Trial Outcomes & Findings for WallFlex Esophageal Fully Covered (FC) Benign Anastomotic Stricture (NCT NCT01699542)
NCT ID: NCT01699542
Last Updated: 2021-06-28
Results Overview
Number of dilation procedures for the management of dysphagia within 12 months following initial study treatment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
12 months
Results posted on
2021-06-28
Participant Flow
Participant milestones
| Measure |
Metal Stent
The WallFlex Biliary Fully Covered Esophageal Stent System is being evaluated for treatment of refractory anastomotic esophageal strictures.
WallFlex Esophageal RX Fully Covered Stent: Temporary placement of the WallFlex Esophageal RX Fully Covered Stent for treatment of refractory anastomotic esophageal strictures. The stent will be removed after 8 weeks (plus or minus 7 days) indwell
|
Bougie Dilation
Esophageal Bougie Dilator commercially available devices used per Investigator preference are being evaluated for treatment of refractory anastomotic esophageal strictures.
Esophageal Bougie Dilator Per Investigator preference: Commercially available Esophageal Bougie Dilator Per Investigator preference
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
|
Overall Study
COMPLETED
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Metal Stent
n=9 Participants
The WallFlex Biliary Fully Covered Esophageal Stent System is being evaluated for treatment of refractory anastomotic esophageal strictures.
WallFlex Esophageal RX Fully Covered Stent: Temporary placement of the WallFlex Esophageal RX Fully Covered Stent for treatment of refractory anastomotic esophageal strictures. The stent will be removed after 8 weeks (plus or minus 7 days) indwell
|
Bougie Dilation
n=9 Participants
Esophageal Bougie Dilator commercially available devices used per Investigator preference are being evaluated for treatment of refractory anastomotic esophageal strictures.
Esophageal Bougie Dilator Per Investigator preference: Commercially available Esophageal Bougie Dilator Per Investigator preference
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.6 years
STANDARD_DEVIATION 6.3 • n=9 Participants
|
66.6 years
STANDARD_DEVIATION 7.7 • n=9 Participants
|
66.6 years
STANDARD_DEVIATION 6.9 • n=18 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=9 Participants
|
3 Participants
n=9 Participants
|
6 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=9 Participants
|
6 Participants
n=9 Participants
|
12 Participants
n=18 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Type of Esophagectomy
Transthoracic
|
6 Participants
n=9 Participants
|
8 Participants
n=9 Participants
|
14 Participants
n=18 Participants
|
|
Type of Esophagectomy
Transhiatal
|
3 Participants
n=9 Participants
|
1 Participants
n=9 Participants
|
4 Participants
n=18 Participants
|
|
Maximum Dilation
|
16.4 mm
STANDARD_DEVIATION 0.9 • n=9 Participants
|
15.9 mm
STANDARD_DEVIATION 2.0 • n=9 Participants
|
16.2 mm
STANDARD_DEVIATION 1.5 • n=18 Participants
|
|
Dysphagia Score
Dysphagia Score = 2
|
6 Participants
n=9 Participants
|
9 Participants
n=9 Participants
|
15 Participants
n=18 Participants
|
|
Dysphagia Score
Dysphagia Score > 2
|
3 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
3 Participants
n=18 Participants
|
|
Number of Pretreatment Dilations
|
2.0 Pretreatment Dilations
STANDARD_DEVIATION 0.0 • n=9 Participants
|
2.4 Pretreatment Dilations
STANDARD_DEVIATION 1.0 • n=9 Participants
|
2.2 Pretreatment Dilations
STANDARD_DEVIATION 0.7 • n=18 Participants
|
|
Quality of Life Overall Health Score
|
65.0 units on a scale
n=9 Participants
|
80.0 units on a scale
n=9 Participants
|
70.0 units on a scale
n=18 Participants
|
PRIMARY outcome
Timeframe: 12 monthsNumber of dilation procedures for the management of dysphagia within 12 months following initial study treatment.
