs 137	Mixed	mean: 55 vs 56	100% vs 100%	-	127.7% vs 28.5%	10.63 vs 0.52	-	1.1% vs 29.7%
Floer et al[48], 2014 Abstract	Multicenter, prospective, randomized, parallel	Endocuff	SFV	652	Screening	mean: 64	98.5% vs 99.1%	55.4% vs 39.9%	-	0.9 vs 0.54	N/A	N/A
Marsano et al[50], 2014 Abstract	Multicenter, retrospective	Endocuff	SFV	165 vs 153	ScreeningSurveillance	-	-	-	46.6% vs 30%	0.8vs 0.38	N/A	N/A
Chin et al[53], 2015 Abstract	Single-center, cohort	Endocuff	SFV	93 vs 143	Mixed	-	-	78.5% vs 57.3%	44.1% vs 27.3%	-	N/A	N/A
Patel et al[52], 2016 Abstract	Single-center, cohort	Endocuff	SFV	452 vs 597	Mixed	-	-	79.0% vs 57.4%	51.8% vs 36.3%	1.59 vs 0.91	N/A	N/A
Higham-Kessler et al[56], 2016 Abstract	Single-center, cohort	Endocuff	SFV	77 vs 153	ScreeningSurveillance	-	-		67% vs 62.7%	-	N/A	N/A
Garcia et al[51], 2016 Abstract	Single-center, randomized, parallel	Endocuff	SFV	174 vs 163	Screening	mean: 61	-	29.9% vs 15.9%	22.4% vs 13.4%	0.31 vs 0.22	N/A	N/A
Wada et al[49], 2016 Abstract	Two-center, randomized, parallel	Endocuff	SFV	239 vs 207	-	-	EAC: 98.8%	62% vs 50%	55% vs 40%	-	N/A	N/A
Bensuleiman et al[54], 2016 Abstract	Single-center, prospective, randomized, parallel	Endocuff	CAC	84 vs 75	Screening	-	98% vs 99%	-	53% vs 59%	1.03 vs 1.00	N/A	N/A
Cavallaro et al[55], 2016 Abstract	Single-center, cohort	Endocuff	SFV	605 vs 579	ScreeningSurveillance	mean: 60 vs60	-	-	53% vs 48%	1.1 vs 0.88	N/A	N/A
Triantafyllou et al[47], 2016 Abstract	Multicenter, prospective, randomized, tandem	Endocuff	SFV	100 vs 100	Mixed	mean: 61	-	-	-	10.93 vs 0.53	-	14.7% vs 37.6%
Tsiamoulos et al[58], 2015 Abstract	Single-center, cohort	Endocuff-vision	SFV	133 vs 266	Screening	-	-	-	68.9% vs 58.4%	2.2 vs 1.4	N/A	N/A
Bhattacharyya et al[60], 2016 Abstract	Single-center, prospective, randomized, parallel	Endocuff-vision	SFV	266 vs 265	Screening	-	-	70.3% vs 69.8%	60.9% vs 63%	1.26 vs 1.35	N/A	N/A
Ngu et al[59], 2016 Abstract	Multicenter, prospective, randomized, parallel	Endocuff-vision	SFV	1772	Mixed	mean: 62	96.7% vs 96.4%	-	40.9% vs 36.2%	0.95 vs 0.75	N/A	N/A

¹Refers to the first of the tandem examinations;

²Use of TER/TEP on SFV;

³Miss rate if TER/TEP was not used. N/A: Non applicable; -: Data not provided; CIR: Cecal intubation rate; PDR: Polyp detection rate; ADR: Adenoma detection rate; APC: Adenoma per colonoscopy; PMR: Polyp miss rate; AMR: Adenoma miss rate; SFV: Standard forward view colonoscope; CAC: Cap-assisted colonoscopy; TER: Third-Eye Retroscope; TEP: Third Eye Panoramic Cap; EAC: Endocuff-assisted colonoscopy; ITT: Intention to treat analysis; PP: Per protocol analysis.