Trial Outcomes & Findings for Spray Cryotherapy for Esophageal Cancer (ICE-CANCER) (NCT NCT01868139)
NCT ID: NCT01868139
Last Updated: 2022-03-07
Results Overview
The primary endpoint is to determine the response rate to spray cryotherapy. It is hypothesized that one of the two following outcomes will occur: 1. Complete response to therapy: complete tumor eradication confirmed through histologic examination of biopsy specimens from the targeted esophageal tissue site; 2. Stable disease: tumor remission is not attained, but disease progression is halted.
TERMINATED
NA
1 participants
5 years
2022-03-07
Participant Flow
Participant milestones
| Measure |
Treatment
Treated with liquid nitrogen spray cryotherapy
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
subject did not complete study
Baseline characteristics by cohort
| Measure |
Cryotherapy
n=1 Participants
Liquid nitrogen spray cryotherapy with the truFreeze device
Liquid nitrogen spray cryotherapy with the truFreeze device: Low-pressure liquid nitrogen is sprayed through an upper endoscope on the diseased esophageal tissue to freeze and destroy it. The upper endoscope enables direct visualization of mucosal freeze during spray of the liquid nitrogen onto the mucosa and avoids the need for direct contact with the tissues. The target area is frozen and thawed for several consecutive cycles. The treated tissue becomes necrotic and sloughs, with new, healthy tissue regenerating in its place.
|
|---|---|
|
Age, Categorical
>=65 years
|
0 Participants
subject did not complete study
|
|
Sex: Female, Male
Female
|
0 Participants
n=1 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=1 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: subject withdrawn before outcome measures could be assessed
The primary endpoint is to determine the response rate to spray cryotherapy. It is hypothesized that one of the two following outcomes will occur: 1. Complete response to therapy: complete tumor eradication confirmed through histologic examination of biopsy specimens from the targeted esophageal tissue site; 2. Stable disease: tumor remission is not attained, but disease progression is halted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: subject withdrawn before outcome measures could be assessed
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: subject withdrawn before outcome measures could be assessed
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: subject withdrawn before outcome measures could be assessed
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 36 monthsPopulation: subject withdrawn before outcome measures could be assessed
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: subject withdrawn before outcome measures could be assessed
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 36 monthsPopulation: subject withdrawn from study before outcomes measures could be assessed
Number of participants with adverse events; Number of adverse events within the study
Outcome measures
Outcome data not reported
Adverse Events
Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Bruce Greenwald
University of Maryland School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place