Trial Outcomes & Findings for Pilot Study for Imaging of the Esophagus Using Tethered Capsule OCT Endomicroscopy With Distal Scanning (NCT NCT02947997)
NCT ID: NCT02947997
Last Updated: 2023-01-17
Results Overview
An investigator to assess the quality of the recorded images obtained with each exam after imaging has been completed
Recruitment status
COMPLETED
Target enrollment
4 participants
Primary outcome timeframe
Approximate 20 minute visit (5 min image acquisition)
Results posted on
2023-01-17
Participant Flow
No significant events occurred after participants enrollment.
Participant milestones
| Measure |
OFDI Capsule Imaging
Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI imaging system.
OFDI capsule: Imaging of esophagus using OFDI capsule and system
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Study for Imaging of the Esophagus Using Tethered Capsule OCT Endomicroscopy With Distal Scanning
Baseline characteristics by cohort
| Measure |
OFDI Capsule Imaging
n=4 Participants
Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI imaging system
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
24.5 years
STANDARD_DEVIATION 5.06 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Approximate 20 minute visit (5 min image acquisition)An investigator to assess the quality of the recorded images obtained with each exam after imaging has been completed
Outcome measures
| Measure |
OFDI Capsule Imaging
n=4 Participants
Subjects who swallowed the OFDI capsule and good quality imaging was acquired using the OFDI imaging system.
|
|---|---|
|
Number of Participants For Whom Good Quality Images Were Recorded After Swallowing The OFDI Capsule
|
3 Participants
|
Adverse Events
OFDI Capsule Imaging
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place