Trial Outcomes & Findings for Pivotal Study of the truSculpt Radiofrequency Device for Circumferential Reduction (NCT NCT02873104)

Results Overview

Change in Abdominal Circumferential Measurement Related to Sham and Therapeutic Group at 12 Weeks Post-treatment minus Baseline Measurement

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

70 participants

Primary outcome timeframe

12 weeks

Results posted on

2018-02-28

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment truSculpt rf device, therapeutic settings truSculpt rf device: radiofrequency device	Sham truSculpt rf device, non-therapeutic settings truSculpt rf device: radiofrequency device
Overall Study STARTED	47	23
Overall Study COMPLETED	46	23
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pivotal Study of the truSculpt Radiofrequency Device for Circumferential Reduction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=47 Participants truSculpt rf device, therapeutic settings truSculpt rf device: radiofrequency device	Sham n=23 Participants truSculpt rf device, non-therapeutic settings truSculpt rf device: radiofrequency device	Total n=70 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	47 Participants n=5 Participants	23 Participants n=7 Participants	70 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	8 Participants n=7 Participants	45 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	15 Participants n=7 Participants	25 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Change in Abdominal Circumferential Measurement Related to Sham and Therapeutic Group at 12 Weeks Post-treatment minus Baseline Measurement

Outcome measures

Outcome measures
Measure	Treatment n=46 Participants truSculpt rf device, therapeutic settings truSculpt rf device: radiofrequency device	Sham n=23 Participants truSculpt rf device, non-therapeutic settings truSculpt rf device: radiofrequency device
Difference in Circumferential Measurement Related to Sham and Therapeutic Group at 12 Weeks Post-treatment	1.9 cm Standard Error 0.1	0 cm Standard Error 0.1

SECONDARY outcome

Timeframe: 12 weeks

Comparison of the average subject improvement score for the sham group and the therapeutic group at 12 weeks post-treatment using a 0 - 4 improvement scale where 0 equals "no change" and 4 equals "Very Significant Improvement".

Outcome measures

Outcome measures
Measure	Treatment n=46 Participants truSculpt rf device, therapeutic settings truSculpt rf device: radiofrequency device	Sham n=23 Participants truSculpt rf device, non-therapeutic settings truSculpt rf device: radiofrequency device
Subject Assessment of Improvement for Both Sham Group and Therapeutic Group at 12 Weeks Post-treatment.	2.4 units on a scale Standard Deviation 1	1 units on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: 12 weeks

Comparison of the average subject satisfaction level for the sham group and therapeutic group at 12 weeks post-treatment, using a 1 - 5 scale where 1 equals "very dissatisfied" and 5 equals "very satisfied".

Outcome measures

Outcome measures
Measure	Treatment n=46 Participants truSculpt rf device, therapeutic settings truSculpt rf device: radiofrequency device	Sham n=23 Participants truSculpt rf device, non-therapeutic settings truSculpt rf device: radiofrequency device
Subject Satisfaction Level for Both Sham Group and Therapeutic Group at 12 Weeks Post-treatment.	4.1 units on a scale Standard Deviation 0.8	3.3 units on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: 12 weeks

Comparison of the average pain levels during treatment for the sham group and therapeutic group at 12 weeks post-treatment, using a 0 - 10 scale where 0 equals "No pain" and 10 equals "Worst possible pain".

Outcome measures

Outcome measures
Measure	Treatment n=47 Participants truSculpt rf device, therapeutic settings truSculpt rf device: radiofrequency device	Sham n=23 Participants truSculpt rf device, non-therapeutic settings truSculpt rf device: radiofrequency device
Subject Discomfort and Pain Levels During Treatment	5.75 units on a scale Standard Deviation 0.9	1.1 units on a scale Standard Deviation 0.3

Adverse Events

Treatment

Serious events: 0 serious events

Other events: 47 other events

Deaths: 0 deaths

Sham

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment n=47 participants at risk truSculpt rf device, therapeutic settings truSculpt rf device: radiofrequency device	Sham n=23 participants at risk truSculpt rf device, non-therapeutic settings truSculpt rf device: radiofrequency device
Skin and subcutaneous tissue disorders Erythema	100.0% 47/47 • Number of events 47	100.0% 23/23 • Number of events 23
Skin and subcutaneous tissue disorders Edema	100.0% 47/47 • Number of events 47	0.00% 0/23

Additional Information

Lourdes Moldre, NP

Cutera

Phone: 415-971-5118

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place