Trial Outcomes & Findings for Comparative Effectiveness of Endoscopic Assessment of Gastroesophageal Reflux and Barretts Esophagus (NCT NCT01288612)
NCT ID: NCT01288612
Last Updated: 2015-01-07
Results Overview
This outcome measure was defined as the proportion of subjects who agreed to undergo esophageal assessment in the three groups out of those who were eligible to be contacted for participation in screening.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
459 participants
Primary outcome timeframe
Approximately 2 weeks after invitation letter was sent
Results posted on
2015-01-07
Participant Flow
Eligible participants were identified using the Rochester Epidemiology Project resources from Olmsted County, Minnesota residents. The study took place between 1 April 2011 and 30 October 2013.
Participant milestones
| Measure |
Sedated Endoscopy
Sedated esophagogastroduodenoscopy with biopsy
Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl.
|
Transnasal Endoscopy at Hospital Unit
Unsedated transnasal endoscopy at hospital unit.
Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.
|
Transnasal Endoscopy at Mobile Unit
Unsedated transnasal endoscopy in mobile research van
Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.
|
|---|---|---|---|
|
Overall Study
STARTED
|
150
|
151
|
158
|
|
Overall Study
Contacted
|
139
|
135
|
138
|
|
Overall Study
Agreed to Take Part
|
61
|
72
|
76
|
|
Overall Study
COMPLETED
|
61
|
69
|
76
|
|
Overall Study
NOT COMPLETED
|
89
|
82
|
82
|
Reasons for withdrawal
| Measure |
Sedated Endoscopy
Sedated esophagogastroduodenoscopy with biopsy
Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl.
|
Transnasal Endoscopy at Hospital Unit
Unsedated transnasal endoscopy at hospital unit.
Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.
|
Transnasal Endoscopy at Mobile Unit
Unsedated transnasal endoscopy in mobile research van
Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.
|
|---|---|---|---|
|
Overall Study
Unable to contact
|
11
|
16
|
20
|
|
Overall Study
Declined
|
78
|
63
|
62
|
|
Overall Study
Unable to intubate
|
0
|
3
|
0
|
Baseline Characteristics
Comparative Effectiveness of Endoscopic Assessment of Gastroesophageal Reflux and Barretts Esophagus
Baseline characteristics by cohort
| Measure |
Sedated Endoscopy
n=150 Participants
Sedated esophagogastroduodenoscopy with biopsy
Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl.
|
Transnasal Endoscopy at Hospital Unit
n=151 Participants
Unsedated transnasal endoscopy at hospital unit.
Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.
|
Transnasal Endoscopy at Mobile Unit
n=158 Participants
Unsedated transnasal endoscopy in mobile research van
Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.
|
Total
n=459 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 9 • n=5 Participants
|
64 years
STANDARD_DEVIATION 10 • n=7 Participants
|
64 years
STANDARD_DEVIATION 10 • n=5 Participants
|
65 years
STANDARD_DEVIATION 9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
250 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
209 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
150 participants
n=5 Participants
|
151 participants
n=7 Participants
|
158 participants
n=5 Participants
|
459 participants
n=4 Participants
|
|
Reflux Symptoms
Heartburn or acid regurgitation > 1/week
|
12 participants
n=5 Participants
|
16 participants
n=7 Participants
|
15 participants
n=5 Participants
|
43 participants
n=4 Participants
|
|
Reflux Symptoms
Heartburn or acid regurgitation < 1/week
|
62 participants
n=5 Participants
|
67 participants
n=7 Participants
|
68 participants
n=5 Participants
|
197 participants
n=4 Participants
|
|
Reflux Symptoms
No heartburn or acid regurgitation
|
76 participants
n=5 Participants
|
68 participants
n=7 Participants
|
75 participants
n=5 Participants
|
219 participants
n=4 Participants
|
|
Education
Less than high school
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
12 participants
n=4 Participants
|
|
Education
High school or some college
|
77 participants
n=5 Participants
|
76 participants
n=7 Participants
|
72 participants
n=5 Participants
|
225 participants
n=4 Participants
|
|
Education
College/professional training
|
64 participants
n=5 Participants
|
67 participants
n=7 Participants
|
74 participants
n=5 Participants
|
205 participants
n=4 Participants
|
|
Education
Unknown/not answered
|
7 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
17 participants
n=4 Participants
|
|
Employment
Employed
|
48 participants
n=5 Participants
|
63 participants
n=7 Participants
|
56 participants
n=5 Participants
|
167 participants
n=4 Participants
|
|
Employment
Unemployed/homemaker
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
11 participants
n=5 Participants
|
27 participants
n=4 Participants
|
|
Employment
Retired
|
87 participants
n=5 Participants
|
75 participants
n=7 Participants
|
86 participants
n=5 Participants
|
248 participants
n=4 Participants
|
|
Employment
Unknown/not answered
|
7 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
17 participants
n=4 Participants
|
|
Marital Status
Married
|
115 participants
n=5 Participants
|
118 participants
n=7 Participants
|
116 participants
n=5 Participants
|
349 participants
n=4 Participants
|
|
Marital Status
Not married (single/widowed/divorced/separated)
|
34 participants
n=5 Participants
|
33 participants
n=7 Participants
|
41 participants
n=5 Participants
|
108 participants
n=4 Participants
|
|
Marital Status
Unknown/not answered
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Use of Proton Pump Inhibitor (PPI)
Yes
|
25 participants
n=5 Participants
|
23 participants
n=7 Participants
|
28 participants
n=5 Participants
|
76 participants
n=4 Participants
|
|
Use of Proton Pump Inhibitor (PPI)
No
|
125 participants
n=5 Participants
|
128 participants
n=7 Participants
|
130 participants
n=5 Participants
|
383 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Approximately 2 weeks after invitation letter was sentPopulation: The analysis population for this outcome measure was the number of subjects per group who were eligible to contact.