Outcome measures
| Measure |
Metal Stent
n=9 Participants
The WallFlex Biliary Fully Covered Esophageal Stent System is being evaluated for treatment of refractory anastomotic esophageal strictures.
WallFlex Esophageal RX Fully Covered Stent: Temporary placement of the WallFlex Esophageal RX Fully Covered Stent for treatment of refractory anastomotic esophageal strictures. The stent will be removed after 8 weeks (plus or minus 7 days) indwell
|
Bougie Dilation
n=9 Participants
Esophageal Bougie Dilator commercially available devices used per Investigator preference are being evaluated for treatment of refractory anastomotic esophageal strictures.
Esophageal Bougie Dilator Per Investigator preference: Commercially available Esophageal Bougie Dilator Per Investigator preference
|
|---|---|---|
|
Number of Dilation Procedures
|
5.4 Dilation procedures
Standard Deviation 5.4
|
2.4 Dilation procedures
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Outcome measure only applicable to participants in the Metal Stent arm, as only participants in the Metal Stent arm received a stent. Participants in the Bougie Dilation arm did not receive a stent and therefore there is no data to collect regarding technical success of stent placement for the Bougie arm.
Technical stent placement success is defined as the ability to deploy the stent in satisfactory position across the stricture.
Outcome measures
| Measure |
Metal Stent
n=9 Participants
The WallFlex Biliary Fully Covered Esophageal Stent System is being evaluated for treatment of refractory anastomotic esophageal strictures.
WallFlex Esophageal RX Fully Covered Stent: Temporary placement of the WallFlex Esophageal RX Fully Covered Stent for treatment of refractory anastomotic esophageal strictures. The stent will be removed after 8 weeks (plus or minus 7 days) indwell
|
Bougie Dilation
Esophageal Bougie Dilator commercially available devices used per Investigator preference are being evaluated for treatment of refractory anastomotic esophageal strictures.
Esophageal Bougie Dilator Per Investigator preference: Commercially available Esophageal Bougie Dilator Per Investigator preference
|
|---|---|---|
|
Number of Participants With Technical Stent Placement Success
|
9 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Outcome measure only applicable to participants in the Metal Stent arm, as only participants in the Metal Stent arm received a stent and therefore underwent stent removal. Participants in the Bougie Dilation arm did not receive a stent and therefore there is no data to collect regarding technical success of stent removal for the Bougie arm.
Technical stent removal success is defined as the ability to remove the stent without complications.
Outcome measures
| Measure |
Metal Stent
n=9 Participants
The WallFlex Biliary Fully Covered Esophageal Stent System is being evaluated for treatment of refractory anastomotic esophageal strictures.
WallFlex Esophageal RX Fully Covered Stent: Temporary placement of the WallFlex Esophageal RX Fully Covered Stent for treatment of refractory anastomotic esophageal strictures. The stent will be removed after 8 weeks (plus or minus 7 days) indwell
|
Bougie Dilation
Esophageal Bougie Dilator commercially available devices used per Investigator preference are being evaluated for treatment of refractory anastomotic esophageal strictures.
Esophageal Bougie Dilator Per Investigator preference: Commercially available Esophageal Bougie Dilator Per Investigator preference
|
|---|---|---|
|
Number of Participants With Technical Stent Removal Success
|
9 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 2, Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, and Month 12Patient's satisfaction with the therapy (scored by a visual analog scale) assessed at day 2, week 2, month 1, month 2, month 3, month 6, month 9, and month 12. Patient Satisfaction with Therapy scale ranges from 0-10. The minimum on this scale is 0 (0 being completely unsatisfied with the therapy; a worse outcome) and the maximum on this scale is 10 (10 being completely satisfied with the therapy; a better outcome).
Outcome measures
| Measure |
Metal Stent
n=9 Participants
The WallFlex Biliary Fully Covered Esophageal Stent System is being evaluated for treatment of refractory anastomotic esophageal strictures.
