Trial Outcomes & Findings for Non-Endoscopic Surveillance for Barrett's Esophagus Following Ablative Therapy (NCT NCT02106910)

Last Updated: 2020-11-20

Results Overview

Acceptability will be measured the Impact of Events Scale (IES). This scale was developed to assess the distress associated with a specific life event. Respondents are asked to answer questions to indicate the amount of stress from the event. Scores are calculated with the following scale, (Not at all =0, Rarely =1, Sometimes =3, Often =5). Assessment yields a cumulative score that are calculated from each response, with a total final score ranging from (0-75). High scores represent high test induced distress and lower values represent low distress.

Recruitment status

COMPLETED

Study phase

Target enrollment

138 participants

Primary outcome timeframe

7 days after Baseline

Results posted on

2020-11-20

Participant Flow

Participant milestones

Participant milestones
Measure	Participants With Barrett's and no History of Ablation Participants presenting with Barrett's Esophagus (BE) for routine endoscopic examinations with no history of ablation. Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus.	Participants With Barrett's After Ablation Participants presenting with Barrett's Esophagus (BE) for routine endoscopic examinations after history of at least one session of Endoscopic Eradiation Therapy (EET). Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus.
Overall Study STARTED	49	89
Overall Study COMPLETED	48	88
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Participants With Barrett's and no History of Ablation Participants presenting with Barrett's Esophagus (BE) for routine endoscopic examinations with no history of ablation. Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus.	Participants With Barrett's After Ablation Participants presenting with Barrett's Esophagus (BE) for routine endoscopic examinations after history of at least one session of Endoscopic Eradiation Therapy (EET). Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus.
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

Non-Endoscopic Surveillance for Barrett's Esophagus Following Ablative Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants With Barrett's and no History of Ablation n=49 Participants Participants presenting with Barrett's Esophagus (BE) for routine endoscopic examinations with no history of ablation. Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus.	Participants With Barrett's After Ablation n=89 Participants Participants presenting with Barrett's Esophagus (BE) for routine endoscopic examinations after history of at least one session of Endoscopic Eradiation Therapy (EET). Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus.	Total n=138 Participants Total of all reporting groups
Age, Continuous	63.0 years STANDARD_DEVIATION 10.6 • n=5 Participants	66.3 years STANDARD_DEVIATION 8.8 • n=7 Participants	65.2 years STANDARD_DEVIATION 9.6 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	18 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	71 Participants n=7 Participants	107 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	49 Participants n=5 Participants	88 Participants n=7 Participants	137 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	49 Participants n=5 Participants	89 Participants n=7 Participants	138 Participants n=5 Participants

PRIMARY outcome

Timeframe: 7 days after Baseline

Population: Data unavailable for 2 participants who did not complete assessment.

Outcome measures

Outcome measures
Measure	Participants With Barrett's and no History of Ablation n=48 Participants Participants presenting with Barrett's Esophagus (BE) for routine endoscopic examinations with no history of ablation. Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus.	Participants With Barrett's After Ablation n=88 Participants Participants presenting with Barrett's Esophagus (BE) for routine endoscopic examinations after history of at least one session of Endoscopic Eradiation Therapy (EET). Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus. Period Title: Overall Study
Cytosponge Acceptability by Number of Participants No meaningful impact (Scores 0-8)	46 Participants	81 Participants
Cytosponge Acceptability by Number of Participants Impact Event (Scores 9-25)	2 Participants	6 Participants
Cytosponge Acceptability by Number of Participants Powerful Impact Event (Scores 26-43)	0 Participants	1 Participants
Cytosponge Acceptability by Number of Participants Severe Impact Event (Scores 44-75)	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Immediately after Cytosponge removal

Population: Data unavailable for 2 participants who did not complete assessment.

The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 100-mm line that represents a continuum between "no pain" and "worst pain." Higher scores are representative of worse pain.

Outcome measures

Outcome measures
Measure	Participants With Barrett's and no History of Ablation n=48 Participants Participants presenting with Barrett's Esophagus (BE) for routine endoscopic examinations with no history of ablation. Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus.	Participants With Barrett's After Ablation n=88 Participants Participants presenting with Barrett's Esophagus (BE) for routine endoscopic examinations after history of at least one session of Endoscopic Eradiation Therapy (EET). Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus. Period Title: Overall Study
Mean Post Procedure Pain on the Visual Analog Scale	19.1 units on a scale Standard Deviation 17.7	17.0 units on a scale Standard Deviation 17.5

PRIMARY outcome

Timeframe: 7 days after Baseline

Population: Data unavailable for 3 participants who did not complete assessment.

Participants were asked if they would be willing to repeat the Cytosponge, yes/no.

