WavSTAT® Optical Biopsy System to Target Esophageal Biopsies
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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) |
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 |
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.
Contacts and Locations 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 Esophageal Diseases Digestive System Abnormalities Digestive System Diseases Gastrointestinal Diseases |
ClinicalTrials.gov processed this record on May 23, 2013