Trial Outcomes & Findings for A Minimally-Invasive Sponge on a String Device for Screening for Barrett's Esophagus (NCT NCT02560623)
NCT ID: NCT02560623
Last Updated: 2022-11-17
Results Overview
Number of subjects that answered yes to the self-reported question "Would you choose to have this procedure again to screen for Barrett's esophagus?"
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
242 participants
Primary outcome timeframe
Within 24 hours of the capsule sponge administration
Results posted on
2022-11-17
Participant Flow
Participant milestones
| Measure |
Phase 1: Sponge on a String 25 mm 10 Pores/Inch
In phase 1 of the study, subjects will be assigned to swallow a capsule sponge device 25 mm 10 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy
Capsule Sponge Device 25 mm 10 pores/inch: Polyurethane foam sponge compressed in a vegetable material derived capsule, attached to a string. The capsule is swallowed by the patient. The shell of the capsule dissolves in the gastric fluid releasing the foam device as a sphere which is then pulled out with the attached string, providing brushing/cytology samples of the proximal stomach and esophagus.
|
Phase 1:Sponge on a String 25 mm 20 Pores/Inch
In phase 1 of the study, subjects will be assigned to swallow a capsule sponge device 25 mm 20 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy
Capsule Sponge Device 25 mm 20 pores/inch: Polyurethane foam sponge compressed in a vegetable material derived capsule, attached to a string. The capsule is swallowed by the patient. The shell of the capsule dissolves in the gastric fluid releasing the foam device as a sphere which is then pulled out with the attached string, providing brushing/cytology samples of the proximal stomach and esophagus.
|
Phase 2: Cases - Barrett's Esophagus
In phase 2 of the study, additional subjects will be assigned to swallow a capsule sponge device 25 mm 10 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy
Capsule Sponge Device 25 mm 10 pores/inch: Polyurethane foam sponge compressed in a vegetable material derived capsule, attached to a string. The capsule is swallowed by the patient. The shell of the capsule dissolves in the gastric fluid releasing the foam device as a sphere which is then pulled out with the attached string, providing brushing/cytology samples of the proximal stomach and esophagus.
|
Phase 2: Controls - No Barrett's Esophagus
In phase 2 of the study, additional subjects will be assigned to swallow a capsule sponge device 25 mm 10 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy
Capsule Sponge Device 25 mm 10 pores/inch: Polyurethane foam sponge compressed in a vegetable material derived capsule, attached to a string. The capsule is swallowed by the patient. The shell of the capsule dissolves in the gastric fluid releasing the foam device as a sphere which is then pulled out with the attached string, providing brushing/cytology samples of the proximal stomach and esophagus.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
19
|
22
|
112
|
89
|
|
Overall Study
COMPLETED
|
19
|
20
|
112
|
89
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
Phase 1: Sponge on a String 25 mm 10 Pores/Inch
In phase 1 of the study, subjects will be assigned to swallow a capsule sponge device 25 mm 10 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy
Capsule Sponge Device 25 mm 10 pores/inch: Polyurethane foam sponge compressed in a vegetable material derived capsule, attached to a string. The capsule is swallowed by the patient. The shell of the capsule dissolves in the gastric fluid releasing the foam device as a sphere which is then pulled out with the attached string, providing brushing/cytology samples of the proximal stomach and esophagus.
|
Phase 1:Sponge on a String 25 mm 20 Pores/Inch
In phase 1 of the study, subjects will be assigned to swallow a capsule sponge device 25 mm 20 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy
Capsule Sponge Device 25 mm 20 pores/inch: Polyurethane foam sponge compressed in a vegetable material derived capsule, attached to a string. The capsule is swallowed by the patient. The shell of the capsule dissolves in the gastric fluid releasing the foam device as a sphere which is then pulled out with the attached string, providing brushing/cytology samples of the proximal stomach and esophagus.