WallFlex Esophageal RX Fully Covered Stent: Temporary placement of the WallFlex Esophageal RX Fully Covered Stent for treatment of refractory anastomotic esophageal strictures. The stent will be removed after 8 weeks (plus or minus 7 days) indwell
|
Bougie Dilation
n=9 Participants
Esophageal Bougie Dilator commercially available devices used per Investigator preference are being evaluated for treatment of refractory anastomotic esophageal strictures.
Esophageal Bougie Dilator Per Investigator preference: Commercially available Esophageal Bougie Dilator Per Investigator preference
|
|---|---|---|
|
Patient's Satisfaction With the Therapy
Day 2
|
8.0 score on a scale
Interval 7.0 to 8.0
|
10.0 score on a scale
Interval 8.0 to 10.0
|
|
Patient's Satisfaction With the Therapy
Week 2
|
8.0 score on a scale
Interval 8.0 to 9.0
|
9.5 score on a scale
Interval 7.0 to 10.0
|
|
Patient's Satisfaction With the Therapy
Month 1
|
9.0 score on a scale
Interval 8.0 to 9.0
|
10.0 score on a scale
Interval 6.0 to 10.0
|
|
Patient's Satisfaction With the Therapy
Month 2
|
9.0 score on a scale
Interval 8.0 to 10.0
|
8.0 score on a scale
Interval 8.0 to 10.0
|
|
Patient's Satisfaction With the Therapy
Month 3
|
8.0 score on a scale
Interval 8.0 to 9.0
|
8.0 score on a scale
Interval 8.0 to 10.0
|
|
Patient's Satisfaction With the Therapy
Month 6
|
8.0 score on a scale
Interval 8.0 to 9.0
|
9.0 score on a scale
Interval 8.0 to 10.0
|
|
Patient's Satisfaction With the Therapy
Month 9
|
9.5 score on a scale
Interval 7.5 to 10.0
|
9.0 score on a scale
Interval 7.0 to 10.0
|
|
Patient's Satisfaction With the Therapy
Month 12
|
9.0 score on a scale
Interval 7.5 to 10.0
|
10.0 score on a scale
Interval 8.0 to 10.0
|
SECONDARY outcome
Timeframe: Baseline, Day 2, Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, and Month 12Patient's report of pain (scored by a visual analog scale) assessed at Baseline, day 2, week 2, month 1, month 2, month 3, month 6, month 9, and month 12. Pain Numerical Rating Scale ranges from 0-10. The minimum on this scale is 0 (0 being no pain; a better outcome) and the maximum on this scale is 10 (10 being worst pain ever; a worse outcome).
Outcome measures
| Measure |
Metal Stent
n=9 Participants
The WallFlex Biliary Fully Covered Esophageal Stent System is being evaluated for treatment of refractory anastomotic esophageal strictures.
WallFlex Esophageal RX Fully Covered Stent: Temporary placement of the WallFlex Esophageal RX Fully Covered Stent for treatment of refractory anastomotic esophageal strictures. The stent will be removed after 8 weeks (plus or minus 7 days) indwell
|
Bougie Dilation
n=9 Participants
Esophageal Bougie Dilator commercially available devices used per Investigator preference are being evaluated for treatment of refractory anastomotic esophageal strictures.
