Clinical Studies 2016-12-15T15:52:37+00:00

Clinical Studies

 

Demonstrated Efficacy in both screening and surveillance populations:

  • In a multicenter prospective trial of 1,266 patients being screened for Barrett’s esophagus and dysplasia, the addition of WATS to the standard four-quadrant forceps biopsy protocol increased the overall detection of BE by 39.8%.
  • In a second multicenter prospective study of 151 patients, all in high-risk dysplasia surveillance programs at tertiary care centers, the addition of WATS to the standard four-quadrant forceps biopsy protocol increased the detection of esophageal dysplasia by 42%.
  • In patients who had received either radiofrequency ablation or liquid nitrogen spray cryotherapy for Barrett’s esophagus, WATS3D increased detection of residual or recurrent pre-cancerous cells by 57.1% compared to using forceps biopsy alone.

Clinical Studies 2016

Increased Detection of Barrett’s Esophagus-Associated Neoplasia Using Wide Area Transepithelial Sampling in Conjunction with 4-Quadrant Forceps Biopsies: Final Results from a Multi-Center, Prospective, Randomized Trial

Vennalaganti, Prashanth; Eisen, Glenn; Falk, Gary W.; Gerson, Lauren B.; Goldblum, John R.; Gross, Seth A.; Gupta, Neil; Haber, Gregory B.; Infantolino, Anthony; Iyer, Prasad; Johnson, David A.; Kaul, Vivek; Kothari, Shivangi; Lightdale, Charles J.; Schnoll-Sussman, Felice; Shaheen, Nicholas; Smith, Michael S.; Wang, Kenneth K.; Zhang, Yaxia; Sharma, Prateek

Key Findings: Seattle Protocol FB detected 7 cases of HGD/EAC, 6 of which were also detected by WATS3D with the remaining case reported by WATS3D as IND/LGD. WATS3D found an additional 23 cases of HGD/EAC not detected on FB (12 were reported by FB as IND/LGD, while 11 were reported by FB as NDBE only). Conclusion: WATS3D found 4.1x more HGD/EAC than Seattle Protocol random biopsies.

Published Clinical Studies 2015

Inter-Observer Agreement among Pathologists Using Wide-Area Transepithelial Sampling With Computer-Assisted Analysis in Patients With Barrett’s Esophagus

Prashanth R. Vennalaganti, MD , Vijay Naag Kanakadandi, MD, Seth A. Gross,MD, Sravanthi Parasa, MD, MPH, Kenneth K. Wang, MD, Neil Gupta , MD, MPH and Prateek Sharma

Am J Gastroenterol, 28 April 2015; doi: 10.1038/ajg.2015.116

Key Findings: The diagnosis of BE and associated dysplasia using the WATS technique has very high inter-observer agreement. This appears to be significantly higher as compared with previously published data using standard histopathology.

Data Presented at AGA/ASGE Presidential Plenary Session 2014

Esophageal Brush Biopsy With Computer-Assisted Tissue Analysis Increases Detection Of Barrett’s Esophagus And Dysplasia In A Multi-Site Community-Based Setting

Seth Gross MD, Vivek Kaul MD, Anthony Infantolino MD, Michael Smith MD

Key Findings: WATS3D with computer-assisted analysis complements standard FB methods to markedly increase detection of BE and dysplasia. This is the largest series reported to date. In light of recent studies and changes to Barrett’s management guidelines, improved dysplasia detection is critical to appropriate management of these pre-cancerous lesions. This study shows that widespread use of WATS3D in community based gastroenterology practices identifies dysplasia missed by FB, leading to improved care for these patients.

Data Presented at American College of Gastroenterology Annual Meeting – 2014

Inter-Observer Agreement Among Pathologists Using the WATS Technique: Wide Area Transepithelial Sampling of Barrett’s Esophagus Using Computer-Assisted Analysis

Prashanth Vennalaganti MD, Vijay Nag Kanakadandi MD, Sravanthi Parasa MD, MPH, S Gross MD, Neil Gupta MD, MPH, Prateek Sharma MD

Key Findings: The diagnosis of Barrett’s esophagus and associated dysplasia using the WATS technique has a very high inter-observer agreement. WATS technique appears to be significantly better inter observer rates compared to previously published data using standard histopathology. This technology represents a significant improvement over current histopathology assessment.

