Trial Outcomes & Findings for Optical Frequency Domain Imaging (OFDI) for Biliary Stricture Imaging (NCT NCT01439620)
NCT ID: NCT01439620
Last Updated: 2019-04-10
Results Overview
The number of subjects in which the performed OFDI imaging visualizes common bile duct and common hepatic duct strictures.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
7 participants
Primary outcome timeframe
day 1, during diagnostic procedure
Results posted on
2019-04-10
Participant Flow
Participant milestones
| Measure |
OFDI Imaging
Subject will swallow an OFDI capsule and images will be obtained using MGH Optical Frequency Domain Imaging (OFDI) imaging system.
MGH Optical Frequency Domain Imaging (OFDI): Imaging of biliary tract with OFDI system using MGH Optical Frequency Domain Imaging (OFDI) System
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|---|---|
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Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Optical Frequency Domain Imaging (OFDI) for Biliary Stricture Imaging
Baseline characteristics by cohort
| Measure |
OFDI Imaging
n=7 Participants
Subject will swallow an OFDI capsule and images will be obtained using MGH Optical Frequency Domain Imaging (OFDI) imaging system.
MGH Optical Frequency Domain Imaging (OFDI): Imaging of biliary tract with OFDI system using MGH Optical Frequency Domain Imaging (OFDI) System
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|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 11.24 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: day 1, during diagnostic procedurePopulation: Seven subjects were enrolled and imaged in this study
The number of subjects in which the performed OFDI imaging visualizes common bile duct and common hepatic duct strictures.
Outcome measures
| Measure |
Optical Frequency Domain Imaging (OFDI Imaging
n=7 Participants
Subject will swallow an OFDI capsule and images will be obtained using MGH Optical Frequency Domain Imaging (OFDI) imaging system.
MGH Optical Frequency Domain Imaging (OFDI): Imaging of biliary tract with OFDI system using MGH Optical Frequency Domain Imaging (OFDI) System
|
|---|---|
|
Feasibility of Imaging the Bile Duct With the OFDI Probe
|
7 Participants
|
Adverse Events
OFDI 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
Gary Tearney, MD
Massachusetts General Hospital
Phone: Optical Frequency Domain Imagi
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place