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Non-endoscopic Brushing of the Esophagus Using a Non-endoscopic Inflatable Balloon of the Esophagus in Screening for Barrett Esophagus

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ClinicalTrials.gov Identifier: NCT02451124
Recruitment Status : Completed
First Posted : May 21, 2015
Results First Posted : November 6, 2019
Last Update Posted : November 6, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Screening
Condition Barrett Esophagus
Interventions Device: non-endoscopic inflatable balloon for the esophagus
Other: Questionnaire Administration
Other: Laboratory Biomarker Analysis
Procedure: esophagogastroduodenoscopy
Enrollment 156
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Screening: Non-endoscopic Inflatable Balloon for the Esophagus
Hide Arm/Group Description

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.

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

Questionnaire Administration: Ancillary studies

Laboratory Biomarker Analysis: Correlative studies

esophagogastroduodenoscopy: Standard of care, patients digestive tract scoped post balloon brushing

Period Title: Overall Study
Started 156
Completed 155
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Screening: Non-endoscopic Inflatable Balloon for the Esophagus
Hide Arm/Group Description

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.

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

Questionnaire Administration: Ancillary studies

Laboratory Biomarker Analysis: Correlative studies

esophagogastroduodenoscopy: Standard of care, patients digestive tract scoped post balloon brushing

Overall Number of Baseline Participants 156
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 156 participants
20-29
2
   1.3%
30-39
4
   2.6%
40-49
10
   6.4%
50-59
36
  23.1%
60-69
45
  28.8%
70-79
39
  25.0%
80-89
11
   7.1%
90-99
1
   0.6%
Unknown
8
   5.1%
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 156 participants
Female
48
  30.8%
Male
107
  68.6%
Unknown
1
   0.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 156 participants
Hispanic or Latino
1
   0.6%
Not Hispanic or Latino
22
  14.1%
Unknown or Not Reported
133
  85.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 156 participants
American Indian or Alaska Native
0
   0.0%
Asian
4
   2.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
19
  12.2%
White
126
  80.8%
More than one race
0
   0.0%
Unknown or Not Reported
7
   4.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 156 participants
156
1.Primary Outcome
Title Number of Participants Reporting Each Category of Tolerance Assessed by the Tolerance Survey
Hide Description 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.
Time Frame At completion of study procedure (up to 60 minutes)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were successfully able to swallow the device
Arm/Group Title Low Discomfort Intermediate Discomfort High Discomfort
Hide Arm/Group Description:
scores of 1-2 (low discomfort)
Scores of 3-8 (intermediate discomfort)
Scores of 9-10 (high discomfort)
Overall Number of Participants Analyzed 128 128 128
Measure Type: Number
Unit of Measure: number of participants
Anxiety 96 31 1
Pain 121 7 0
Choking 105 22 1
Gagging 66 58 4
Overall tolerance 92 36 0
2.Primary Outcome
Title Sensitivity of the mVIM Assay in Balloon Brushings From Participants With BE
Hide Description 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.
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable Cases. Cases are participants with diagnosed BE. Some cases not evaluable because of failure to swallow device, failure to obtain adequate DNA from balloon tips, or other exclusionary reasons.
Arm/Group Title Screening: Non-endoscopic Inflatable Balloon for the Esophagus
Hide Arm/Group Description:

Patients undergo non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the esophagus over 3-15 minutes followed by a standard EGD. Questionnaire administration will provide self-reported data on patient experiences. laboratory biomarker analysis of biopsy will confirm diagnosis.

Questionnaire Administration: Ancillary studies

Laboratory Biomarker Analysis: Correlative studies

EGD: Standard of care, patients' digestive tract examined with EGD post balloon brushing

Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: % sensitivity
88
3.Primary Outcome
Title Specificity of the mVIM Assay in Balloon Brushings From Control Participants With no BE Diagnosis
Hide Description 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.
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable Controls. Controls were evaluable participants with with no diagnosed disease. Some controls not evaluable because of failure to swallow device, failure to obtain adequate DNA from balloon tips, or other exclusionary reasons.
Arm/Group Title Screening: Non-endoscopic Inflatable Balloon for the Esophagus
Hide Arm/Group Description:

Patients undergo non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the esophagus over 3-15 minutes followed by a standard EGD. Questionnaire administration will provide self-reported data on patient experiences. laboratory biomarker analysis of biopsy will confirm diagnosis.