|
Phase 2: Cases - Barrett's Esophagus
In phase 2 of the study, additional subjects will be assigned to swallow a capsule sponge device 25 mm 10 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy
Capsule Sponge Device 25 mm 10 pores/inch: Polyurethane foam sponge compressed in a vegetable material derived capsule, attached to a string. The capsule is swallowed by the patient. The shell of the capsule dissolves in the gastric fluid releasing the foam device as a sphere which is then pulled out with the attached string, providing brushing/cytology samples of the proximal stomach and esophagus.
|
Phase 2: Controls - No Barrett's Esophagus
In phase 2 of the study, additional subjects will be assigned to swallow a capsule sponge device 25 mm 10 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy
Capsule Sponge Device 25 mm 10 pores/inch: Polyurethane foam sponge compressed in a vegetable material derived capsule, attached to a string. The capsule is swallowed by the patient. The shell of the capsule dissolves in the gastric fluid releasing the foam device as a sphere which is then pulled out with the attached string, providing brushing/cytology samples of the proximal stomach and esophagus.
|
|---|---|---|---|---|
|
Overall Study
Unable to swallow sponge
|
0
|
1
|
0
|
0
|
|
Overall Study
Intervention prior to sponge administration
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Phase 1: Sponge on a String 25 mm 10 Pores/Inch
n=19 Participants
In phase 1 of the study, subjects will be assigned to swallow a capsule sponge device 25 mm 10 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy
Capsule Sponge Device 25 mm 10 pores/inch: Polyurethane foam sponge compressed in a vegetable material derived capsule, attached to a string. The capsule is swallowed by the patient. The shell of the capsule dissolves in the gastric fluid releasing the foam device as a sphere which is then pulled out with the attached string, providing brushing/cytology samples of the proximal stomach and esophagus.
|
Phase 1:Sponge on a String 25 mm 20 Pores/Inch
n=22 Participants
In phase 1 of the study, subjects will be assigned to swallow a capsule sponge device 25 mm 20 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy
Capsule Sponge Device 25 mm 20 pores/inch: Polyurethane foam sponge compressed in a vegetable material derived capsule, attached to a string. The capsule is swallowed by the patient. The shell of the capsule dissolves in the gastric fluid releasing the foam device as a sphere which is then pulled out with the attached string, providing brushing/cytology samples of the proximal stomach and esophagus.
|
Phase 2: Cases - Barrett's Esophagus
n=112 Participants
In phase 2 of the study, additional subjects will be assigned to swallow a capsule sponge device 25 mm 10 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy
Capsule Sponge Device 25 mm 10 pores/inch: Polyurethane foam sponge compressed in a vegetable material derived capsule, attached to a string. The capsule is swallowed by the patient. The shell of the capsule dissolves in the gastric fluid releasing the foam device as a sphere which is then pulled out with the attached string, providing brushing/cytology samples of the proximal stomach and esophagus.
|
Phase 2: Controls - No Barrett's Esophagus
n=89 Participants
In phase 2 of the study, additional subjects will be assigned to swallow a capsule sponge device 25 mm 10 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy
Capsule Sponge Device 25 mm 10 pores/inch: Polyurethane foam sponge compressed in a vegetable material derived capsule, attached to a string. The capsule is swallowed by the patient. The shell of the capsule dissolves in the gastric fluid releasing the foam device as a sphere which is then pulled out with the attached string, providing brushing/cytology samples of the proximal stomach and esophagus.