Poster Presented at American College of Gastroenterology Annual Meeting – 2014

Incremental Benefit of Computer-­‐Assisted Brush-­‐Biopsy (WATS3D) Compared to Standard Endoscopic Biopsy for Detection of Barrett’s Esophagus (BE) and Dysplasia: Systematic Review and Meta‐Analysis

Lauren B. Gerson, MD, MSc Mark Rutenberg, Richard Scott

Key Findings: The addition of WATS3D to standard forceps biopsy increases the diagnostic yield for BE and dysplasia in patients undergoing both screening and surveillance.
– The increased yield was highest for patients undergoing screening for BE or post-ablation examinations.
– The number needed to treat (NNT) to detect an additional case of Barrett’s Esophagus ranged from 4-11 based on the 7 available studies.

Posters Presented at Digestive Disease Week – 2013

Initial Multicenter Experience With Wide Area Transepithelial Esophageal Biopsy With 3D Computer Assisted Analysis (WATS3D) for the Detection of Barrett’s Esophagus

Seth A. Gross, Gina R. Sam, Matthew McKinley, Anthony Infantolino, Felice Schnoll-Sussman, Steven R. DeMeester, Jerey A. Hagen, John C. Lipham, Rahul Kataria, Michael S. Smith

Key Findings:  The increased yield of Barrett’s Esophagus resulting from addition of the WATS3D biopsy from all sites was 20% (9-32%, p <.05).  At three sites that had over 30 WATS3D tests performed or had on-site assistance, the increased detection yield of Barrett’s Esophagus was an average of 46% (20%-88%, p < .05, n=75).

Evaluation of Wide-Area Transepithelial Sampling (WATS3D) Brush Biopsy and Standard Forceps Biopsy (FB) for Post-Ablation Surveillance of Dysplastic/Neoplastic Barrett’s Esophagus (BE)

Donald N. Tsynman, MD, Danielle Marino, MD, Vivek Kaul, MD, FACG, Center For Advanced Therapeutic Endoscopy, Division of Gastroenterology & Hepatology, University of Rochester Medical Center, Rochester, New York

Key Findings:  In this pilot study of post endoscopic therapy surveillance, WATS3D increased the detection rate for Barrett’s Esophagus and/or dysplasia by 27% when used as an adjunctive technique to 4 quadrant forceps biopsy.

Wide Area Transepithelial Sampling (WATS3D): An Adjunct to Surveillance in Barrett’s Esophagus Post Radiofrequency Ablation (RFA)

Chen CL, MD, Infantolino A, MD, Cohen S, MD, Baik D, BS, Division of Gastroenterology and Hepatology, Thomas Jefferson University Hospital, Philadelphia, PA

Key Findings:  Agreement between forceps biopsy and WATS3D was seen in 19/23 patients (82.6%). Of the 4 patients with discordant results, WATS3D upstaged two and down-staged two diagnoses.

Wide Area Transepithelial Sampling (WATS3D) Detects Barrett’s Metaplasia Missed by Forceps Biopsies After Ablation of Short and Long Segment Disease

Rahul D. Kataria, MD, Rebecca Thomas, MD, Michael S. Smith, MD, MBA, Temple University School of Medicine, Philadelphia, PA

Key Findings:  The benefit of WATS3D in post-ablation surveillance appears greater for patients with a history of long segment Barrett’s Esophagus, where 60% more BE was detected.

Posters Presented at American College of Gastroenterology Annual Meeting – 2013

Wide Area Transepithelial Sampling (WATS3D) Improves Detection Of Residual Or Recurrent Intestinal Metaplasia Within The Tubular Esophagus And Squamocolumnar Junction

Rahul D. Kataria MD, Deena Midani MD, Rebecca Thomas MD, Michael S. Smith MD, MBA, Temple University School of Medicine, Philadelphia, PA

Key Findings:  Adjunctive use of WATS3D with forceps increased the detection rate of residual or recurrent intestinal metaplasia by 50% (6/12). Incorporation of WATS3D into standard post ablation surveillance may facilitate earlier detection of residual or recurrent intestinal metaplasia, thereby improving patient outcomes.

