Trial Outcomes & Findings for Study To Assess Radiofrequency Diathermocontraction Device For Muscle Stimulation And The Treatment Of Abdominal Fat (NCT NCT05388617)
NCT ID: NCT05388617
Last Updated: 2023-11-29
Results Overview
The number of subjects satisfied with their treatment will be reported.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
30 days follow up.
Results posted on
2023-11-29
Participant Flow
Participant milestones
| Measure |
Group A
Subjects in Group A will receive up to 8 treatments with the Brera/Med 400 device on their abdomen or flanks. Subjects may receive a phone call 1 week (1-7 days) after each treatment to record side effects. Subjects will return for follow up visits at 30 and 90 days post last treatment for efficacy and side effects assessments.
Brera: The applicators will be placed in contact with the skin. The entire defined treatment area will then be treated by delivering energy to the skin. Temperature may be continuously monitored and recorded during treatment. Parameters may be adjusted throughout the treatment to increase subject comfort.
|
Group B
Subjects in Group B may receive up to 8 treatments with the Brera/Med 400 device on their abdomen and/or flanks. Subjects may receive a phone call 1 week (1-7 days) after each treatment to record side effects. Subjects may be asked return for follow up visits at 30 and 90 days post last treatment for efficacy and side effects assessments. Outcome measures will not be taken for subjects enrolled in this group.
Brera: The applicators will be placed in contact with the skin. The entire defined treatment area will then be treated by delivering energy to the skin. Temperature may be continuously monitored and recorded during treatment. Parameters may be adjusted throughout the treatment to increase subject comfort.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
0
|
|
Overall Study
COMPLETED
|
16
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study To Assess Radiofrequency Diathermocontraction Device For Muscle Stimulation And The Treatment Of Abdominal Fat
Baseline characteristics by cohort
| Measure |
Group A
n=16 Participants
Subjects in Group A will receive up to 8 treatments with the Brera/Med 400 device on their abdomen or flanks. Subjects may receive a phone call 1 week (1-7 days) after each treatment to record side effects. Subjects will return for follow up visits at 30 and 90 days post last treatment for efficacy and side effects assessments.
Brera: The applicators will be placed in contact with the skin. The entire defined treatment area will then be treated by delivering energy to the skin. Temperature may be continuously monitored and recorded during treatment. Parameters may be adjusted throughout the treatment to increase subject comfort.
|
Group B
Subjects in Group B may receive up to 8 treatments with the Brera/Med 400 device on their abdomen and/or flanks. Subjects may receive a phone call 1 week (1-7 days) after each treatment to record side effects. Subjects may be asked return for follow up visits at 30 and 90 days post last treatment for efficacy and side effects assessments. Outcome measures will not be taken for subjects enrolled in this group.
Brera: The applicators will be placed in contact with the skin. The entire defined treatment area will then be treated by delivering energy to the skin. Temperature may be continuously monitored and recorded during treatment. Parameters may be adjusted throughout the treatment to increase subject comfort.
|
Total
n=16 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
|
16 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
16 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
|
14 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
13 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian/Indian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Dominican/American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type I
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type II
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type III
|
10 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type IV
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type V
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type VI
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 days follow up.Population: There were no subjects enrolled for Group B.
The number of subjects satisfied with their treatment will be reported.
Outcome measures
| Measure |
Group A
n=16 Participants
Subjects in Group A will receive up to 8 treatments with the Brera/Med 400 device on their abdomen or flanks. Subjects may receive a phone call 1 week (1-7 days) after each treatment to record side effects. Subjects will return for follow up visits at 30 and 90 days post last treatment for efficacy and side effects assessments.
Brera: The applicators will be placed in contact with the skin. The entire defined treatment area will then be treated by delivering energy to the skin. Temperature may be continuously monitored and recorded during treatment. Parameters may be adjusted throughout the treatment to increase subject comfort.
|
Group B
Subjects in Group B may receive up to 8 treatments with the Brera/Med 400 device on their abdomen and/or flanks. Subjects may receive a phone call 1 week (1-7 days) after each treatment to record side effects. Subjects may be asked return for follow up visits at 30 and 90 days post last treatment for efficacy and side effects assessments. Outcome measures will not be taken for subjects enrolled in this group.
Brera: The applicators will be placed in contact with the skin. The entire defined treatment area will then be treated by delivering energy to the skin. Temperature may be continuously monitored and recorded during treatment. Parameters may be adjusted throughout the treatment to increase subject comfort.
|
|---|---|---|
|
Number of Subjects Satisfied
|
10 number of participants satisfied
|
—
|
Adverse Events
Group A
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Group B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A
n=16 participants at risk
Subjects in Group A will receive up to 8 treatments with the Brera/Med 400 device on their abdomen or flanks. Subjects may receive a phone call 1 week (1-7 days) after each treatment to record side effects. Subjects will return for follow up visits at 30 and 90 days post last treatment for efficacy and side effects assessments.
Brera: The applicators will be placed in contact with the skin. The entire defined treatment area will then be treated by delivering energy to the skin. Temperature may be continuously monitored and recorded during treatment. Parameters may be adjusted throughout the treatment to increase subject comfort.
|
Group B
Subjects in Group B may receive up to 8 treatments with the Brera/Med 400 device on their abdomen and/or flanks. Subjects may receive a phone call 1 week (1-7 days) after each treatment to record side effects. Subjects may be asked return for follow up visits at 30 and 90 days post last treatment for efficacy and side effects assessments. Outcome measures will not be taken for subjects enrolled in this group.
Brera: The applicators will be placed in contact with the skin. The entire defined treatment area will then be treated by delivering energy to the skin. Temperature may be continuously monitored and recorded during treatment. Parameters may be adjusted throughout the treatment to increase subject comfort.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Erythema
|
18.8%
3/16 • Adverse events were captured throughout subject participation in the study, approximately 30 days.
13 out of the 16 subjects who received treatments in Group A observed adverse events.
|
—
0/0 • Adverse events were captured throughout subject participation in the study, approximately 30 days.
13 out of the 16 subjects who received treatments in Group A observed adverse events.
|
|
Skin and subcutaneous tissue disorders
Cramping
|
37.5%
6/16 • Adverse events were captured throughout subject participation in the study, approximately 30 days.
13 out of the 16 subjects who received treatments in Group A observed adverse events.
|
—
0/0 • Adverse events were captured throughout subject participation in the study, approximately 30 days.
13 out of the 16 subjects who received treatments in Group A observed adverse events.
|
|
Skin and subcutaneous tissue disorders
Muscle Twitching
|
6.2%
1/16 • Adverse events were captured throughout subject participation in the study, approximately 30 days.
13 out of the 16 subjects who received treatments in Group A observed adverse events.
|
—
0/0 • Adverse events were captured throughout subject participation in the study, approximately 30 days.
13 out of the 16 subjects who received treatments in Group A observed adverse events.
|
|
Skin and subcutaneous tissue disorders
Pain/Tenderness
|
50.0%
8/16 • Adverse events were captured throughout subject participation in the study, approximately 30 days.
13 out of the 16 subjects who received treatments in Group A observed adverse events.
|
—
0/0 • Adverse events were captured throughout subject participation in the study, approximately 30 days.
13 out of the 16 subjects who received treatments in Group A observed adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI cannot disclose confidential or proprietary information until after it becomes generally known or available to the public.
- Publication restrictions are in place
Restriction type: OTHER