Outcome measures

Outcome measures
Measure	Participants With Barrett's and no History of Ablation n=47 Participants Participants presenting with Barrett's Esophagus (BE) for routine endoscopic examinations with no history of ablation. Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus.	Participants With Barrett's After Ablation n=88 Participants Participants presenting with Barrett's Esophagus (BE) for routine endoscopic examinations after history of at least one session of Endoscopic Eradiation Therapy (EET). Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus. Period Title: Overall Study
Willingness to Repeat Cytosponge by Number of Participants Yes	44 Participants	86 Participants
Willingness to Repeat Cytosponge by Number of Participants No	3 Participants	2 Participants

PRIMARY outcome

Timeframe: 7 days after Baseline

Population: Data unavailable for 2 participants who did not complete assessment.

Participants were asked to rate both procedures (Cytosponge and esophagogastroduodenoscopy (EGD)) to indicate which procedure they preferred on a scale from 0-10. Higher scores represent greater preference.

Outcome measures

Outcome measures
Measure	Participants With Barrett's and no History of Ablation n=48 Participants Participants presenting with Barrett's Esophagus (BE) for routine endoscopic examinations with no history of ablation. Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus.	Participants With Barrett's After Ablation n=88 Participants Participants presenting with Barrett's Esophagus (BE) for routine endoscopic examinations after history of at least one session of Endoscopic Eradiation Therapy (EET). Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus. Period Title: Overall Study
Mean Procedure Preference Rating Cytosponge Rating, On scale of 1-10	7.8 Units on a scale Standard Deviation 2.3	7.9 Units on a scale Standard Deviation 2.0
Mean Procedure Preference Rating EGD Rating, On scale of 1-10	9.2 Units on a scale Standard Deviation 1.4	9.1 Units on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: Baseline

Population: Data unavailable for 2 participants who did not complete assessment.

The operating characteristics of the Cytosponge™ technique compared against a gold standard of upper endoscopy with biopsies for endoscopic surveillance was evaluated for sensitivity and specificity in the detection of BE in subjects with current (BE) or history of successful radiofrequency ablation for dysplastic BE. A true positive was considered when both the endoscopic biopsy and the Cytosponge detected the goblet cells characteristic of BE. A false positive was considered when the Cytosponge demonstrated these cells while the biopsies did not. A true negative occurred when neither the biopsies nor the Cytosponge showed goblet cells. A false negative was considered when the biopsies did demonstrate goblet cells while the Cytosponge did not. True Positives (TP) and False Negatives calculate sensitivity: (TP)/(TP + FN); True Negatives (TN) and False Positives (FP) are used to calculate specificity: (TN)/(TN + FP).

Outcome measures

Outcome measures
Measure	Participants With Barrett's and no History of Ablation n=48 Participants Participants presenting with Barrett's Esophagus (BE) for routine endoscopic examinations with no history of ablation. Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus.	Participants With Barrett's After Ablation n=88 Participants Participants presenting with Barrett's Esophagus (BE) for routine endoscopic examinations after history of at least one session of Endoscopic Eradiation Therapy (EET). Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus. Period Title: Overall Study
Cytosponge™ Operating Characteristics Specificity to detect BE	92.00 percentage of participants	85.00 percentage of participants
Cytosponge™ Operating Characteristics Sensitivity to detect BE	80.00 percentage of participants	74.00 percentage of participants
Cytosponge™ Operating Characteristics Assay Accuracy	NA percentage of participants Analysis not available.	84.00 percentage of participants

Adverse Events

Participants With Barrett's and no History of Ablation

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Participants With Barrett's After Ablation

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Participants With Barrett's and no History of Ablation n=49 participants at risk Participants presenting with Barrett's Esophagus (BE) for routine endoscopic examinations with no history of ablation. Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus.	Participants With Barrett's After Ablation n=89 participants at risk Participants presenting with Barrett's Esophagus (BE) for routine endoscopic examinations after history of at least one session of Endoscopic Eradiation Therapy (EET). Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus.
Gastrointestinal disorders Sore Throat	14.3% 7/49 • Number of events 7 • From Baseline until approximately 30 days after completion of biomarker panel, an overall approximate total of 45 days. Per study protocol section 7.2, only those events that are potentially related to participation in this research study must be reported.	15.7% 14/89 • Number of events 14 • From Baseline until approximately 30 days after completion of biomarker panel, an overall approximate total of 45 days. Per study protocol section 7.2, only those events that are potentially related to participation in this research study must be reported.

Additional Information

Nicholas J. Shaheen, MD

University of North Carolina at Chapel Hill

Phone: 919-966-7655

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place