|
Total
n=242 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
64 years
n=19 Participants
|
63.5 years
n=22 Participants
|
65.7 years
n=112 Participants
|
58.9 years
n=89 Participants
|
63 years
n=242 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=19 Participants
|
11 Participants
n=22 Participants
|
20 Participants
n=112 Participants
|
47 Participants
n=89 Participants
|
83 Participants
n=242 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=19 Participants
|
11 Participants
n=22 Participants
|
92 Participants
n=112 Participants
|
42 Participants
n=89 Participants
|
159 Participants
n=242 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
19 participants
n=19 Participants
|
22 participants
n=22 Participants
|
112 participants
n=112 Participants
|
89 participants
n=89 Participants
|
242 participants
n=242 Participants
|
PRIMARY outcome
Timeframe: Within 24 hours of the capsule sponge administrationPopulation: Data collected and analyzed for only Phase 1: Sponge on a String 25 mm 10 pores/inch group and Phase 1:Sponge on a String 25 mm 20 pores/inch as this outcome is specific for phase 1 of the study only
Number of subjects that answered yes to the self-reported question "Would you choose to have this procedure again to screen for Barrett's esophagus?"
Outcome measures
| Measure |
Phase 1: Sponge on a String 25 mm 10 Pores/Inch
n=19 Participants
In phase 1 of the study, subjects will be assigned to swallow a capsule sponge device 25 mm 10 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy
Capsule Sponge Device 25 mm 10 pores/inch: Polyurethane foam sponge compressed in a vegetable material derived capsule, attached to a string. The capsule is swallowed by the patient. The shell of the capsule dissolves in the gastric fluid releasing the foam device as a sphere which is then pulled out with the attached string, providing brushing/cytology samples of the proximal stomach and esophagus.
|
Phase 1:Sponge on a String 25 mm 20 Pores/Inch
n=20 Participants
In phase 1 of the study, subjects will be assigned to swallow a capsule sponge device 25 mm 20 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy
Capsule Sponge Device 25 mm 20 pores/inch: Polyurethane foam sponge compressed in a vegetable material derived capsule, attached to a string. The capsule is swallowed by the patient. The shell of the capsule dissolves in the gastric fluid releasing the foam device as a sphere which is then pulled out with the attached string, providing brushing/cytology samples of the proximal stomach and esophagus.
|
|---|---|---|
|
Number of Subjects That Would Have This Procedure Again
|
19 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: Within 24 hours of the capsule sponge administrationPopulation: Data collected and analyzed for only Phase 1: Sponge on a String 25 mm 10 pores/inch group and Phase 1:Sponge on a String 25 mm 20 pores/inch as this outcome is specific for phase 1 of the study only
Measured using a self-reported 5-item tolerability assessment rating discomfort during the procedure on a Likert scale of 0-10; 10 representing the "worst experience" and 0 the "best experience." This scale allows a comprehensive and individual assessment of the degree of pain, choking, gagging, anxiety and overall experienced during the procedure.
Outcome measures
| Measure |
Phase 1: Sponge on a String 25 mm 10 Pores/Inch
n=19 Participants
In phase 1 of the study, subjects will be assigned to swallow a capsule sponge device 25 mm 10 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy
Capsule Sponge Device 25 mm 10 pores/inch: Polyurethane foam sponge compressed in a vegetable material derived capsule, attached to a string. The capsule is swallowed by the patient. The shell of the capsule dissolves in the gastric fluid releasing the foam device as a sphere which is then pulled out with the attached string, providing brushing/cytology samples of the proximal stomach and esophagus.
|
Phase 1:Sponge on a String 25 mm 20 Pores/Inch
n=20 Participants
In phase 1 of the study, subjects will be assigned to swallow a capsule sponge device 25 mm 20 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy
Capsule Sponge Device 25 mm 20 pores/inch: Polyurethane foam sponge compressed in a vegetable material derived capsule, attached to a string. The capsule is swallowed by the patient. The shell of the capsule dissolves in the gastric fluid releasing the foam device as a sphere which is then pulled out with the attached string, providing brushing/cytology samples of the proximal stomach and esophagus.
