An interventional study of CoolSculpting® System in Non-invasive Fat Reduction, sponsored by Allergan. Completed at 7 sites in 4 countries. Open to participants aged 22 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-27.
Sponsored by Allergan · Not applicable, Interventional, and Treatment
This study aims to generate data that conveys participant's experiences such as their overall satisfaction with the CoolSculpting® treatment for their belly and love handles. By doing this, the study will provide insights for doctors to better inform participants about the expected outcomes.
Allergan is the lead sponsor of 499 studies on the registry; none are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 89 (98%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants received up to two CoolSculpting® treatment sessions for the abdomen, flanks or both 8 weeks apart. A treatment session was comprised of timed segments of cooling (treatment cycles) followed by 2 minutes of manual massage. Up to 12 cycles per treatment session were performed at the investigator's discretion.
Device: CoolSculpting® System
A treatment session is comprised of timed segments of cooling (treatment cycles) followed by 2 minutes of manual massage.
Percentage of Participants Who Reported "Satisfied" or "Very Satisfied" on Cryolipolysis Satisfaction Questionnaire (CSQ) Item #1 Overall
The CSQ is a 4-item Patient-reported Outcome (PRO) instrument that measures the participant's satisfaction with CoolSculpting® treatment of the flank, abdomen or both. Participants rated their satisfaction by answering CSQ Item 1="Rate your overall satisfaction with the fat reduction procedure on the treated area" using the following scale: Very satisfied, Satisfied, Neither satisfied nor dissatisfied, Dissatisfied or Very dissatisfied.
Time frame: 12 weeks after the final treatment session (measured at Week 12 for participants who received 1 treatment session or Week 20 for 2 treatment sessions)
Percentage of Participants Who Reported "Satisfied" or "Very Satisfied" on CSQ Item #1 in Treated Area(s)
The CSQ is a 4-item Patient-reported Outcome (PRO) instrument that measures the participant's satisfaction with CoolSculpting® treatment of the flank, abdomen or both. Participants rated their satisfaction by answering CSQ Item 1="Rate your overall satisfaction with the fat reduction procedure on the treated area" using the following scale: Very satisfied, Satisfied, Neither satisfied nor dissatisfied, Dissatisfied or Very dissatisfied.
Time frame: 12 weeks after the final treatment session (measured at Week 12 for participants who received 1 treatment session or Week 20 for 2 treatment sessions)
Percentage of Participants Who Received 1 or 2 Treatments Who Reported "Satisfied" or "Very Satisfied" on CSQ Item #1 by Number of Treatment Cycles
The CSQ is a 4-item Patient-reported Outcome (PRO) instrument that measures the participant's satisfaction with CoolSculpting® treatment of the flank, abdomen or both. Participants rated their satisfaction by answering CSQ Item 1="Rate your overall satisfaction with the fat reduction procedure on the treated area" using the following scale: Very satisfied, Satisfied, Neither satisfied nor dissatisfied, Dissatisfied or Very dissatisfied.
Time frame: 12 weeks after the final treatment session (measured at Week 12 for participants who received 1 treatment session or Week 20 for 2 treatment sessions)
Percentage of Participants by Body Mass Index (BMI) Categories Who Reported "Satisfied" or "Very Satisfied" on CSQ Item #1
The CSQ is a 4-item Patient-reported Outcome (PRO) instrument that measures the participant's satisfaction with CoolSculpting® treatment of the flank, abdomen or both. Participants rated their satisfaction by answering CSQ Item 1="Rate your overall satisfaction with the fat reduction procedure on the treated area" using the following scale: Very satisfied, Satisfied, Neither satisfied nor dissatisfied, Dissatisfied or Very dissatisfied. Participants were analyzed based on BMI ranges from 18.5 to \< 25.0 and 25.0 to \< 30.0. BMI was defined as weight in kilograms divided by height in meters squared (kg/m\^2).
