Trial Outcomes & Findings for Evaluation of the Surfacer System Approach to Central Venous Access (NCT NCT03209050)
NCT ID: NCT03209050
Last Updated: 2023-05-30
Results Overview
Safety reported as 86.7% (26/30) % of subjects with no procedural complications at discharge through 7 days follow up.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
7 days
Results posted on
2023-05-30
Participant Flow
Participant milestones
| Measure |
Central Venous Access Placement
Central venous access placement
Central Venous Access Placement: Device inserted into the femoral vein to insert a central venous access catheter
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of the Surfacer System Approach to Central Venous Access
Baseline characteristics by cohort
| Measure |
Central Venous Access Placement
n=30 Participants
Central venous access placement
Central Venous Access Placement: Device inserted into the femoral vein to insert a central venous access catheter
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
|
30 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=99 Participants
|
|
chronic Kidney disease
|
25 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 7 daysSafety reported as 86.7% (26/30) % of subjects with no procedural complications at discharge through 7 days follow up.
Outcome measures
| Measure |
Central Venous Access Placement
n=30 Participants
Central venous access placement in 26/30 patients
Central Venous Access Placement: Device inserted into the femoral vein to insert a central venous access catheter in 26/30 patients
|
|---|---|
|
Number of Participants With Safe Insertion and Patency of Central Venous Access Catheter
|
30 participants
|
SECONDARY outcome
Timeframe: 7 daysPopulation: patients treated with central venous access device
Safety and Efficacy 90.0% (27/30) successful central venous catheter placements as assessed by patent open central venous access catheter. Ability to use the central venous access catheter for dialysis and infusion through 7 days
Outcome measures
| Measure |
Central Venous Access Placement
n=30 Participants
Central venous access placement in 26/30 patients
Central Venous Access Placement: Device inserted into the femoral vein to insert a central venous access catheter in 26/30 patients
|
|---|---|
|
Number of Participants Who Experienced Safe Use of the System to Insert Femoral Vein to Sub-clavicular Exit as Assessed by Central Venous Access Placement in 30 Patients Attempted
|
30 Participants
|
Adverse Events
Central Venous Access Placement
Serious events: 4 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Central Venous Access Placement
n=30 participants at risk
Central venous access placement
Central Venous Access Placement: Device inserted into the femoral vein to insert a central venous access catheter
|
|---|---|
|
Renal and urinary disorders
Hypotension
|
3.3%
1/30 • Number of events 1 • 4 weeks or 30 days
Overall number of participants who experienced adverse events as a result of the access procedure per definitions within 24 hours of occurrence.
|
|
Vascular disorders
Bleeding
|
6.7%
2/30 • Number of events 2 • 4 weeks or 30 days
Overall number of participants who experienced adverse events as a result of the access procedure per definitions within 24 hours of occurrence.
|
|
Vascular disorders
Hemodynamic Instability
|
3.3%
1/30 • Number of events 1 • 4 weeks or 30 days
Overall number of participants who experienced adverse events as a result of the access procedure per definitions within 24 hours of occurrence.
|
|
Vascular disorders
unintended embolization
|
3.3%
1/30 • Number of events 1 • 4 weeks or 30 days
Overall number of participants who experienced adverse events as a result of the access procedure per definitions within 24 hours of occurrence.
|
|
Vascular disorders
bleeding
|
6.7%
2/30 • Number of events 2 • 4 weeks or 30 days
Overall number of participants who experienced adverse events as a result of the access procedure per definitions within 24 hours of occurrence.
|
Other adverse events
| Measure |
Central Venous Access Placement
n=30 participants at risk
Central venous access placement
Central Venous Access Placement: Device inserted into the femoral vein to insert a central venous access catheter
|
|---|---|
|
Infections and infestations
allergic reaction
|
3.3%
1/30 • Number of events 1 • 4 weeks or 30 days
Overall number of participants who experienced adverse events as a result of the access procedure per definitions within 24 hours of occurrence.
|
Additional Information
Clinical Research Organization and Trial Manager
mmc medical international services
Phone: 9492805700
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60