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WavSTAT® Optical Biopsy System to Target Esophageal Biopsies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00747136
Recruitment Status : Terminated (Study has been terminated for inadequate results)
First Posted : September 4, 2008
Last Update Posted : April 14, 2016
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study is to demonstrate the clinical utility of the WavSTAT Optical Biopsy System as an adjunctive tool to improve the endoscopist's clinical sensitivity to identify dysplasia or cancer in the esophagus.

Condition or disease
Barrett's Esophagus

Detailed Description:
In the clinical portion of this prospective study, the algorithm developed in the preclinical evaluation will be blindly tested using the pathologists' assessment of the biopsies as a gold standard to determine the clinical sensitivity and specificity of the WavSTAT Optical Biopsy System to identify dysplastic or cancerous tissue in the esophagus. In addition, the endoscopist's unaided clinical sensitivity and specificity to identify dysplasia or cancerous tissue will also be determined by recording the endoscopist's visual assessment of whether the physical biopsy has dysplasia or cancer or does not have dysplasia or cancer prior to performing the biopsy The endoscopist's assessment will be correlated and compared with the pathologist's interpretation. The clinical utility of the WavSTAT System to improve the endoscopist's clinical sensitivity to identify dysplasia or cancer in the esophagus will be evaluated by testing the hypothesis that the sensitivity of a WavSTAT-assisted endoscopic examination improves that of standard endoscopy alone.

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Study Type : Observational
Actual Enrollment : 47 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective Evaluation of the WavSTAT® Optical Biopsy System to Target Esophageal Biopsies: An Adjunctive Tool to Assist the Endoscopist to Identify Dysplasia or Cancer
Study Start Date : August 2008
Actual Primary Completion Date : October 2012
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Primary Outcome Measures :
  1. Determine sensitivity/specificity to identify dysplasia/cancer in the esophagus WavSTAT System alone, endoscopist alone/combination of WavSTAT and endoscopist. Sensitivity of the endoscopist will be compared to combination of endoscopist and WavSTAT. [ Time Frame: 9-15 months estimated ]

Biospecimen Retention:   Samples Without DNA
esophageal biopsies will be collected.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Barrett's esophagus

Inclusion Criteria:

  • The patient is between 18 and 80 years of age.
  • The patient is willing to sign an informed consent form.
  • The patient is a candidate for endoscopic examination
  • Female patients of child-bearing age, uncertain of pregnancy status, must have a negative pregnancy test.

Exclusion Criteria:

  • The patient has congenital deformities, which preclude a physical biopsy procedure during endoscopy.
  • The patient is pregnant or nursing by admission.
  • The patient has other contraindications for physical biopsy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00747136

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United States, Missouri
Department of Veterans Affairs
Kansas City, Missouri, United States, 64128
Sponsors and Collaborators
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Responsible Party: SpectraScience Identifier: NCT00747136    
Other Study ID Numbers: 010020-P-001
First Posted: September 4, 2008    Key Record Dates
Last Update Posted: April 14, 2016
Last Verified: April 2011
Keywords provided by SpectraScience:
esophageal cancer
Additional relevant MeSH terms:
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Barrett Esophagus
Precancerous Conditions
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases