Trial Outcomes & Findings for Pilot Study to Image the Esophagus Using a SECM Tethered Endoscopic Capsule (NCT NCT02445014)
NCT ID: NCT02445014
Last Updated: 2020-08-21
Results Overview
The number of subjects from whom successful SECM imaging was obtained
COMPLETED
NA
3 participants
20 minute visit (5-7 minute imaging)
2020-08-21
Participant Flow
In this study we were trying to establish how many participants can provide us with quality imaging using this new technology. Therefore we treated them as one group. 2 healthy subjects and one with BE were enrolled. Upon reviewing imaging data it was concluded that this new technology is not optimal for the study and the enrollment was stopped.
Participant milestones
| Measure |
MGH SECM Imaging Capsule
Subject will swallow the SECM imaging capsule and images will be acquired using the SECM Imaging system.
MGH SECM Imaging Capsule: Imaging of the Esophagus using the SECM capsule and SECM Imaging system
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Study to Image the Esophagus Using a SECM Tethered Endoscopic Capsule
Baseline characteristics by cohort
| Measure |
MGH SECM Imaging Capsule
n=3 Participants
Subject will swallow the new large SECM imaging capsule and images will be acquired using the SECM Imaging system.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 20 minute visit (5-7 minute imaging)The number of subjects from whom successful SECM imaging was obtained
Outcome measures
| Measure |
MGH SECM Imaging Capsule
n=3 Participants
Subject will swallow the SECM imaging capsule and images will be acquired using the SECM Imaging system.
MGH SECM Imaging Capsule: Imaging of the Esophagus using the SECM capsule and SECM Imaging system
|
|---|---|
|
Feasibility for Imaging of Esophagus Using an SECM Tethered Endoscopic Capsule.
|
3 Participants
|
Adverse Events
MGH SECM Imaging Capsule
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