Esophageal Bougie Dilator Per Investigator preference: Commercially available Esophageal Bougie Dilator Per Investigator preference
|
|---|---|---|
|
Patient's Report of Pain
Baseline
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 2.0
|
|
Patient's Report of Pain
Day 2
|
3.0 score on a scale
Interval 1.0 to 4.0
|
0.0 score on a scale
Interval 0.0 to 2.0
|
|
Patient's Report of Pain
Week 2
|
1.0 score on a scale
Interval 0.0 to 4.0
|
0.0 score on a scale
Interval 0.0 to 1.0
|
|
Patient's Report of Pain
Month 1
|
0.0 score on a scale
Interval 0.0 to 1.0
|
0.0 score on a scale
Interval 0.0 to 1.0
|
|
Patient's Report of Pain
Month 2
|
0.0 score on a scale
Interval 0.0 to 2.0
|
0.0 score on a scale
Interval 0.0 to 1.0
|
|
Patient's Report of Pain
Month 3
|
0.0 score on a scale
Interval 0.0 to 2.0
|
0.0 score on a scale
Interval 0.0 to 1.0
|
|
Patient's Report of Pain
Month 6
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
|
Patient's Report of Pain
Month 9
|
0.0 score on a scale
Interval 0.0 to 1.5
|
0.0 score on a scale
Interval 0.0 to 0.0
|
|
Patient's Report of Pain
Month 12
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 2, Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, and Month 12Quality of life scale measuring overall health score assessed at day 2, week 2, month 1, month 2, month 3, month 6, month 9, and month 12. The scale is numbered from 0 to 100. 0 is the worst health the participant can imagine. 100 is the best health the participant can imagine. A lower score indicates a worse outcome. A higher score indicates a better outcome.
Outcome measures
| Measure |
Metal Stent
n=9 Participants
The WallFlex Biliary Fully Covered Esophageal Stent System is being evaluated for treatment of refractory anastomotic esophageal strictures.
WallFlex Esophageal RX Fully Covered Stent: Temporary placement of the WallFlex Esophageal RX Fully Covered Stent for treatment of refractory anastomotic esophageal strictures. The stent will be removed after 8 weeks (plus or minus 7 days) indwell
|
Bougie Dilation
n=9 Participants
Esophageal Bougie Dilator commercially available devices used per Investigator preference are being evaluated for treatment of refractory anastomotic esophageal strictures.
Esophageal Bougie Dilator Per Investigator preference: Commercially available Esophageal Bougie Dilator Per Investigator preference
|
|---|---|---|
|
Quality Of Life Overall Health Score
Day 2
|
70.0 score on a scale
Interval 65.0 to 75.0
|
75.0 score on a scale
Interval 70.0 to 80.0
|
|
Quality Of Life Overall Health Score
Week 2
|
70.0 score on a scale
Interval 70.0 to 75.0
|
80.0 score on a scale
Interval 60.0 to 80.0
|
|
Quality Of Life Overall Health Score
Month 1
|
80.0 score on a scale
Interval 75.0 to 85.0
|
80.0 score on a scale
Interval 70.0 to 90.0
|
|
Quality Of Life Overall Health Score
Month 2
|
80.0 score on a scale
Interval 75.0 to 80.0
|
77.5 score on a scale
Interval 56.0 to 87.5
|
|
Quality Of Life Overall Health Score
Month 3
|
75.0 score on a scale
Interval 60.0 to 85.0
|
85.0 score on a scale
Interval 70.0 to 90.0
|
|
Quality Of Life Overall Health Score
Month 6
|
67.5 score on a scale
Interval 62.5 to 75.0
|
85.0 score on a scale
Interval 60.0 to
|
|
Quality Of Life Overall Health Score
Month 9
|
70.0 score on a scale
Interval 62.5 to 80.0
|
80.0 score on a scale
Interval 70.0 to 90.0
|
|
Quality Of Life Overall Health Score
Month 12
|
75.0 score on a scale
Interval 67.5 to 85.0
|
70.0 score on a scale
Interval 70.0 to 90.0
|
SECONDARY outcome
Timeframe: 12 monthsOccurrence and severity of adverse events related to the stent/bougie dilator and/or the procedure.
Outcome measures
| Measure |
Metal Stent
n=9 Participants
The WallFlex Biliary Fully Covered Esophageal Stent System is being evaluated for treatment of refractory anastomotic esophageal strictures.
WallFlex Esophageal RX Fully Covered Stent: Temporary placement of the WallFlex Esophageal RX Fully Covered Stent for treatment of refractory anastomotic esophageal strictures. The stent will be removed after 8 weeks (plus or minus 7 days) indwell
|
Bougie Dilation
n=9 Participants
Esophageal Bougie Dilator commercially available devices used per Investigator preference are being evaluated for treatment of refractory anastomotic esophageal strictures.