Questionnaire Administration: Ancillary studies

Laboratory Biomarker Analysis: Correlative studies

EGD: Standard of care, patients' digestive tract examined with EGD post balloon brushing

Overall Number of Participants Analyzed 36
Measure Type: Number
Unit of Measure: % specificity
92
4.Primary Outcome
Title Average Methylation of Methylated Beta-1,3-glucuronyltransferase 2 Assays
Hide Description Average methylation of methylated beta-1,3-glucuronyltransferase 2 assays
Time Frame Up to 7 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected
Arm/Group Title Screening: Non-endoscopic Inflatable Balloon for the Esophagus
Hide Arm/Group Description:

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.

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

Questionnaire Administration: Ancillary studies

Laboratory Biomarker Analysis: Correlative studies

esophagogastroduodenoscopy: Standard of care, patients digestive tract scoped post balloon brushing

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Primary Outcome
Title Performance of the mVIM Assay in Balloon Brushings From Subjects Without BE
Hide Description Performance of the mVIM assay in balloon brushings from subjects without BE
Time Frame Up to 7 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected
Arm/Group Title Screening: Non-endoscopic Inflatable Balloon for the Esophagus
Hide Arm/Group Description:

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.

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

Questionnaire Administration: Ancillary studies

Laboratory Biomarker Analysis: Correlative studies

esophagogastroduodenoscopy: Standard of care, patients digestive tract scoped post balloon brushing

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Primary Outcome
Title Average Methylation of Zinc Finger Protein 793 Assay
Hide Description Average methylation of zinc finger protein 793 assay
Time Frame Up to 7 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected
Arm/Group Title Screening: Non-endoscopic Inflatable Balloon for the Esophagus
Hide Arm/Group Description:

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.

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

Questionnaire Administration: Ancillary studies

Laboratory Biomarker Analysis: Correlative studies

esophagogastroduodenoscopy: Standard of care, patients digestive tract scoped post balloon brushing

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame at procedure (average of 24 hours)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Screening: Non-endoscopic Inflatable Balloon for the Esophagus
Hide Arm/Group Description

Patients undergo non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the esophagus over 3-15 minutes followed by a standard EGD. Questionnaire administration will provide self-reported data on patient experiences. laboratory biomarker analysis of biopsy will confirm diagnosis.

Questionnaire Administration: Ancillary studies

Laboratory Biomarker Analysis: Correlative studies

EGD: Standard of care, patients' digestive tract examined with EGD post balloon brushing

All-Cause Mortality
Screening: Non-endoscopic Inflatable Balloon for the Esophagus
Affected / at Risk (%)
Total   0/156 (0.00%) 
Hide Serious Adverse Events
Screening: Non-endoscopic Inflatable Balloon for the Esophagus
Affected / at Risk (%)
Total   0/156 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Screening: Non-endoscopic Inflatable Balloon for the Esophagus
Affected / at Risk (%)
Total   0/156 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Amitabh Chak
Organization: Case Comprehensive Cancer Center
Phone: 2168443217
EMail: axc22@cwru.edu
Layout table for additonal information
Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02451124    
Other Study ID Numbers: CASE6214
NCI-2015-00246 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CASE6214 ( Other Identifier: Case Comprehensive Cancer Center )
P30CA043703 ( U.S. NIH Grant/Contract )
U54CA163060 ( U.S. NIH Grant/Contract )
P50CA150964 ( U.S. NIH Grant/Contract )
First Submitted: May 18, 2015
First Posted: May 21, 2015
Results First Submitted: September 27, 2019
Results First Posted: November 6, 2019
Last Update Posted: November 6, 2019