Trial Outcomes & Findings for Pilot Study of VTI Doppler Probe Use to Identify Neurovascular Bundle During Prostate Surgery (NCT NCT01794936)
NCT ID: NCT01794936
Last Updated: 2024-05-29
Results Overview
Patients are to be evaluated for erectile function at 8 month post-operative visit using validated SHIM questionnaire.
TERMINATED
NA
9 participants
8 months post-operative follow-up
2024-05-29
Participant Flow
The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in February 2012.
Participant milestones
| Measure |
VTI Probe or Non-Probe
Data per arm is not available. Columbia will never have access to this data.
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Study of VTI Doppler Probe Use to Identify Neurovascular Bundle During Prostate Surgery
Baseline characteristics by cohort
| Measure |
VTI Probe or Non-Probe
n=9 Participants
Data per arm is not available. Columbia will never have access to this data.
|
|---|---|
|
Age, Customized
18 years and older
|
9 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 months post-operative follow-upPopulation: The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in February 2012.
Patients are to be evaluated for erectile function at 8 month post-operative visit using validated SHIM questionnaire.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: During surgical procedure itself (~2-3 hours)Population: The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in February 2012.
Investigators will evaluate whether any intra-operative complications resulted from the use of the VTI probe to assess safety. Specifically, this time frame is limited from the induction of anesthesia through the completion of the surgical procedure (typically \~2-3 hours)
Outcome measures
Outcome data not reported
Adverse Events
VTI Probe or Non-Probe
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