Barrett's EsophagusNCT00747136
WavSTAT® Optical Biopsy System to Target Esophageal Biopsies
An observational study of Barrett's Esophagus, run by SpectraScience at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Barrett's Esophagus
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Mar 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Barrett's esophagus
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Veterans Affairs
Kansas City, Missouri, 64128
About this study
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
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.
Read the 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.
- Conditions
- Barrett's Esophagus
- Keywords
- Barrett's, Dysplasia, esophageal cancer, Patients
- Medical subject headings
- Barrett Esophagus, Esophageal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9-15 months estimated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2008 (estimated)
- Study startAug 2008
- Primary completionOct 2012
- Study completionMar 2013
Why it stopped: Study has been terminated for inadequate results
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett's EsophagusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- SpectraScience
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00747136
- Sponsor's protocol ID
- 010020-P-001
- Status last verified
- Apr 2011
- First submitted
- 2 Sep 2008
- Last updated
- 14 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00747136
- Acronym / sponsor ID
- 010020-P-001
- Conditions
- Barrett's Esophagus
- Keywords
- Barrett's, Dysplasia, esophageal cancer, Patients
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study has been terminated for inadequate results
- Enrolment
- 47 participants (actual)
- Lead sponsor
- SpectraScienceUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Oct 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 4 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Barrett's esophagus
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study was stopped early (reason given: Study has been terminated for inadequate results). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Barrett's Esophagus, run by SpectraScience at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study has been terminated for inadequate results). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2016.