Trial Outcomes & Findings for Capsule Endoscopy for Post-Ablation Esophageal Lesion Assessment (NCT NCT00990782)
NCT ID: NCT00990782
Last Updated: 2017-07-02
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
93 participants
Primary outcome timeframe
14 days
Results posted on
2017-07-02
Participant Flow
Participant milestones
| Measure |
PillCam ESO Capsule Endoscope
All patients receive capsule endoscopy before and after RFA procedure.
PillCam ESO Capsule Endoscope: Utilization of the PillCam ESO capsule endoscope to evaluate the condition of a patient's esophagus before and after RFA therapy to treat atrial fibrillation.
|
|---|---|
|
Overall Study
STARTED
|
93
|
|
Overall Study
COMPLETED
|
88
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Capsule Endoscopy for Post-Ablation Esophageal Lesion Assessment
Baseline characteristics by cohort
| Measure |
PillCam ESO Capsule Endoscope
n=88 Participants
All patients receive capsule endoscopy before and after RFA procedure.
PillCam ESO Capsule Endoscope: Utilization of the PillCam ESO capsule endoscope to evaluate the condition of a patient's esophagus before and after RFA therapy to treat atrial fibrillation.
|
|---|---|
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Age, Continuous
|
59.5 Years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
88 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 daysOutcome measures
| Measure |
PillCam ESO Capsule Endoscope
n=88 Participants
All patients receive capsule endoscopy before and after RFA procedure.
PillCam ESO Capsule Endoscope: Utilization of the PillCam ESO capsule endoscope to evaluate the condition of a patient's esophagus before and after RFA therapy to treat atrial fibrillation.
|
|---|---|
|
Number of Participants With Esophageal Lesions Identified Using Capsule Endoscopy
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15 Participants
|
SECONDARY outcome
Timeframe: 14 DaysOutcome measures
| Measure |
PillCam ESO Capsule Endoscope
n=15 Participants
All patients receive capsule endoscopy before and after RFA procedure.
PillCam ESO Capsule Endoscope: Utilization of the PillCam ESO capsule endoscope to evaluate the condition of a patient's esophagus before and after RFA therapy to treat atrial fibrillation.
|
|---|---|
|
Number of Participants With Capsule-identified Esophageal Injury Who Report Symptoms Post-RFA
|
6 Participants
|
Adverse Events
PillCam ESO Capsule Endoscope
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PillCam ESO Capsule Endoscope
n=88 participants at risk
All patients receive capsule endoscopy before and after RFA procedure.
PillCam ESO Capsule Endoscope: Utilization of the PillCam ESO capsule endoscope to evaluate the condition of a patient's esophagus before and after RFA therapy to treat atrial fibrillation.
|
|---|---|
|
General disorders
Chest Discomfort
|
22.7%
20/88 • 3 Months
|
|
General disorders
Throat Pain
|
4.5%
4/88 • 3 Months
|
|
Gastrointestinal disorders
Nausea
|
9.1%
8/88 • 3 Months
|
|
General disorders
Abdominal Pain
|
1.1%
1/88 • 3 Months
|
|
General disorders
Fever
|
6.8%
6/88 • 3 Months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place