Trial Outcomes & Findings for Neo-nervegenesis in Inguinal Hernia Implant ProFlor (NCT NCT04171102)
NCT ID: NCT04171102
Last Updated: 2020-06-17
Results Overview
Post-operative assessment of neonervegenesis within hernia implant ProFlor at short, mid and long term post-implantation
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
3 weeks until 8 months post-implantation
Results posted on
2020-06-17
Participant Flow
Participant milestones
| Measure |
Neonervegenesis in ProFlor Hernia Implant in the Short Term
Determining presence and level of maturation of nervous structures in the hernia implant ProFlor at 3-5 weeks post-implantation
|
Neonervegenesis in ProFlor Hernia Implant in the Mid Term
Determining presence and level of maturation of nervous structures in the hernia implant ProFlor at 3-4 months post-implantation
|
Neonervegenesis in ProFlor Hernia Implant in the Long Term
Determining presence and level of maturation of nervous structures in the hernia implant ProFlor at 6-8 months post-implantation
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
5
|
6
|
|
Overall Study
COMPLETED
|
4
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Short Term Post-implantation
n=4 Participants
Determining presence and level of maturation of nervous structures in the hernia implant ProFlor at 3-5 weeks post-implantation
|
Mid Term Post-implantation
n=5 Participants
Determining presence and level of maturation of nervous structures in the hernia implant ProFlor at 3-4 months post-implantation
|
Long Term Post-implantation
n=6 Participants
Determining presence and level of maturation of nervous structures in the hernia implant ProFlor at 6-8 months post-implantation
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=15 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=4 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=6 Participants
|
11 Participants
n=15 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=4 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=6 Participants
|
4 Participants
n=15 Participants
|
|
Age, Continuous
|
53.6 years
STANDARD_DEVIATION 4561 • n=4 Participants
|
59.6 years
STANDARD_DEVIATION 4871 • n=5 Participants
|
61.5 years
STANDARD_DEVIATION 4881 • n=6 Participants
|
58.23 years
STANDARD_DEVIATION 4581 • n=15 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=4 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=6 Participants
|
15 Participants
n=15 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Italy
|
4 Participants
n=4 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=6 Participants
|
15 Participants
n=15 Participants
|
PRIMARY outcome
Timeframe: 3 weeks until 8 months post-implantationPopulation: Patients who underwent inguinal hernia repair with ProFlor
Post-operative assessment of neonervegenesis within hernia implant ProFlor at short, mid and long term post-implantation
Outcome measures
| Measure |
Short Term Post Implantation
n=4 Participants
Determining presence and level of maturation of nervous structures in the hernia implant ProFlor at 3-5 weeks post implantation
|
Mid Term Post Implantation
n=5 Participants
Determining presence and level of maturation of nervous structures in the hernia implant ProFlor at 3-4 months post implantation
|
Long Term Post-implantation
n=6 Participants
Determining presence and level of maturation of nervous structures in the hernia implant ProFlor at 6-8 months post implantation
|
|---|---|---|---|
|
Ingrowth of Newly Formed Nervous Elements Within Hernia Implant ProFlor
|
999.75 μm^2
Standard Deviation 113.32
|
1044 μm^2
Standard Deviation 695.95
|
2094 μm^2
Standard Deviation 490.82
|
Adverse Events
Short Term Post-implantation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mid Term Post-implantation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Long Term Post-implantation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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