Esophageal Bougie Dilator Per Investigator preference: Commercially available Esophageal Bougie Dilator Per Investigator preference
|
|---|---|---|
|
Occurrence and Severity of Adverse Events Related to the Stent/Bougie Dilator and/or the Procedure
Related Serious Adverse Events
|
1 Participants
|
0 Participants
|
|
Occurrence and Severity of Adverse Events Related to the Stent/Bougie Dilator and/or the Procedure
Related Non-serious Adverse Events
|
5 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 monthsTime to recurrence of dysphagia, defined as inability of a normal diameter gastroscope (9.8mm) to pass the stricture.
Outcome measures
| Measure |
Metal Stent
n=9 Participants
The WallFlex Biliary Fully Covered Esophageal Stent System is being evaluated for treatment of refractory anastomotic esophageal strictures.
WallFlex Esophageal RX Fully Covered Stent: Temporary placement of the WallFlex Esophageal RX Fully Covered Stent for treatment of refractory anastomotic esophageal strictures. The stent will be removed after 8 weeks (plus or minus 7 days) indwell
|
Bougie Dilation
n=9 Participants
Esophageal Bougie Dilator commercially available devices used per Investigator preference are being evaluated for treatment of refractory anastomotic esophageal strictures.
Esophageal Bougie Dilator Per Investigator preference: Commercially available Esophageal Bougie Dilator Per Investigator preference
|
|---|---|---|
|
Time to Recurrence of Dysphagia
|
36 Days
Interval 24.0 to 71.0
|
33 Days
Interval 21.0 to 33.0
|
SECONDARY outcome
Timeframe: 12 monthsTotal number of stent migrations with or without symptoms.
Outcome measures
| Measure |
Metal Stent
n=9 Participants
The WallFlex Biliary Fully Covered Esophageal Stent System is being evaluated for treatment of refractory anastomotic esophageal strictures.
WallFlex Esophageal RX Fully Covered Stent: Temporary placement of the WallFlex Esophageal RX Fully Covered Stent for treatment of refractory anastomotic esophageal strictures. The stent will be removed after 8 weeks (plus or minus 7 days) indwell
|
Bougie Dilation
n=9 Participants
Esophageal Bougie Dilator commercially available devices used per Investigator preference are being evaluated for treatment of refractory anastomotic esophageal strictures.
Esophageal Bougie Dilator Per Investigator preference: Commercially available Esophageal Bougie Dilator Per Investigator preference
|
|---|---|---|
|
Total Number of Stent Migrations
|
2 stent migrations
|
0 stent migrations
|
SECONDARY outcome
Timeframe: 12 monthsNumber of reinterventions within 12 months following the initial study treatment.
Outcome measures
| Measure |
Metal Stent
n=9 Participants
The WallFlex Biliary Fully Covered Esophageal Stent System is being evaluated for treatment of refractory anastomotic esophageal strictures.
WallFlex Esophageal RX Fully Covered Stent: Temporary placement of the WallFlex Esophageal RX Fully Covered Stent for treatment of refractory anastomotic esophageal strictures. The stent will be removed after 8 weeks (plus or minus 7 days) indwell
|
Bougie Dilation
n=9 Participants
Esophageal Bougie Dilator commercially available devices used per Investigator preference are being evaluated for treatment of refractory anastomotic esophageal strictures.
Esophageal Bougie Dilator Per Investigator preference: Commercially available Esophageal Bougie Dilator Per Investigator preference
|
|---|---|---|
|
Number of Reinterventions Within 12 Months Following the Initial Study Treatment
|
5.6 reinterventions
Standard Deviation 5.3
|
2.9 reinterventions
Standard Deviation 2.7
|
Adverse Events
Metal Stent
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Bougie Dilation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Metal Stent
n=9 participants at risk
The WallFlex Biliary Fully Covered Esophageal Stent System is being evaluated for treatment of refractory anastomotic esophageal strictures.