|
|---|---|---|
|
Tolerability of Swallowing the Sponge Device
Pain
|
1 units on a scale
Interval 0.0 to 1.5
|
0.5 units on a scale
Interval 0.0 to 2.0
|
|
Tolerability of Swallowing the Sponge Device
Choking
|
1 units on a scale
Interval 0.0 to 2.5
|
2 units on a scale
Interval 1.0 to 4.25
|
|
Tolerability of Swallowing the Sponge Device
Gagging
|
2 units on a scale
Interval 1.0 to 6.0
|
4.5 units on a scale
Interval 2.0 to 5.5
|
|
Tolerability of Swallowing the Sponge Device
Anxiety
|
0 units on a scale
Interval 0.0 to 1.0
|
1 units on a scale
Interval 0.0 to 2.5
|
|
Tolerability of Swallowing the Sponge Device
Overall
|
0 units on a scale
Interval 0.0 to 1.0
|
1.5 units on a scale
Interval 0.0 to 5.25
|
PRIMARY outcome
Timeframe: Within 24 hours of the capsule sponge administrationPopulation: Data collected and analyzed for only Phase 1: Sponge on a String 25 mm 10 pores/inch group and Phase 1:Sponge on a String 25 mm 20 pores/inch as this outcome is specific for phase 1 of the study only
Measured using a mucosal injury score (ranging from 1=no trauma to 5=severe) was scored from video recordings of the subsequent endoscopy conducted
Outcome measures
| Measure |
Phase 1: Sponge on a String 25 mm 10 Pores/Inch
n=19 Participants
In phase 1 of the study, subjects will be assigned to swallow a capsule sponge device 25 mm 10 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy
Capsule Sponge Device 25 mm 10 pores/inch: Polyurethane foam sponge compressed in a vegetable material derived capsule, attached to a string. The capsule is swallowed by the patient. The shell of the capsule dissolves in the gastric fluid releasing the foam device as a sphere which is then pulled out with the attached string, providing brushing/cytology samples of the proximal stomach and esophagus.
|
Phase 1:Sponge on a String 25 mm 20 Pores/Inch
n=20 Participants
In phase 1 of the study, subjects will be assigned to swallow a capsule sponge device 25 mm 20 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy
Capsule Sponge Device 25 mm 20 pores/inch: Polyurethane foam sponge compressed in a vegetable material derived capsule, attached to a string. The capsule is swallowed by the patient. The shell of the capsule dissolves in the gastric fluid releasing the foam device as a sphere which is then pulled out with the attached string, providing brushing/cytology samples of the proximal stomach and esophagus.
|
|---|---|---|
|
Mucosal Irritation
|
2 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 2.0
|
PRIMARY outcome
Timeframe: Within 24 hours of the capsule sponge administrationPopulation: Data collected and analyzed for only Phase 1: Sponge on a String 25 mm 10 pores/inch group and Phase 1:Sponge on a String 25 mm 20 pores/inch as this outcome is specific for phase 1 of the study only
Total amount of DNA obtained from esophageal cytology specimens collected by the capsule sponge devices.
Outcome measures
| Measure |
Phase 1: Sponge on a String 25 mm 10 Pores/Inch
n=19 Participants
In phase 1 of the study, subjects will be assigned to swallow a capsule sponge device 25 mm 10 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy
Capsule Sponge Device 25 mm 10 pores/inch: Polyurethane foam sponge compressed in a vegetable material derived capsule, attached to a string. The capsule is swallowed by the patient. The shell of the capsule dissolves in the gastric fluid releasing the foam device as a sphere which is then pulled out with the attached string, providing brushing/cytology samples of the proximal stomach and esophagus.
|
Phase 1:Sponge on a String 25 mm 20 Pores/Inch
n=20 Participants
In phase 1 of the study, subjects will be assigned to swallow a capsule sponge device 25 mm 20 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy
Capsule Sponge Device 25 mm 20 pores/inch: Polyurethane foam sponge compressed in a vegetable material derived capsule, attached to a string. The capsule is swallowed by the patient. The shell of the capsule dissolves in the gastric fluid releasing the foam device as a sphere which is then pulled out with the attached string, providing brushing/cytology samples of the proximal stomach and esophagus.
|
|---|---|---|
|
DNA Yield
|
38.0 μg
Interval 28.5 to 51.5
|
30.8 μg
Interval 26.1 to 41.8
|
SECONDARY outcome
Timeframe: Within 24 hours of the capsule sponge administrationPopulation: Phase 2:Controls - No Barrett's Esophagus were not analyzed for this outcome due to the outcome being specific to BE related dysplasia
The sensitivity methylated DNA markers detected by the capsule sponge, in making a diagnosis of BE related dysplasia will be assessed using endoscopic surveillance biopsy histology as a gold standard.
