Trial Outcomes & Findings for Treatment of Field Cancerization for Reduction in Tumor Burden - A Prospective Study (NCT NCT02150863)
NCT ID: NCT02150863
Last Updated: 2019-11-18
Results Overview
This is done at every visit over the 3 year period
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
1 participants
Primary outcome timeframe
Entire study period (3 years)
Results posted on
2019-11-18
Participant Flow
Participant milestones
| Measure |
Ultrapulse Laser Alone
Ultrapulse Carbon Dioxide Laser
|
Ultrapulse Laser Plus Cellutome Harvesting System
Ultrapulse Carbon Dioxide Laser
Cellutome epidermal harvesting system
|
Control
Control group, no treatment
|
|---|---|---|---|
|
Overall Study
STARTED
|
0
|
1
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Ultrapulse Laser Alone
Ultrapulse Carbon Dioxide Laser
|
Ultrapulse Laser Plus Cellutome Harvesting System
Ultrapulse Carbon Dioxide Laser
Cellutome epidermal harvesting system
|
Control
Control group, no treatment
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
Baseline Characteristics
Treatment of Field Cancerization for Reduction in Tumor Burden - A Prospective Study
Baseline characteristics by cohort
| Measure |
Ultrapulse Laser Alone
Ultrapulse Carbon Dioxide Laser
|
Ultrapulse Laser Plus Cellutome Harvesting System
n=1 Participants
Ultrapulse Carbon Dioxide Laser
Cellutome epidermal harvesting system
|
Control
Control group
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
—
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
—
|
0 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
—
|
1 Participants
n=7 Participants
|
|
Age, Continuous
|
—
|
70 years
n=107 Participants
|
—
|
70 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
—
|
1 Participants
n=107 Participants
|
—
|
1 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
—
|
0 Participants
n=107 Participants
|
—
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
—
|
0 Participants
n=107 Participants
|
—
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
—
|
1 Participants
n=107 Participants
|
—
|
1 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
—
|
0 Participants
n=107 Participants
|
—
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
—
|
1 Participants
n=107 Participants
|
—
|
1 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Entire study period (3 years)Population: Zero participants were analyzed because no patients finished this study. Patient recruitment was very difficult for this study, and therefore the study ended prematurely.
This is done at every visit over the 3 year period
Outcome measures
Outcome data not reported
Adverse Events
Ultrapulse Laser Alone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ultrapulse Laser Plus Cellutome Harvesting System
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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
Elizabeth Morehouse, Clinical Research Coordinator
Massachusetts General Hospital
Phone: 617-724-2168
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place