Know Cancer

or
forgot password

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


N/A
18 Years
80 Years
Not Enrolling
Both
Barrett's Esophagus

Thank you

Trial Information

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


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

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.

Outcome Time Frame:

9-15 months estimated

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

010020-P-001

NCT ID:

NCT00747136

Start Date:

August 2008

Completion Date:

March 2013

Related Keywords:

  • Barrett's Esophagus
  • Barrett's
  • Dysplasia
  • esophageal cancer
  • Patients
  • Barrett Esophagus
  • Esophageal Diseases

Name

Location

Department of Veterans AffairsKansas City, Missouri  64128