This outcome measure was defined as the proportion of subjects who agreed to undergo esophageal assessment in the three groups out of those who were eligible to be contacted for participation in screening.
Outcome measures
| Measure |
Sedated Endoscopy
n=150 Participants
Sedated esophagogastroduodenoscopy with biopsy
Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl.
|
Transnasal Endoscopy at Hospital Unit
n=151 Participants
Unsedated transnasal endoscopy at hospital unit.
Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.
|
Transnasal Endoscopy at Mobile Unit
n=158 Participants
Unsedated transnasal endoscopy in mobile research van
Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.
|
|---|---|---|---|
|
Percentage of Subjects Who Agreed to Participated in the Esophageal Assessment
|
40.7 percentage of participants
|
45.7 percentage of participants
|
47.5 percentage of participants
|
SECONDARY outcome
Timeframe: Visit 1Population: The analysis population included all subjects who agreed to undergo the esophageal assessment (intent to treat).
The rate of successful intubation was defined as the ability to traverse the upper esophageal sphincter and visualize the esophageal mucosa and classified as successful or unsuccessful.
Outcome measures
| Measure |
Sedated Endoscopy
n=61 Participants
Sedated esophagogastroduodenoscopy with biopsy
Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl.
|
Transnasal Endoscopy at Hospital Unit
n=72 Participants
Unsedated transnasal endoscopy at hospital unit.
Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.
|
Transnasal Endoscopy at Mobile Unit
n=76 Participants
Unsedated transnasal endoscopy in mobile research van
Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.
|
|---|---|---|---|
|
Rate of Successful Intubation
|
100 percentage of participants
|
95.8 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Visit 1Population: The analysis population included all subjects who agreed to undergo the esophageal assessment (intent to treat).
The rate of complete evaluation was defined as visualization of the whole esophagus and identification of landmarks: squamocolumnar junction, gastroesophageal junction (upper margin of gastric folds with stomach deflated), and the diaphragmatic hiatus. The categories of evaluation were classified as complete (all three landmarks identified), incomplete (some landmarks identified), or unsuccessful.
Outcome measures
| Measure |
Sedated Endoscopy
n=61 Participants
Sedated esophagogastroduodenoscopy with biopsy
Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl.
|
Transnasal Endoscopy at Hospital Unit
n=72 Participants
Unsedated transnasal endoscopy at hospital unit.
Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.
|
Transnasal Endoscopy at Mobile Unit
n=76 Participants
Unsedated transnasal endoscopy in mobile research van
Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.
|
|---|---|---|---|
|
Rate of Complete Evaluation
Complete
|
61 procedures
|
69 procedures
|
75 procedures
|
|
Rate of Complete Evaluation
Incomplete
|
0 procedures
|
0 procedures
|
1 procedures
|
|
Rate of Complete Evaluation
Unsuccessful
|
0 procedures
|
3 procedures
|
0 procedures
|
SECONDARY outcome
Timeframe: Visit 1Population: The analysis population included all subjects who agreed to undergo the esophageal assessment (intent to treat).
Outcome measures
| Measure |
Sedated Endoscopy
n=61 Participants
Sedated esophagogastroduodenoscopy with biopsy
Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl.
|
Transnasal Endoscopy at Hospital Unit
n=72 Participants
Unsedated transnasal endoscopy at hospital unit.
Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.
|
Transnasal Endoscopy at Mobile Unit
n=76 Participants
Unsedated transnasal endoscopy in mobile research van
Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.
|
|---|---|---|---|
|
Rate of Acquisition of Biopsies From the Esophagus
Successful
|
100 percentage of participants
|
83.3 percentage of participants
|
79.0 percentage of participants
|
|
Rate of Acquisition of Biopsies From the Esophagus
Unsuccessful
|
0 percentage of participants
|
16.7 percentage of participants
|
21 percentage of participants
|
SECONDARY outcome
Timeframe: Visit 1Population: The analysis population included all subjects who agreed to undergo the esophageal assessment (intent to treat).
Duration of the procedure was defined as time from the beginning of the procedure (initiation of sedation or local anesthesia) to extubation.
Outcome measures
| Measure |
Sedated Endoscopy
n=61 Participants
Sedated esophagogastroduodenoscopy with biopsy
Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl.
|
Transnasal Endoscopy at Hospital Unit
n=72 Participants
Unsedated transnasal endoscopy at hospital unit.
Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.
|
Transnasal Endoscopy at Mobile Unit
n=76 Participants
Unsedated transnasal endoscopy in mobile research van
Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.
|
|---|---|---|---|
|
Mean Duration of Procedure
|
9.3 minutes
Standard Deviation 1.6
|
8.0 minutes
Standard Deviation 2.7
|
8.5 minutes
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Visit 1Population: The analysis population included all subjects who agreed to undergo the esophageal assessment (intent to treat).
This outcome measures the recovery time after the procedure.
Outcome measures
| Measure |
Sedated Endoscopy
n=61 Participants
Sedated esophagogastroduodenoscopy with biopsy
Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl.
|
Transnasal Endoscopy at Hospital Unit
n=72 Participants
Unsedated transnasal endoscopy at hospital unit.
Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.
|
Transnasal Endoscopy at Mobile Unit
n=76 Participants
Unsedated transnasal endoscopy in mobile research van
Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.
|
|---|---|---|---|
|
Mean Time From Extubation to Discharge
|
67.3 minutes
Standard Deviation 5.9
|
18.5 minutes
Standard Deviation 4.2
|
15.5 minutes
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: Day 1 after the procedurePopulation: The analysis population included all subjects who agreed to undergo the esophageal assessment (intent to treat).
Validated pain scales (where 0 is none and 10 is severe) were used to assess the degree of pain, choking, gagging, and anxiety experienced during the procedure. Overall tolerance was rated on a scale from 0 to 10, where 0 is good, and 10 is poor tolerance.
Outcome measures
| Measure |
Sedated Endoscopy
n=61 Participants
Sedated esophagogastroduodenoscopy with biopsy
Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl.
|
Transnasal Endoscopy at Hospital Unit
n=72 Participants
Unsedated transnasal endoscopy at hospital unit.
Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.
|
Transnasal Endoscopy at Mobile Unit
n=76 Participants
Unsedated transnasal endoscopy in mobile research van
Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.
|
|---|---|---|---|
|
Mean Tolerability Scores
Pain
|
0.1 units on a scale
Standard Deviation 0.5
|
2.7 units on a scale
Standard Deviation 2.3
|
3.2 units on a scale
Standard Deviation 8.8
|
|
Mean Tolerability Scores
Choking
|
0 units on a scale
Standard Deviation 0
|
0.8 units on a scale
Standard Deviation 1.8
|
0.6 units on a scale
Standard Deviation 1.9
|
|
Mean Tolerability Scores
Gagging
|
0.1 units on a scale
Standard Deviation 0.6
|
1.2 units on a scale
Standard Deviation 2.4
|
1.3 units on a scale
Standard Deviation 2.3
|
|
Mean Tolerability Scores
Anxiety
|
0.8 units on a scale
Standard Deviation 1.5
|
2.3 units on a scale
Standard Deviation 2.2
|
2.8 units on a scale
Standard Deviation 2.8
|
|
Mean Tolerability Scores
Overall Tolerance
|
0.4 units on a scale
Standard Deviation 0.6
|
2.2 units on a scale
Standard Deviation 2.2
|
1.9 units on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: Day 1 after the procedurePopulation: The analysis population included all subjects who agreed to undergo the esophageal assessment (intent to treat).
Acceptability was defined as the proportion of subjects willing to undergo the procedure again in the future.
Outcome measures
| Measure |
Sedated Endoscopy
n=61 Participants
Sedated esophagogastroduodenoscopy with biopsy
Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl.
|
Transnasal Endoscopy at Hospital Unit
n=72 Participants
Unsedated transnasal endoscopy at hospital unit.
Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.
|
Transnasal Endoscopy at Mobile Unit
n=76 Participants
Unsedated transnasal endoscopy in mobile research van
Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.
|
|---|---|---|---|
|
Acceptability
Unacceptable
|
6.6 percentage of participants
|
16.7 percentage of participants
|
21.1 percentage of participants
|
|
Acceptability
Acceptable
|
93.4 percentage of participants
|
83.3 percentage of participants
|
78.9 percentage of participants
|
Adverse Events
Sedated Endoscopy
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Transnasal Endoscopy at Hospital Unit
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Transnasal Endoscopy at Mobile Unit
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sedated Endoscopy
n=61 participants at risk
Sedated esophagogastroduodenoscopy with biopsy
Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl.
|
Transnasal Endoscopy at Hospital Unit
n=69 participants at risk
Unsedated transnasal endoscopy at hospital unit.
Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.
|
Transnasal Endoscopy at Mobile Unit
n=76 participants at risk
Unsedated transnasal endoscopy in mobile research van
Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.
|
|---|---|---|---|
|
General disorders
Sore Throat
|
13.1%
8/61 • Number of events 8 • 30 days after the procedure
All participants received a telephone call from the research coordinator 1 and 30 days after the procedure to complete adverse events questionnaires.
|
14.5%
10/69 • Number of events 10 • 30 days after the procedure
All participants received a telephone call from the research coordinator 1 and 30 days after the procedure to complete adverse events questionnaires.
|
15.8%
12/76 • Number of events 12 • 30 days after the procedure
All participants received a telephone call from the research coordinator 1 and 30 days after the procedure to complete adverse events questionnaires.
|
|
Gastrointestinal disorders
Bloating
|
3.3%
2/61 • Number of events 2 • 30 days after the procedure
All participants received a telephone call from the research coordinator 1 and 30 days after the procedure to complete adverse events questionnaires.
|
5.8%
4/69 • Number of events 4 • 30 days after the procedure
All participants received a telephone call from the research coordinator 1 and 30 days after the procedure to complete adverse events questionnaires.
|
3.9%
3/76 • Number of events 3 • 30 days after the procedure
All participants received a telephone call from the research coordinator 1 and 30 days after the procedure to complete adverse events questionnaires.
|
|
Blood and lymphatic system disorders
Epitaxis
|
0.00%
0/61 • 30 days after the procedure
All participants received a telephone call from the research coordinator 1 and 30 days after the procedure to complete adverse events questionnaires.
|
1.4%
1/69 • Number of events 1 • 30 days after the procedure
All participants received a telephone call from the research coordinator 1 and 30 days after the procedure to complete adverse events questionnaires.
|
1.3%
1/76 • Number of events 1 • 30 days after the procedure
All participants received a telephone call from the research coordinator 1 and 30 days after the procedure to complete adverse events questionnaires.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal pain
|
0.00%
0/61 • 30 days after the procedure
All participants received a telephone call from the research coordinator 1 and 30 days after the procedure to complete adverse events questionnaires.
|
0.00%
0/69 • 30 days after the procedure
All participants received a telephone call from the research coordinator 1 and 30 days after the procedure to complete adverse events questionnaires.
|
1.3%
1/76 • Number of events 1 • 30 days after the procedure
All participants received a telephone call from the research coordinator 1 and 30 days after the procedure to complete adverse events questionnaires.
|
|
General disorders
Abdominal/chest discomfort
|
6.6%
4/61 • Number of events 4 • 30 days after the procedure
All participants received a telephone call from the research coordinator 1 and 30 days after the procedure to complete adverse events questionnaires.
|
5.8%
4/69 • Number of events 4 • 30 days after the procedure
All participants received a telephone call from the research coordinator 1 and 30 days after the procedure to complete adverse events questionnaires.
|
2.6%
2/76 • Number of events 2 • 30 days after the procedure
All participants received a telephone call from the research coordinator 1 and 30 days after the procedure to complete adverse events questionnaires.
|
|
General disorders
Headache
|
0.00%
0/61 • 30 days after the procedure
All participants received a telephone call from the research coordinator 1 and 30 days after the procedure to complete adverse events questionnaires.
|
1.4%
1/69 • Number of events 1 • 30 days after the procedure
All participants received a telephone call from the research coordinator 1 and 30 days after the procedure to complete adverse events questionnaires.
|
5.3%
4/76 • Number of events 4 • 30 days after the procedure
All participants received a telephone call from the research coordinator 1 and 30 days after the procedure to complete adverse events questionnaires.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place