Trial Outcomes & Findings for Application of the Apsara Thermal Wand System (NCT NCT00662389)
NCT ID: NCT00662389
Last Updated: 2009-08-28
Results Overview
Number of Serious Adverse Events
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
4 participants
Primary outcome timeframe
Immediate
Results posted on
2009-08-28
Participant Flow
Participant milestones
| Measure |
A--Thermal Wand Application
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Application of the Apsara Thermal Wand System
Baseline characteristics by cohort
| Measure |
A--Thermal Wand Application
n=4 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age Continuous
|
61.7 years
STANDARD_DEVIATION 3.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: ImmediateNumber of Serious Adverse Events
Outcome measures
| Measure |
A--Thermal Wand Application
n=4 Participants
|
|---|---|
|
Serious Adverse Events
|
0 Number of Serious Adverse Events
|
Adverse Events
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Eve Conner, Ph.D. Consultant
Apsara Medical Corporation
Phone: 510 566-2495
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60