Trial Outcomes & Findings for Feasibility Study: Heavy Water Tissue Labeling Protocol (NCT NCT01708525)
NCT ID: NCT01708525
Last Updated: 2017-12-11
Results Overview
Resected tissue will be analyzed to determine the rate of collagen synthesis in tissue treated with Ultherapy® compared to non-treated tissue.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
2 participants
Primary outcome timeframe
4 weeks post-treatment
Results posted on
2017-12-11
Participant Flow
Participant milestones
| Measure |
Ultherapy®-Treated Tissue
Heavy water labeled tissue receiving an Ultherapy® Treatment
Ulthera System® Treatment: Focused ultrasound energy delivered below the surface of the skin
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Feasibility Study: Heavy Water Tissue Labeling Protocol
Baseline characteristics by cohort
| Measure |
Ultherapy®-Treated Tissue
n=2 Participants
Heavy water labeled tissue receiving an Ultherapy® Treatment
Ulthera System® Treatment: Focused ultrasound energy delivered below the surface of the skin
|
|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeks post-treatmentResected tissue will be analyzed to determine the rate of collagen synthesis in tissue treated with Ultherapy® compared to non-treated tissue.
Outcome measures
| Measure |
Untreated Tissue
n=2 Participants
Heavy water labeled tissue NOT receiving an Ultherapy® Treatment
|
Ultherapy®-Treated Tissue
n=2 Participants
Heavy water labeled tissue receiving an Ultherapy® Treatment
Ulthera® System Treatment: Focused ultrasound energy delivered below the surface of the skin
|
|---|---|---|
|
Rate of Collagen Synthesis
Subject 1, Type I Collagen
|
15.71 percentage of new collagen synthesized
|
21.22 percentage of new collagen synthesized
|
|
Rate of Collagen Synthesis
Subject 1, Type III Collagen
|
36.11 percentage of new collagen synthesized
|
51.80 percentage of new collagen synthesized
|
|
Rate of Collagen Synthesis
Subject 2, Type I Collagen
|
18.53 percentage of new collagen synthesized
|
29.69 percentage of new collagen synthesized
|
|
Rate of Collagen Synthesis
Subject 2, Type III Collagen
|
50.34 percentage of new collagen synthesized
|
68.13 percentage of new collagen synthesized
|
Adverse Events
Ultherapy®-Treated Tissue
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