WallFlex Esophageal RX Fully Covered Stent: Temporary placement of the WallFlex Esophageal RX Fully Covered Stent for treatment of refractory anastomotic esophageal strictures. The stent will be removed after 8 weeks (plus or minus 7 days) indwell
|
Bougie Dilation
n=9 participants at risk
Esophageal Bougie Dilator commercially available devices used per Investigator preference are being evaluated for treatment of refractory anastomotic esophageal strictures.
Esophageal Bougie Dilator Per Investigator preference: Commercially available Esophageal Bougie Dilator Per Investigator preference
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
11.1%
1/9 • Number of events 1 • Adverse event data collected for events related to the stent/bougie dilator and/or the procedure, from the time the participant signed the informed consent and was randomized to the study, until completion of the 12 month follow-up visit (occurring 12 months post-initial study treatment).
Collected and reported only on those Adverse Events (Serious and Non-serious) related to the stent/bougie dilator and/or the procedure.
|
0.00%
0/9 • Adverse event data collected for events related to the stent/bougie dilator and/or the procedure, from the time the participant signed the informed consent and was randomized to the study, until completion of the 12 month follow-up visit (occurring 12 months post-initial study treatment).
Collected and reported only on those Adverse Events (Serious and Non-serious) related to the stent/bougie dilator and/or the procedure.
|
Other adverse events
| Measure |
Metal Stent
n=9 participants at risk
The WallFlex Biliary Fully Covered Esophageal Stent System is being evaluated for treatment of refractory anastomotic esophageal strictures.
WallFlex Esophageal RX Fully Covered Stent: Temporary placement of the WallFlex Esophageal RX Fully Covered Stent for treatment of refractory anastomotic esophageal strictures. The stent will be removed after 8 weeks (plus or minus 7 days) indwell
|
Bougie Dilation
n=9 participants at risk
Esophageal Bougie Dilator commercially available devices used per Investigator preference are being evaluated for treatment of refractory anastomotic esophageal strictures.
Esophageal Bougie Dilator Per Investigator preference: Commercially available Esophageal Bougie Dilator Per Investigator preference
|
|---|---|---|
|
Gastrointestinal disorders
Recurrent Dysphagia
|
11.1%
1/9 • Number of events 1 • Adverse event data collected for events related to the stent/bougie dilator and/or the procedure, from the time the participant signed the informed consent and was randomized to the study, until completion of the 12 month follow-up visit (occurring 12 months post-initial study treatment).
Collected and reported only on those Adverse Events (Serious and Non-serious) related to the stent/bougie dilator and/or the procedure.
|
0.00%
0/9 • Adverse event data collected for events related to the stent/bougie dilator and/or the procedure, from the time the participant signed the informed consent and was randomized to the study, until completion of the 12 month follow-up visit (occurring 12 months post-initial study treatment).
Collected and reported only on those Adverse Events (Serious and Non-serious) related to the stent/bougie dilator and/or the procedure.
|
|
Gastrointestinal disorders
Epigastric Pain
|
11.1%
1/9 • Number of events 1 • Adverse event data collected for events related to the stent/bougie dilator and/or the procedure, from the time the participant signed the informed consent and was randomized to the study, until completion of the 12 month follow-up visit (occurring 12 months post-initial study treatment).
Collected and reported only on those Adverse Events (Serious and Non-serious) related to the stent/bougie dilator and/or the procedure.
|
0.00%
0/9 • Adverse event data collected for events related to the stent/bougie dilator and/or the procedure, from the time the participant signed the informed consent and was randomized to the study, until completion of the 12 month follow-up visit (occurring 12 months post-initial study treatment).
Collected and reported only on those Adverse Events (Serious and Non-serious) related to the stent/bougie dilator and/or the procedure.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux
|
11.1%
1/9 • Number of events 1 • Adverse event data collected for events related to the stent/bougie dilator and/or the procedure, from the time the participant signed the informed consent and was randomized to the study, until completion of the 12 month follow-up visit (occurring 12 months post-initial study treatment).
