Expired Study
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Kansas City, Missouri 64128


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.


Study summary:

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.


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.


Study is Available At:


Original ID:

010020-P-001


NCT ID:

NCT00747136


Secondary ID:


Study Acronym:


Brief Title:

WavSTAT® Optical Biopsy System to Target Esophageal Biopsies


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


Overall Status:

Terminated


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

80 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

SpectraScience


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

Study has been terminated for inadequate res


Study Type:

Observational


Study Design:

Observational Model: Case-Only, Time Perspective:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

47


Enrollment Type:

Actual


Study Dates

Start Date:August 2008
Completion Date:March 2013
Completion Type:Actual
Primary Completion Date:October 2012
Primary Completion Type:Actual
Verification Date:April 2011
Last Changed Date:April 12, 2016
First Received Date:September 2, 2008

Study Outcomes

Outcome Type:Primary 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.
Time Frame:9-15 months estimated
Safety Issues:False

Study Interventions

There are no available Study Interventions

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:SpectraScience

Samples and Retentions

Sample Retention:Samples Without DNA
Description: esophageal biopsies will be collected.
Study Population: Patients with Barrett's esophagus
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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