Outcome measures
| Measure |
Phase 1: Sponge on a String 25 mm 10 Pores/Inch
n=112 Participants
In phase 1 of the study, subjects will be assigned to swallow a capsule sponge device 25 mm 10 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy
Capsule Sponge Device 25 mm 10 pores/inch: Polyurethane foam sponge compressed in a vegetable material derived capsule, attached to a string. The capsule is swallowed by the patient. The shell of the capsule dissolves in the gastric fluid releasing the foam device as a sphere which is then pulled out with the attached string, providing brushing/cytology samples of the proximal stomach and esophagus.
|
Phase 1:Sponge on a String 25 mm 20 Pores/Inch
In phase 1 of the study, subjects will be assigned to swallow a capsule sponge device 25 mm 20 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy
Capsule Sponge Device 25 mm 20 pores/inch: Polyurethane foam sponge compressed in a vegetable material derived capsule, attached to a string. The capsule is swallowed by the patient. The shell of the capsule dissolves in the gastric fluid releasing the foam device as a sphere which is then pulled out with the attached string, providing brushing/cytology samples of the proximal stomach and esophagus.
|
|---|---|---|
|
Sensitivity of Barrett's Dysplasia Detection
|
92 percentage of sensitivity
Interval 85.0 to 96.0
|
—
|
SECONDARY outcome
Timeframe: Within 24 hours of the capsule sponge administrationPopulation: Phase 2: Cases-Barrett's Esophagus were not analyzed for this outcome due to the outcome being specific to correctly identifying subjects without BE related dysplasia
The specificity of methylated DNA markers detected by the capsule sponge, in identifying subjects without a diagnosis of BE related dysplasia will be assessed using endoscopic surveillance biopsy histology as a gold standard.
Outcome measures
| Measure |
Phase 1: Sponge on a String 25 mm 10 Pores/Inch
In phase 1 of the study, subjects will be assigned to swallow a capsule sponge device 25 mm 10 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy
Capsule Sponge Device 25 mm 10 pores/inch: Polyurethane foam sponge compressed in a vegetable material derived capsule, attached to a string. The capsule is swallowed by the patient. The shell of the capsule dissolves in the gastric fluid releasing the foam device as a sphere which is then pulled out with the attached string, providing brushing/cytology samples of the proximal stomach and esophagus.
|
Phase 1:Sponge on a String 25 mm 20 Pores/Inch
n=89 Participants
In phase 1 of the study, subjects will be assigned to swallow a capsule sponge device 25 mm 20 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy
Capsule Sponge Device 25 mm 20 pores/inch: Polyurethane foam sponge compressed in a vegetable material derived capsule, attached to a string. The capsule is swallowed by the patient. The shell of the capsule dissolves in the gastric fluid releasing the foam device as a sphere which is then pulled out with the attached string, providing brushing/cytology samples of the proximal stomach and esophagus.
