Trial Outcomes & Findings for T-DOC® 5 Fr Pediatric Clinical Investigation (NCT NCT03429270)
NCT ID: NCT03429270
Last Updated: 2020-06-09
Results Overview
A binary clinician response after each UDS study is used to assess if it is clinically adequate (success) or inadequate (failure) in each patients questionnaire and presented to the clinician where safety (Yes the device is safe and No the device is not safe) will be reported. A minimum of 10 male and 10 female subjects, with an overall minimum of 28, and maximum of 33 subjects.
COMPLETED
NA
28 participants
2 months
2020-06-09
Participant Flow
Participant milestones
| Measure |
Urodynamics Arm
Urodynamic testing and data collection(per protocol) using the TDOC 5Fr catheters.
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Urodynamics Arm
n=28 Participants
TDOC 5Fr: A Pivotal Study to Assess the Performance, Safety and Usability of a New 5 French Air-Charged Catheter for Performing Urodynamic Studies on Pediatric Subjects
|
|---|---|
|
Age, Categorical
<=18 years
|
28 Participants
n=28 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=28 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=28 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=28 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=28 Participants
|
PRIMARY outcome
Timeframe: 2 monthsA binary clinician response after each UDS study is used to assess if it is clinically adequate (success) or inadequate (failure) in each patients questionnaire and presented to the clinician where safety (Yes the device is safe and No the device is not safe) will be reported. A minimum of 10 male and 10 female subjects, with an overall minimum of 28, and maximum of 33 subjects.
Outcome measures
| Measure |
Urodynamics Arm
n=28 Participants
TDOC 5Fr: A Pivotal Study to Assess the Performance, Safety and Usability of a New 5 French Air-Charged Catheter for Performing Urodynamic Studies on Pediatric Subjects
|
|---|---|
|
The Number of Patients in Which the T-DOC® 5 Fr Catheters Are Safe in Measuring Urodynamic Pressures in Pediatric Subjects (12 Years of Age and Younger).
|
28 Participants
|
PRIMARY outcome
Timeframe: 2 monthsA binary clinician response after each UDS study is used to assess if it is clinically adequate (success) or inadequate (failure) in each patients questionnaire and presented to the clinician where effectiveness (Yes the device is effective and No the device is not effective) will be reported. A minimum of 10 male and 10 female subjects, with an overall minimum of 28, and maximum of 33 subjects.
Outcome measures
| Measure |
Urodynamics Arm
n=28 Participants
TDOC 5Fr: A Pivotal Study to Assess the Performance, Safety and Usability of a New 5 French Air-Charged Catheter for Performing Urodynamic Studies on Pediatric Subjects
|
|---|---|
|
The Number of Patients in Which the T-DOC® 5 Fr Catheters Are Effective in Measuring Urodynamic Pressures in Pediatric Subjects (12 Years of Age and Younger).
|
28 Participants
|
Adverse Events
Urodynamics Arm
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Urodynamics Arm
n=28 participants at risk
TDOC 5Fr: A Pivotal Study to Assess the Performance, Safety and Usability of a New 5 French Air-Charged Catheter for Performing Urodynamic Studies on Pediatric Subjects
|
|---|---|
|
Renal and urinary disorders
Dysuria
|
10.7%
3/28 • Number of events 3 • Through study completion, an average of 5 to 7 days
|
|
Gastrointestinal disorders
Hematochezia
|
3.6%
1/28 • Number of events 1 • Through study completion, an average of 5 to 7 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60