Collected and reported only on those Adverse Events (Serious and Non-serious) related to the stent/bougie dilator and/or the procedure.
|
0.00%
0/9 • Adverse event data collected for events related to the stent/bougie dilator and/or the procedure, from the time the participant signed the informed consent and was randomized to the study, until completion of the 12 month follow-up visit (occurring 12 months post-initial study treatment).
Collected and reported only on those Adverse Events (Serious and Non-serious) related to the stent/bougie dilator and/or the procedure.
|
|
General disorders
Foreign Body Sensation
|
11.1%
1/9 • Number of events 1 • Adverse event data collected for events related to the stent/bougie dilator and/or the procedure, from the time the participant signed the informed consent and was randomized to the study, until completion of the 12 month follow-up visit (occurring 12 months post-initial study treatment).
Collected and reported only on those Adverse Events (Serious and Non-serious) related to the stent/bougie dilator and/or the procedure.
|
0.00%
0/9 • Adverse event data collected for events related to the stent/bougie dilator and/or the procedure, from the time the participant signed the informed consent and was randomized to the study, until completion of the 12 month follow-up visit (occurring 12 months post-initial study treatment).
Collected and reported only on those Adverse Events (Serious and Non-serious) related to the stent/bougie dilator and/or the procedure.
|
|
Gastrointestinal disorders
Retching due to Foreign Body Sensation
|
11.1%
1/9 • Number of events 1 • Adverse event data collected for events related to the stent/bougie dilator and/or the procedure, from the time the participant signed the informed consent and was randomized to the study, until completion of the 12 month follow-up visit (occurring 12 months post-initial study treatment).
Collected and reported only on those Adverse Events (Serious and Non-serious) related to the stent/bougie dilator and/or the procedure.
|
0.00%
0/9 • Adverse event data collected for events related to the stent/bougie dilator and/or the procedure, from the time the participant signed the informed consent and was randomized to the study, until completion of the 12 month follow-up visit (occurring 12 months post-initial study treatment).
Collected and reported only on those Adverse Events (Serious and Non-serious) related to the stent/bougie dilator and/or the procedure.
|
|
General disorders
Thoracic Pain
|
11.1%
1/9 • Number of events 1 • Adverse event data collected for events related to the stent/bougie dilator and/or the procedure, from the time the participant signed the informed consent and was randomized to the study, until completion of the 12 month follow-up visit (occurring 12 months post-initial study treatment).
Collected and reported only on those Adverse Events (Serious and Non-serious) related to the stent/bougie dilator and/or the procedure.
|
0.00%
0/9 • Adverse event data collected for events related to the stent/bougie dilator and/or the procedure, from the time the participant signed the informed consent and was randomized to the study, until completion of the 12 month follow-up visit (occurring 12 months post-initial study treatment).
Collected and reported only on those Adverse Events (Serious and Non-serious) related to the stent/bougie dilator and/or the procedure.
|
|
Musculoskeletal and connective tissue disorders
Cervical Pain
|
11.1%
1/9 • Number of events 1 • Adverse event data collected for events related to the stent/bougie dilator and/or the procedure, from the time the participant signed the informed consent and was randomized to the study, until completion of the 12 month follow-up visit (occurring 12 months post-initial study treatment).
Collected and reported only on those Adverse Events (Serious and Non-serious) related to the stent/bougie dilator and/or the procedure.
|
0.00%
0/9 • Adverse event data collected for events related to the stent/bougie dilator and/or the procedure, from the time the participant signed the informed consent and was randomized to the study, until completion of the 12 month follow-up visit (occurring 12 months post-initial study treatment).
Collected and reported only on those Adverse Events (Serious and Non-serious) related to the stent/bougie dilator and/or the procedure.
|
Additional Information
Joyce Peetermans, PhD - Vice President, Global Clinical Programs
Boston Scientific Corporation
Phone: 508-683-4211
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60