|
|---|---|---|
|
Specificity of Barrett's Dysplasia Detection
|
—
|
94 percentage of specificity
Interval 87.0 to 98.0
|
Adverse Events
Phase 1: Sponge on a String 25 mm 10 Pores/Inch
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Phase 1:Sponge on a String 25 mm 20 Pores/Inch
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Phase 2: Cases - Barrett's Esophagus
Serious events: 5 serious events
Other events: 31 other events
Deaths: 0 deaths
Phase 2: Controls - No Barrett's Esophagus
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1: Sponge on a String 25 mm 10 Pores/Inch
n=19 participants at risk
In phase 1 of the study, subjects will be assigned to swallow a capsule sponge device 25 mm 10 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy
Capsule Sponge Device 25 mm 10 pores/inch: Polyurethane foam sponge compressed in a vegetable material derived capsule, attached to a string. The capsule is swallowed by the patient. The shell of the capsule dissolves in the gastric fluid releasing the foam device as a sphere which is then pulled out with the attached string, providing brushing/cytology samples of the proximal stomach and esophagus.
|
Phase 1:Sponge on a String 25 mm 20 Pores/Inch
n=22 participants at risk
In phase 1 of the study, subjects will be assigned to swallow a capsule sponge device 25 mm 20 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy
Capsule Sponge Device 25 mm 20 pores/inch: Polyurethane foam sponge compressed in a vegetable material derived capsule, attached to a string. The capsule is swallowed by the patient. The shell of the capsule dissolves in the gastric fluid releasing the foam device as a sphere which is then pulled out with the attached string, providing brushing/cytology samples of the proximal stomach and esophagus.
|
Phase 2: Cases - Barrett's Esophagus
n=112 participants at risk
In phase 2 of the study, additional subjects will be assigned to swallow a capsule sponge device 25 mm 10 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy
Capsule Sponge Device 25 mm 10 pores/inch: Polyurethane foam sponge compressed in a vegetable material derived capsule, attached to a string. The capsule is swallowed by the patient. The shell of the capsule dissolves in the gastric fluid releasing the foam device as a sphere which is then pulled out with the attached string, providing brushing/cytology samples of the proximal stomach and esophagus.
|
Phase 2: Controls - No Barrett's Esophagus
n=89 participants at risk
In phase 2 of the study, additional subjects will be assigned to swallow a capsule sponge device 25 mm 10 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy
Capsule Sponge Device 25 mm 10 pores/inch: Polyurethane foam sponge compressed in a vegetable material derived capsule, attached to a string. The capsule is swallowed by the patient. The shell of the capsule dissolves in the gastric fluid releasing the foam device as a sphere which is then pulled out with the attached string, providing brushing/cytology samples of the proximal stomach and esophagus.
|
|---|---|---|---|---|
|
Surgical and medical procedures
Hospitalization after EGD/ESD procedure
|
0.00%
0/19 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
0.00%
0/22 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
3.6%
4/112 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
0.00%
0/89 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
|
Surgical and medical procedures
Hospitalization: Distal esophageal perforation after endoscopic mucosal perforation
|
0.00%
0/19 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
0.00%
0/22 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
0.89%
1/112 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
0.00%
0/89 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
|
Surgical and medical procedures
ER Presentation: Compliant of sore throat 3 days after procedure
|
0.00%
0/19 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
0.00%
0/22 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
0.00%
0/112 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
1.1%
1/89 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
Other adverse events
| Measure |
Phase 1: Sponge on a String 25 mm 10 Pores/Inch
n=19 participants at risk
In phase 1 of the study, subjects will be assigned to swallow a capsule sponge device 25 mm 10 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy
Capsule Sponge Device 25 mm 10 pores/inch: Polyurethane foam sponge compressed in a vegetable material derived capsule, attached to a string. The capsule is swallowed by the patient. The shell of the capsule dissolves in the gastric fluid releasing the foam device as a sphere which is then pulled out with the attached string, providing brushing/cytology samples of the proximal stomach and esophagus.
|
Phase 1:Sponge on a String 25 mm 20 Pores/Inch
n=22 participants at risk
In phase 1 of the study, subjects will be assigned to swallow a capsule sponge device 25 mm 20 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy
Capsule Sponge Device 25 mm 20 pores/inch: Polyurethane foam sponge compressed in a vegetable material derived capsule, attached to a string. The capsule is swallowed by the patient. The shell of the capsule dissolves in the gastric fluid releasing the foam device as a sphere which is then pulled out with the attached string, providing brushing/cytology samples of the proximal stomach and esophagus.
