NCT02451124

Brief Summary

This pilot clinical trial studies non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the esophagus in screening for Barrett esophagus, a condition where the lining of the esophagus has changed or been replaced with abnormal cells that may lead to cancer. The non-endoscopic inflatable balloon for the esophagus is a capsule balloon that brushes against the walls of the esophagus to collect esophageal samples. Non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the esophagus may help doctors find Barrett esophagus sooner, when it may be easier to treat.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

May 18, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 21, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2017

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

November 6, 2019

Completed
Last Updated

November 6, 2019

Status Verified

November 1, 2019

Enrollment Period

1.1 years

First QC Date

May 18, 2015

Results QC Date

September 27, 2019

Last Update Submit

November 5, 2019

Conditions

Barrett Esophagus

Keywords

BarrettCancerScreening

Outcome Measures

Primary Outcomes (6)

  • Number of Participants Reporting Each Category of Tolerance Assessed by the Tolerance Survey

    Mean tolerance score as assessed by 'tolerance survey' with scores ranging from 0 to 50 with higher scores indicating worse tolerance of interventional balloon device. Subscales include anxiety, pain, choking, gagging, and overall tolerance, with each domain scores ranging from 0 to 10, with higher scores indicating worse tolerance of interventional balloon device.

    At completion of study procedure (up to 60 minutes)

  • Sensitivity of the mVIM Assay in Balloon Brushings From Participants With BE

    Sensitivity of the mVIM assay in balloon brushings from participants with BE as measured by true positives determined by biomarker (mVIM and mCCNA1) analyses of corresponding esophageal balloon derived samples compared to initial diagnosis. The presence of at least 1% of methylated VIM in DNA extracted from the esophageal sampling balloon will be considered a positive assay.

    Up to 1 year

  • Specificity of the mVIM Assay in Balloon Brushings From Control Participants With no BE Diagnosis

    Specificity of the mVIM assay in balloon brushings from control subjects with BE as measured by true negatives determined by biomarker (mVIM and mCCNA1) analyses of corresponding esophageal balloon derived samples compared to initial control status. The presence of at least 1% of methylated VIM in DNA extracted from the esophageal sampling balloon will be considered a positive assay.

    Up to 1 year

  • Average Methylation of Methylated Beta-1,3-glucuronyltransferase 2 Assays

    Average methylation of methylated beta-1,3-glucuronyltransferase 2 assays

    Up to 7 months

  • Performance of the mVIM Assay in Balloon Brushings From Subjects Without BE

    Performance of the mVIM assay in balloon brushings from subjects without BE

    Up to 7 months

  • Average Methylation of Zinc Finger Protein 793 Assay

    Average methylation of zinc finger protein 793 assay

    Up to 7 months

Study Arms (1)

Screening: non-endoscopic inflatable balloon for the esophagus

EXPERIMENTAL

Patients undergo non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the esophagus over 30-60 minutes followed by a standard esophagogastroduodenoscopy. Questionnaire administration will provide self-reported data on patient experiences. laboratory biomarker analysis of biopsy will confirm diagnosis.

Device: non-endoscopic inflatable balloon for the esophagusOther: Questionnaire AdministrationOther: Laboratory Biomarker AnalysisProcedure: esophagogastroduodenoscopy

Interventions

non-endoscopic inflatable balloon for the esophagusDEVICE

Undergo non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the esophagus

Also known as: Balloon
Screening: non-endoscopic inflatable balloon for the esophagus
Questionnaire AdministrationOTHER

Ancillary studies

Screening: non-endoscopic inflatable balloon for the esophagus
Laboratory Biomarker AnalysisOTHER

Correlative studies

Screening: non-endoscopic inflatable balloon for the esophagus
esophagogastroduodenoscopyPROCEDURE

Standard of care, patients digestive tract scoped post balloon brushing

Also known as: EGD
Screening: non-endoscopic inflatable balloon for the esophagus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients are undergoing clinically indicated esophagogastroduodenoscopy (EGD)
  • Patients can provide informed consent
  • Patients have no known coagulopathy and no known history of esophageal varices

You may not qualify if:

  • Patients are not undergoing clinically indicated EGD
  • Patients have known coagulopathies or history of esophageal varices
  • Patients do not have the ability to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Barrett EsophagusNeoplasms

Interventions

Endoscopy, Digestive System

Condition Hierarchy (Ancestors)

Precancerous ConditionsEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Results Point of Contact

Title
Amitabh Chak
Organization
Case Comprehensive Cancer Center
axc22@cwru.edu
2168443217

Study Officials

  • Amitabh Chak

    Case Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2015

First Posted

May 21, 2015

Study Start

July 1, 2015

Primary Completion

August 11, 2016

Study Completion

January 29, 2017

Last Updated

November 6, 2019

Results First Posted

November 6, 2019

Record last verified: 2019-11

Locations

US(2)