WavSTAT® Optical Biopsy System to Target Esophageal Biopsies

This study has suspended participant recruitment.
(Study has been suspended while company continues to develop the technology)
Sponsor:
Information provided by:
SpectraScience
ClinicalTrials.gov Identifier:
NCT00747136
First received: September 2, 2008
Last updated: April 11, 2011
Last verified: April 2011
  Purpose

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
Barrett's Esophagus

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by SpectraScience:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

esophageal biopsies will be collected.


Estimated Enrollment: 250
Study Start Date: August 2008
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with Barrett's esophagus

Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00747136

Locations
United States, Missouri
Department of Veterans Affairs
Kansas City, Missouri, United States, 64128
Sponsors and Collaborators
SpectraScience
  More Information

No publications provided

Responsible Party: James Dorst, COO, SpectraScience, Inc
ClinicalTrials.gov Identifier: NCT00747136     History of Changes
Other Study ID Numbers: 010020-P-001
Study First Received: September 2, 2008
Last Updated: April 11, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by SpectraScience:
Barrett's
Dysplasia
esophageal cancer
Patients

Additional relevant MeSH terms:
Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on September 16, 2014