Trial Outcomes & Findings for Radio Frequency (RF) Device for Reduction in Size of Localized Areas of the Body (NCT NCT00953160)

NCT ID: NCT00953160

Last Updated: 2023-09-18

Results Overview

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 76 participants
• Primary outcome timeframe: Baseline and 6 months post final treatment
• Results posted on: 2023-09-18

Participant Flow

The study subjects were recruited in the medical clinic 01/01/09 through 01/13/10.

Participant milestones

Measure	Radiofrequency (RF) Treatment Abdomen, flank or thigh treated with RF device (average of 2 treatments and average dosage of 30kJ)
Overall Study STARTED	76
Overall Study COMPLETED	49
Overall Study NOT COMPLETED	27

Reasons for withdrawal

Measure	Radiofrequency (RF) Treatment Abdomen, flank or thigh treated with RF device (average of 2 treatments and average dosage of 30kJ)
Overall Study Lost to Follow-up	23
Overall Study Withdrawal by Subject	4

Baseline Characteristics

Radio Frequency (RF) Device for Reduction in Size of Localized Areas of the Body

Baseline characteristics by cohort

Measure	Radiofrequency (RF) Treatment n=76 Participants Abdomen, flank or thigh treated with RF device (average of 2 treatments and average dosage of 30kJ)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	76 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	43 years STANDARD_DEVIATION 8.5 • n=5 Participants
Sex: Female, Male Female	69 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment United States	76 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months post final treatment

Outcome measures

Measure	Radiofrequency (RF) Treatment n=49 Participants Abdomen, flank or thigh treated with RF device (average of 2 treatments and average dosage of 30kJ)
Change in Circumference (cm) Abdomen	-0.5 Centimeters (cm) Standard Deviation 2.2
Change in Circumference (cm) Thigh	0.6 Centimeters (cm) Standard Deviation 4.7
Change in Circumference (cm) Flank	-1.4 Centimeters (cm) Standard Deviation 2.1

SECONDARY outcome

Timeframe: Baseline and 6 months post final treatment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 months after the last treatment

At each visit (treatment and follow-up) or until resolution of AEs

Outcome measures

Measure	Radiofrequency (RF) Treatment n=49 Participants Abdomen, flank or thigh treated with RF device (average of 2 treatments and average dosage of 30kJ)
The Number of Participants With Adverse Events Edema	1 Participants
The Number of Participants With Adverse Events Lumps	3 Participants

Adverse Events

Radiofrequency (RF) Treatment

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Radiofrequency (RF) Treatment n=49 participants at risk Abdomen, flank or thigh treated with RF device (average of 2 treatments and average dosage of 30kJ)
Injury, poisoning and procedural complications Lumps	6.1% 3/49 • Number of events 49 • 6 months Subjects were assessed and followed up for adverse events at 6 weeks, 3 months and 6 months after the RF treatment.

Additional Information

Ayse Turley, Clinical Development Researcher

Cutera Inc.

Phone: 415-657-5665

Email: aturley@cutera.com

Results disclosure agreements

• Principal investigator is a sponsor employee "The Doctor will not publish or present the results of the Study, or speak publicly about it, unless Cutera has first had a reasonable opportunity to review and comment on the contents of the proposed presentation or publication."
• Publication restrictions are in place

Restriction type: OTHER