Trial Outcomes & Findings for Post-Market Clinical Follow Up Study to Collect Additional Data and Imaging (NCT NCT04880070)
NCT ID: NCT04880070
Last Updated: 2023-06-15
Results Overview
Subjects had their gene expression relative to their own baseline samples analyzed using nSolver 4.0 software, and this was done 14 days post treatment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
5 participants
Primary outcome timeframe
14 days post treatment
Results posted on
2023-06-15
Participant Flow
Participant milestones
| Measure |
Shockwave Device
The Shockwave device will be used on multiple areas of the body for the purpose of treating connective tissue.
Shockwave Treatment: Self-controlled, single-arm group using the Shockwave device.
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Post-Market Clinical Follow Up Study to Collect Additional Data and Imaging
Baseline characteristics by cohort
| Measure |
Shockwave Device
n=5 Participants
The Shockwave device will be used on multiple areas of the body for the purpose of treating connective tissue.
Shockwave Treatment: Self-controlled, single-arm group using the Shockwave device.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
5 Participants
n=5 Participants
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type I
|
1 Participants
n=5 Participants
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type II
|
2 Participants
n=5 Participants
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type III
|
2 Participants
n=5 Participants
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type IV
|
0 Participants
n=5 Participants
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type V
|
0 Participants
n=5 Participants
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type VI
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 days post treatmentPopulation: 1 subject did not have their 14 day sample analyzed.
Subjects had their gene expression relative to their own baseline samples analyzed using nSolver 4.0 software, and this was done 14 days post treatment.
Outcome measures
| Measure |
Shockwave Device
n=4 Participants
The Shockwave device will be used on multiple areas of the body for the purpose of treating connective tissue.
Shockwave Treatment: Self-controlled, single-arm group using the Shockwave device.
|
|---|---|
|
# of Subjects With Altered Gene Expression
|
4 Participants
|
Adverse Events
Shockwave Device
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 The PI cannot disclose confidential or proprietary information until after it becomes generally known or available to the public.
- Publication restrictions are in place
Restriction type: OTHER