Trial Outcomes & Findings for The PROOF Study: The PICC Related Obstruction Of Flow Study (NCT NCT01921114)
NCT ID: NCT01921114
Last Updated: 2019-05-17
Results Overview
TERMINATED
NA
57 participants
10 (+/-3) days and any time there is clinically suspected venous thrombosis (as per standard of care)
2019-05-17
Participant Flow
The study was prematurely terminated and the PI was blinded to study data, and therefore never had access to the data and does not have any information that might help us locate it. Additionally, AngioDynamics' IT team ran a thorough search for any data related to this study and no results were found.
Participant milestones
| Measure |
BioFlo™ PICC
BioFlo™ Peripherally Inserted Central Catheter (PICC)
BioFlo™ Peripherally Inserted Central Catheter (PICC)
|
Bard® PowerPICC SOLO2®
Bard® Dual-Lumen PowerPICC SOLO2®
Bard® Dual-Lumen PowerPICC SOLO2®
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The PROOF Study: The PICC Related Obstruction Of Flow Study
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 10 (+/-3) days and any time there is clinically suspected venous thrombosis (as per standard of care)Population: The study was prematurely terminated and the PI was blinded to study data, and therefore never had access to the data and does not have any information that might help us locate it. Additionally, AngioDynamics' IT team ran a thorough search for any data related to this study and no results were found.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 30 days post-insertionPopulation: The study was prematurely terminated and the PI was blinded to study data, and therefore never had access to the data and does not have any information that might help us locate it. Additionally, AngioDynamics' IT team ran a thorough search for any data related to this study and no results were found.
Secondary objectives of this study are to investigate: * Incidence of other catheter-related complications, inclusive of catheter occlusion, catheter-related infection, technical failures, and premature catheter removals * Incidence of catheter occlusion (independently from other catheter-related complications)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 30 days post-insertionEconomic outcomes with respect to medical resource utilization requirements will be compared between the two PICC groups. Only data from US sites will be used for this analysis.
Outcome measures
Outcome data not reported
Adverse Events
BioFlo™ PICC
Bard® PowerPICC SOLO2®
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
Restriction type: LTE60