NCT00747136

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 2, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 4, 2008

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

April 14, 2016

Status Verified

April 1, 2011

Enrollment Period

4.2 years

First QC Date

September 2, 2008

Last Update Submit

April 12, 2016

Conditions

Barrett's Esophagus

Keywords

Barrett'sDysplasiaesophageal cancerPatients

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Barrett's esophagus

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Veterans Affairs

Kansas City, Missouri, 64128, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

esophageal biopsies will be collected.

MeSH Terms

Conditions

Barrett EsophagusEsophageal Neoplasms

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck Neoplasms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2008

First Posted

September 4, 2008

Study Start

August 1, 2008

Primary Completion

October 1, 2012

Study Completion

March 1, 2013

Last Updated

April 14, 2016

Record last verified: 2011-04

Locations

US(1)