Trial Outcomes & Findings for Non-endoscopic Brushing of the Esophagus Using a Non-endoscopic Inflatable Balloon of the Esophagus in Screening for Barrett Esophagus (NCT NCT02451124)

Last Updated: 2019-11-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

156 participants

Primary outcome timeframe

At completion of study procedure (up to 60 minutes)

Results posted on

2019-11-06

Participant Flow

Participant milestones

Participant milestones
Measure	Screening: Non-endoscopic Inflatable Balloon for the Esophagus 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 Study STARTED	156
Overall Study COMPLETED	155
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Screening: Non-endoscopic Inflatable Balloon for the Esophagus 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 Study Withdrawal by Subject	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Screening: Non-endoscopic Inflatable Balloon for the Esophagus n=156 Participants 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
Age, Customized 20-29	2 Participants n=5 Participants
Age, Customized 30-39	4 Participants n=5 Participants
Age, Customized 40-49	10 Participants n=5 Participants
Age, Customized 50-59	36 Participants n=5 Participants
Age, Customized 60-69	45 Participants n=5 Participants
Age, Customized 70-79	39 Participants n=5 Participants
Age, Customized 80-89	11 Participants n=5 Participants
Age, Customized 90-99	1 Participants n=5 Participants
Age, Customized Unknown	8 Participants n=5 Participants
Sex/Gender, Customized Female	48 Participants n=5 Participants
Sex/Gender, Customized Male	107 Participants n=5 Participants
Sex/Gender, Customized Unknown	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	133 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	19 Participants n=5 Participants
Race (NIH/OMB) White	126 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants
Region of Enrollment United States	156 participants n=5 Participants

PRIMARY outcome

Timeframe: At completion of study procedure (up to 60 minutes)

Population: Participants who were successfully able to swallow the device

Outcome measures

Outcome measures
Measure	Low Discomfort n=128 Participants scores of 1-2 (low discomfort)	Intermediate Discomfort n=128 Participants Scores of 3-8 (intermediate discomfort)	High Discomfort n=128 Participants Scores of 9-10 (high discomfort)
Number of Participants Reporting Each Category of Tolerance Assessed by the Tolerance Survey Overall tolerance	92 number of participants	36 number of participants	0 number of participants
Number of Participants Reporting Each Category of Tolerance Assessed by the Tolerance Survey Choking	105 number of participants	22 number of participants	1 number of participants
Number of Participants Reporting Each Category of Tolerance Assessed by the Tolerance Survey Gagging	66 number of participants	58 number of participants	4 number of participants
Number of Participants Reporting Each Category of Tolerance Assessed by the Tolerance Survey Anxiety	96 number of participants	31 number of participants	1 number of participants
Number of Participants Reporting Each Category of Tolerance Assessed by the Tolerance Survey Pain	121 number of participants	7 number of participants	0 number of participants

PRIMARY outcome

Timeframe: Up to 1 year

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Low Discomfort n=50 Participants scores of 1-2 (low discomfort)	Intermediate Discomfort Scores of 3-8 (intermediate discomfort)	High Discomfort Scores of 9-10 (high discomfort)
Sensitivity of the mVIM Assay in Balloon Brushings From Participants With BE	88 % sensitivity	—	—

PRIMARY outcome

Timeframe: Up to 1 year

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Low Discomfort n=36 Participants scores of 1-2 (low discomfort)	Intermediate Discomfort Scores of 3-8 (intermediate discomfort)	High Discomfort Scores of 9-10 (high discomfort)
Specificity of the mVIM Assay in Balloon Brushings From Control Participants With no BE Diagnosis	92 % specificity	—	—

PRIMARY outcome

Timeframe: Up to 7 months

Population: Data not collected

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 7 months

Population: Data not collected

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 7 months

Population: Data not collected

Average methylation of zinc finger protein 793 assay

Outcome measures

Outcome data not reported

Adverse Events

Screening: Non-endoscopic Inflatable Balloon for the Esophagus

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Amitabh Chak

Case Comprehensive Cancer Center

Phone: 2168443217

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place