|
Phase 2: Cases - Barrett's Esophagus
n=112 participants at risk
In phase 2 of the study, additional subjects will be assigned to swallow a capsule sponge device 25 mm 10 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy
Capsule Sponge Device 25 mm 10 pores/inch: Polyurethane foam sponge compressed in a vegetable material derived capsule, attached to a string. The capsule is swallowed by the patient. The shell of the capsule dissolves in the gastric fluid releasing the foam device as a sphere which is then pulled out with the attached string, providing brushing/cytology samples of the proximal stomach and esophagus.
|
Phase 2: Controls - No Barrett's Esophagus
n=89 participants at risk
In phase 2 of the study, additional subjects will be assigned to swallow a capsule sponge device 25 mm 10 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy
Capsule Sponge Device 25 mm 10 pores/inch: Polyurethane foam sponge compressed in a vegetable material derived capsule, attached to a string. The capsule is swallowed by the patient. The shell of the capsule dissolves in the gastric fluid releasing the foam device as a sphere which is then pulled out with the attached string, providing brushing/cytology samples of the proximal stomach and esophagus.
|
|---|---|---|---|---|
|
General disorders
Throat Irritation
|
15.8%
3/19 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
27.3%
6/22 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
20.5%
23/112 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
23.6%
21/89 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
|
Musculoskeletal and connective tissue disorders
Pain under rib cage
|
5.3%
1/19 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
0.00%
0/22 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
0.00%
0/112 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
0.00%
0/89 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
|
Gastrointestinal disorders
Difficulty swallowing
|
5.3%
1/19 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
0.00%
0/22 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
2.7%
3/112 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
3.4%
3/89 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
|
Gastrointestinal disorders
Clearing throat
|
0.00%
0/19 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
4.5%
1/22 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
0.00%
0/112 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
0.00%
0/89 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
|
General disorders
Bruise on lower lip
|
0.00%
0/19 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
4.5%
1/22 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
0.00%
0/112 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
0.00%
0/89 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
|
Gastrointestinal disorders
Heartburn
|
0.00%
0/19 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
0.00%
0/22 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
0.00%
0/112 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
1.1%
1/89 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
|
Gastrointestinal disorders
Dark lesions distal esophagus
|
0.00%
0/19 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
0.00%
0/22 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
0.00%
0/112 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
1.1%
1/89 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
|
Gastrointestinal disorders
Mild rectal bleeding
|
0.00%
0/19 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
0.00%
0/22 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
0.00%
0/112 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
1.1%
1/89 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
|
General disorders
Taste of blood in mouth
|
0.00%
0/19 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
0.00%
0/22 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
0.00%
0/112 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
1.1%
1/89 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/19 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
0.00%
0/22 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
0.00%
0/112 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
1.1%
1/89 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
|
Gastrointestinal disorders
Blood in stool
|
0.00%
0/19 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
0.00%
0/22 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
0.00%
0/112 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
1.1%
1/89 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
|
General disorders
Discomfort behind breast bone
|
0.00%
0/19 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
0.00%
0/22 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
0.89%
1/112 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
0.00%
0/89 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
|
Gastrointestinal disorders
Esophageal pain
|
0.00%
0/19 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
0.00%
0/22 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
0.89%
1/112 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
0.00%
0/89 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
|
General disorders
Mild pain following procedure
|
0.00%
0/19 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
0.00%
0/22 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
0.89%
1/112 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
0.00%
0/89 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
|
Gastrointestinal disorders
Slow transit time of solid food
|
0.00%
0/19 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
0.00%
0/22 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
0.89%
1/112 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
0.00%
0/89 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
|
General disorders
General discomfort
|
0.00%
0/19 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
0.00%
0/22 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
0.89%
1/112 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
0.00%
0/89 • Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place