Wide Area Transepithelial Sample 3-Dimensional Biopsy Brush With Computer-Assisted Analysis (WATS3D) During ERCP Improves Detection of Biliary Tract Malignancy

Sang H. Kim, M.D., Wallace J. Wang, M.D., Moshe Rubin, M.D., Konika P. Bose, M.D., Anthony J. Nici, M.D., Syed A. Hussain, M.D.
Division of Gastroenterology, New York Hospital Queens / Weill Cornell Medical College

Key Findings:  In this preliminary study of patients with pancreaticobiliary malignancy, WATS3D brushing of the bile duct with computer-assisted analysis proved to have a much higher diagnostic accuracy and positive predictive value than standard brush cytology. Additionally, the WATS3D system was able to detect three additional cases of malignancy or atypia that were not detected by forceps biopsy.

Evaluation of Wide-Area Transepithelial Sampling (WATS3D) Brush Biopsy and Standard Forceps Biopsy for Post-Ablation Surveillance of Dysplastic/Neoplastic Barrett’s Esophagus

 

Danielle Marino, MD, Donald N. Tsynman, MD, Vivek Kaul, MD, FACG, Center For Advanced Therapeutic Endoscopy, Division of Gastroenterology & Hepatology, University of Rochester Medical Center, Rochester, New York

Key Findings: In this study of post-ablation surveillance, WATS3D increased the detection rate for Barrett’s esophagus and/or dysplasia by 27.5% (11/40) when used as an adjunctive technique to standard 4 quadrant forceps biopsy.

Posters Presented at Digestive Disease Week – 2012

Wide Area Transepithelial Sampling (WATS3D) Improves Detection of Short Segment Barrett’s Esophagus (SSBE)

Rahul D. Kataria, BS, Michael S. Smith, MD, MBA, Temple University School of Medicine, Philadelphia, PA

Key Findings: The overall diagnostic yield was increased by 16.7% with adjunctive use of WATS3D in addition to standard forceps biopsy.

Wide Area Transepithelial Sampling (WATS3D) Improves Detection of Barrett’s Esophagus Following Endoscopic Ablation

Rahul D. Kataria, BS, Michael S. Smith, MD, MBA. Temple University School of Medicine, Philadelphia, PA

Key Findings: WATS3D increased the diagnostic yield from only forceps biopsy by 75% (3/4).

Published 2010

Computer-Assisted Brush-Biopsy Analysis for the Detection of Dysplasia in a High-Risk Barrett’s Esophagus Surveillance Population

Anandasabapathy S, Sontag S, Graham DY, Frist S, Bratton J, Harpaz N, Waye JD. Computer-Assisted Brush-Biopsy Analysis for the Detection of Dysplasia in a High-Risk Barrett’s Esophagus Surveillance Population. Dig Dis Sci. 2011 Mar;56(3):761-6. Epub 2010 Oct 27.

Key Findings: These data suggest that computer-assisted brush biopsy is a useful adjunct to standard endoscopic surveillance regimens for the identification of dysplasia in Barrett’s esophagus.

Computer-Assisted Analysis of Abrasive Transepithelial Brush Biopsies Increases the Effectiveness of Esophageal Screening:A Multicenter Prospective Clinical Trial by the EndoCDx Collaborative Group

 

Johanson JF, Frakes J, Eisen D; EndoCDx Collaborative Group. Computer-Assisted Analysis of Abrasive Transepithelial Brush Biopsies Increases the Effectiveness of Esophageal Screening: A Multicenter Prospective Clinical Trial by the EndoCDx Collaborative Group. Dig Dis Sci. 2011 Mar;56(3):767-72. Epub 2010 Dec 4.

Key Findings: These results suggest that adjunctive computer-assisted analysis of an abrasive brush biopsy has the potential to substantially improve the detection of Barrett’s esophagus and dysplasia in screening populations.