WavSTAT® Optical Biopsy System to Target Esophageal Biopsies

Barrett's Esophagus Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00747136
• Other study ID #: 010020-P-001
• Status: Terminated
• Phase: N/A
• First received: September 2, 2008
• Last updated: April 12, 2016
• Start date: August 2008
• Est. completion date: March 2013

Study information

• Verified date: April 2011
• Source: SpectraScience
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 47
• Est. completion date: March 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus

Locations

Country	Name	City	State
United States	Department of Veterans Affairs	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
SpectraScience

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		9-15 months estimated	No