Feasibility Testing of a Novel Device (“ESP”) to Improve Endoscopic Stabilization and Visualization. S. K. Sharma, A. Datta, A. Nyugen, C. Dillon, L. Lefevbre, J. F. Cornhill and J. W. Milsom Minimally Invasive New Technologies Group (MINT) New York Presbyterian Hospital and Weill Cornell Medical College, New York, New York. Introduction Flexible endoscopy is the primary diagnostic and therapeutic tool in digestive disease. 10-14 million colonoscopies performed annually [1] Gold standard for detection and prevention of colorectal cancer [2] Mucosal surface area visualized is considered a primary factor, accounting for the varied outcomes reported in colonoscopy [3, 4] Endoluminal treatment approaches may ultimately replace traditional surgery [5] Challenges The Solution: “ESP” Methods Results Next Steps Conclusions Endolumenal Surgical Platform (ESP): developed to meet these challenges. Novel double- balloon endoscopic add-on device We measured the following variables with and without ESP added to the colonoscope. • Reaching caecum in the Kyoto- Kagaku Model (KKM). • Time to reach caecum of KKM. • Migration of colonoscope – centimeter (cm) slip of colonoscope. • Surface area visualization change cm 2 with % change. • Insufflation time to a level deemed acceptable to the operating clinician. ESP device use did: • not affect functionality of endoscope. • Significantly decrease colonoscopic migration • significantly increase mucosal surface area visualised. • significantly reduce time taken to reach clinically acceptable visualization - Lack of stability - Poor visualization Variable Colonoscope Colonoscope + ESP (* = p<0.05) Intubated Caecum (%) 100 100 Time to reach caecum (sec) 38 47* Colonoscope Migration (cm) 60 0* Surface Area Visualized (cm 2 ) 34 (straight) 39 (flexure) 50 (both)* Time for maximum visualization (sec) 35 (straight) 57 (flexure) 19 (straight)* 35 (flexure)* Straight segment Flexure segment Colonoscope Colonoscope + ESP Validate results in-vivo. Evaluate therapeutic application benefits Kyoto-Kagaku Model with customized model colon 1. Zauber AG, Winawer SJ, O'Brien MJ, Lansdorp-Vogelaar I, van Ballegooijen M, Hankey BF, et al. Colonoscopic polypectomy and long-term prevention of colorectal-cancer deaths. The New England journal of medicine. 2012;366(8):687-96. Epub 2012/02/24. 2. Seeff LC, Richards TB, Shapiro JA, Nadel MR, Manninen DL, Given LS, et al. How many endoscopies are performed for colorectal cancer screening? Results from CDC's survey of endoscopic capacity. Gastroenterology. 2004;127(6):1670-7. Epub 2004/12/04. 3. Anderloni A, Jovani M, Hassan C, Repici A. Advances, problems, and complications of polypectomy. Clinical and experimental gastroenterology. 2014;7:285-96. Epub 2014/09/12. 4. Samadder NJ, Curtin K, Tuohy TM, Pappas L, Boucher K, Provenzale D, et al. Characteristics of missed or interval colorectal cancer and patient survival: a population-based study. Gastroenterology. 2014;146(4):950-60. Epub 2014/01/15. 5. Sharma SK, Milsom JW and Yoo J. Can endoscopy and laparoscopy be combined to remove complex polyps? Colorectal Cancer. 2013;2(6):479-82. References Colonoscope ESP Despite the importance and versatility of flexible endoscopy challenges in it’s execution still exist Colonoscope view

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Page 1: Feasibility Testing of a Novel Device (“ESP”) to Improve

Feasibility Testing of a Novel Device (“ESP”) to Improve Endoscopic Stabilization and Visualization.S. K. Sharma, A. Datta, A. Nyugen, C. Dillon, L. Lefevbre, J. F. Cornhill and J. W. Milsom

Minimally Invasive New Technologies Group (MINT) New York Presbyterian Hospital and Weill Cornell Medical

College, New York, New York.IntroductionFlexible endoscopy is the primary diagnostic and therapeutic tool in digestive disease.

10-14 million colonoscopies performed annually [1]

Gold standard for detection and prevention of colorectal cancer [2]

Mucosal surface area visualized is considered a primary factor, accounting for the varied outcomes reported in colonoscopy [3, 4]

Endoluminal treatment approaches may ultimately replace traditional surgery[5]

Challenges

The Solution: “ESP”

Methods

Results

Next Steps

Conclusions

Endolumenal Surgical Platform (ESP): developed to meet these challenges.

Novel double-balloon endoscopic add-on device We measured the following variables

with and without ESP added to the colonoscope.

•  Reaching caecum in the Kyoto-Kagaku Model (KKM).

•  Time to reach caecum of KKM.•  Migration of colonoscope –

centimeter (cm) slip of colonoscope.

•  Surface area visualization change cm2 with % change.

•  Insufflation time to a level deemed acceptable to the operating

clinician.

ESP device use did: •  not affect functionality of

endoscope.•  Significantly decrease colonoscopic migration

•  significantly increase mucosal surface area visualised.

•  significantly reduce time taken to reach clinically acceptable

visualization

- Lack of stability- Poor visualization

Variable Colonoscope Colonoscope + ESP (* = p<0.05)

Intubated Caecum (%) 100 100

Time to reach caecum (sec) 38 47*

Colonoscope Migration (cm)

60 0*

Surface Area Visualized (cm2)

34 (straight)39 (flexure)

50 (both)*

Time for maximum visualization (sec)

35 (straight)57 (flexure)

19 (straight)*35 (flexure)*

Straight segment

Flexure segment

Colonoscope Colonoscope + ESP

Validate results in-vivo.

Evaluate therapeutic application benefits

Kyoto-Kagaku Model with customized model colon

1. Zauber AG, Winawer SJ, O'Brien MJ, Lansdorp-Vogelaar I, van Ballegooijen M, Hankey BF, et al. Colonoscopic polypectomy and long-term prevention of colorectal-cancer deaths. The New England journal of medicine. 2012;366(8):687-96. Epub 2012/02/24.2. Seeff LC, Richards TB, Shapiro JA, Nadel MR, Manninen DL, Given LS, et al. How many endoscopies are performed for colorectal cancer screening? Results from CDC's survey of endoscopic capacity. Gastroenterology. 2004;127(6):1670-7. Epub 2004/12/04.3. Anderloni A, Jovani M, Hassan C, Repici A. Advances, problems, and complications of polypectomy. Clinical and experimental gastroenterology. 2014;7:285-96. Epub 2014/09/12.4. Samadder NJ, Curtin K, Tuohy TM, Pappas L, Boucher K, Provenzale D, et al. Characteristics of missed or interval colorectal cancer and patient survival: a population-based study. Gastroenterology. 2014;146(4):950-60. Epub 2014/01/15.5. Sharma SK, Milsom JW and Yoo J. Can endoscopy and laparoscopy be combined to remove complex polyps? Colorectal Cancer. 2013;2(6):479-82.

References

Colonoscope

ESP

Despite the importance and versatility of flexible endoscopy challenges in it’s execution still exist

Colonoscope view