Trial Outcomes & Findings for Trim II for Noninvasive Lipolysis and Circumference Reduction of Abdomen. (NCT NCT05398159)

Last Updated: 2024-06-11

Results Overview

Efficacy of the Trim II treatment for lipolysis and abdominal circumference reduction. Evaluation of change in abdomen circumference using tape measurements in cm at the 3 months follow-up visit comparing to baseline. Success criteria: Statistically significant reduction in abdominal circumference tape measurements at the 3 months follow-up visit compared to baseline

Recruitment status

COMPLETED

Study phase

Target enrollment

75 participants

Primary outcome timeframe

3 months

Results posted on

2024-06-11

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment 3 bi-weekly treatments Trim II: Eligible subjects will receive 3 bi-weekly treatments (once in 2 weeks) with Trim II hands-free applicator belts according to the study protocol. Each treatment duration will be 45-60 minutes.
Overall Study STARTED	75
Overall Study COMPLETED	44
Overall Study NOT COMPLETED	31

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

dropouts

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=44 Participants 3 bi-weekly treatments Trim II: Eligible subjects will receive 3 bi-weekly treatments (once in 2 weeks) with Trim II hands-free applicator belt according to the study protocol. Each treatment duration will be 45-60 minutes.
Age, Continuous	47.6 years STANDARD_DEVIATION 12.9 • n=5 Participants • dropouts
Sex: Female, Male Female	39 Participants n=5 Participants • dropouts
Sex: Female, Male Male	5 Participants n=5 Participants • dropouts
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 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	4 Participants n=5 Participants
Race (NIH/OMB) White	38 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	44 participants n=5 Participants • dropouts
Skin type Skin type I	5 Participants n=5 Participants
Skin type Skin type II	24 Participants n=5 Participants
Skin type Skin type III	7 Participants n=5 Participants
Skin type Skin type IV	5 Participants n=5 Participants
Skin type Skin type V	3 Participants n=5 Participants
Skin type Skin type VI	0 Participants n=5 Participants
Body Mass Index	24 units of kg/m2 STANDARD_DEVIATION 3.0 • n=5 Participants
Subjects Height	66.1 inch STANDARD_DEVIATION 4 • n=5 Participants
Subjects Weight	149.8 pounds STANDARD_DEVIATION 21.5 • n=5 Participants
Circumference Measurements	91.4 cm STANDARD_DEVIATION 7.6 • n=5 Participants
Caliper Measurements	22.9 mm STANDARD_DEVIATION 10.6 • n=5 Participants
Ultrasound measurements of fat thickness	24.5 mm STANDARD_DEVIATION 5.9 • n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: treatment arm

Outcome measures

Outcome measures
Measure	Treatment n=44 Participants 3 bi-weekly treatments Trim II: Eligible subjects will receive 3 bi-weekly treatments (once in 2 weeks) with Trim II hands-free applicator belt according to the study protocol. Each treatment duration will be 45-60 minutes.
Evaluation of Change in Abdomen Circumference Using Tape Measurements in cm at the 3 Months Follow-up Visit Comparing to Baseline.	89.5 CM Standard Deviation 8.3

PRIMARY outcome

Timeframe: 3 months

Number of participants with incidence of Treatment-Emergent Adverse Events \[Safety and Tolerability\]) will be followed throughout the whole study. Observation, assessment, and recording of potential reactions by the investigator. Evaluations will be done immediately after each treatment and at the follow-up visits. The frequency, severity, and causality of reactions will be recorded.

Outcome measures

Outcome measures
Measure	Treatment n=44 Participants 3 bi-weekly treatments Trim II: Eligible subjects will receive 3 bi-weekly treatments (once in 2 weeks) with Trim II hands-free applicator belt according to the study protocol. Each treatment duration will be 45-60 minutes.
Safety of the Trim II Treatment for Lipolysis and Abdominal Circumference Reduction.	2 participants

SECONDARY outcome

Timeframe: 3 months

Success criteria: Correct identification of baseline and 3-month follow-up visit photographs of the abdomen (treatment) area in at least 70% of treated subjects by two blinded evaluators.

Outcome measures

Outcome measures
Measure	Treatment n=44 Participants 3 bi-weekly treatments Trim II: Eligible subjects will receive 3 bi-weekly treatments (once in 2 weeks) with Trim II hands-free applicator belt according to the study protocol. Each treatment duration will be 45-60 minutes.
Percentage of Participants With Baseline and 3 Month Abdomen Photographs Correctly Identified by Two Blind Evaluators	86.4 percentage of participants

SECONDARY outcome

Timeframe: 3 months

Success criteria: statistically significant change in fat thickness of the abdomen (treatment) area measurements at the 3 months follow-up visit compared to baseline.

Outcome measures

Outcome measures
Measure	Treatment n=44 Participants 3 bi-weekly treatments Trim II: Eligible subjects will receive 3 bi-weekly treatments (once in 2 weeks) with Trim II hands-free applicator belt according to the study protocol. Each treatment duration will be 45-60 minutes.
Change in Abdominal Fat Thickness Measured by Ultrasound Imaging (USI) at the 3 Months Follow-up Visit Comparing to Baseline.	21.4 mm Standard Deviation 5.3

SECONDARY outcome

Timeframe: 3 months

Subject's satisfaction with the therapy results was evaluated through the Subject Satisfaction Questionnaire (5-point scale). The higher the score the better the outcome. 2-Very satisfied, 1-satisfied, 0-indifferent, -1 disappointed, -2- very disappointed

Outcome measures

Outcome measures
Measure	Treatment n=44 Participants 3 bi-weekly treatments Trim II: Eligible subjects will receive 3 bi-weekly treatments (once in 2 weeks) with Trim II hands-free applicator belt according to the study protocol. Each treatment duration will be 45-60 minutes.
Subject's Satisfaction With Study Treatment at 3 Months Follow-up Visit.	0.63 score on a scale Interval -2.0 to 2.0

SECONDARY outcome

Timeframe: Immediately post each treatment once in 2 weeks for 6 weeks

Average of comfort post treatment evaluated using the Therapy Comfort Questionnaire. Scored from-2 to +2. The higher the score the better the outcome. Average value is calculated

Outcome measures

Outcome measures
Measure	Treatment n=44 Participants 3 bi-weekly treatments Trim II: Eligible subjects will receive 3 bi-weekly treatments (once in 2 weeks) with Trim II hands-free applicator belt according to the study protocol. Each treatment duration will be 45-60 minutes.
Treatment Comfort During the Study Treatment.	0.61 score on a scale Interval -2.0 to 2.0

Adverse Events

Treatment

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment n=75 participants at risk 3 bi-weekly treatments Trim II: Eligible subjects will receive 3 bi-weekly treatments (once in 2 weeks) with Trim II hands-free applicator belt according to the study protocol. Each treatment duration will be 45-60 minutes.
Skin and subcutaneous tissue disorders burn	1.3% 1/75 • Number of events 1 • 3 months
Skin and subcutaneous tissue disorders blisters	1.3% 1/75 • Number of events 1 • 3 months

Additional Information

Maria Shusterman

InMode

Phone: 9057076787

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place