Time frame: 12 weeks after the final treatment session (measured at Week 12 for participants who received 1 treatment session or Week 20 for 2 treatment sessions)
Change From Baseline in Volume of Fat as Measured by 3 Dimensional (3D) Photography
Change in the volume of fat was assessed by a 3D stereoscopic camera which was used to generate a 3D image of the body, allowing quantification of the abdomen and flank areas. A 2-step 3D matching algorithm process was used, to identify the change of volume in milliliters (mL).
Time frame: Baseline to 8 Weeks post-Treatment 1 and 12 Weeks post-Final Treatment 2
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, users, or other persons, if related to the investigational medical device. A SAE is any AE, that is fatal, life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. A TEAE is defined as any new adverse event or worsening of an existing condition after initiation of treatment.
Time frame: First treatment to Follow-up/Exit Visit (Week 12 +/- 14 days for those participants who received 1 treatment and Week 20 +/- 14 days for those participants who received 2 treatments)
Percentage of Participants With Adverse Device Effects (ADEs) and Serious Adverse Device Effects (SADEs)
An ADE was defined in accordance with ISO 14155 as an AE related to the use of an investigational medical device or defined as AE with a reasonable possibility (Possible, Probable, or Causal relationship) that the device caused the event. SADE is an ADE that might have led to any SAE consequences if a suitable action had not been taken or intervention had not been made.
Time frame: First treatment to Follow-up/Exit Visit (Week 12 +/- 14 days for those participants who received 1 treatment and Week 20 +/- 14 days for those participants who received 2 treatments)
| Milestone | CoolSculpting® System |
|---|---|
| Started | 120 |
| Safety population | 112 |
| Received treatment in session 2 | 107 |
| Evaluable population | 106 |
| Completed | 105 |
| Not completed | 15 |
| Withdrew: Protocol deviation | 2 |
| Withdrew: Technical problems | 4 |
| Withdrew: Withdrawal by subject | 4 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Reason not specified | 4 |
The CSQ is a 4-item Patient-reported Outcome (PRO) instrument that measures the participant's satisfaction with CoolSculpting® treatment of the flank, abdomen or both. Participants rated their satisfaction by answering CSQ Item 1="Rate your overall satisfaction with the fat reduction procedure on the treated area" using the following scale: Very satisfied, Satisfied, Neither satisfied nor dissatisfied, Dissatisfied or Very dissatisfied.
| percentage of participants | CoolSculpting® System |
|---|---|
| Percentage of Participants Who Reported "Satisfied" or "Very Satisfied" on Cryolipolysis Satisfaction Questionnaire (CSQ) Item #1 Overall | 89.6 (83.8 to 95.4) |
The CSQ is a 4-item Patient-reported Outcome (PRO) instrument that measures the participant's satisfaction with CoolSculpting® treatment of the flank, abdomen or both. Participants rated their satisfaction by answering CSQ Item 1="Rate your overall satisfaction with the fat reduction procedure on the treated area" using the following scale: Very satisfied, Satisfied, Neither satisfied nor dissatisfied, Dissatisfied or Very dissatisfied.
| percentage of participants | CoolSculpting® System |
|---|---|
| Abdomen | 87.1 (80.6 to 93.7) |
| Flanks | 93.1 (88.1 to 98.0) |
| Abdomen and Flanks | 89.6 (83.5 to 95.7) |
The CSQ is a 4-item Patient-reported Outcome (PRO) instrument that measures the participant's satisfaction with CoolSculpting® treatment of the flank, abdomen or both. Participants rated their satisfaction by answering CSQ Item 1="Rate your overall satisfaction with the fat reduction procedure on the treated area" using the following scale: Very satisfied, Satisfied, Neither satisfied nor dissatisfied, Dissatisfied or Very dissatisfied.
| percentage of participants | CoolSculpting® System |
|---|---|
| 24 Treatment Cycles | 92.2 (84.8 to 99.5) |
| 22 Treatment Cycles | 100.0 (100.0 to 100.0) |
| 21 Treatment Cycles | 100.0 (100.0 to 100.0) |
| 20 Treatment Cycles | 100.0 (100.0 to 100.0) |
| 18 Treatment Cycles | 80.0 (44.9 to 100.0) |
| 17 Treatment Cycles | 100.0 (100.0 to 100.0) |
| 16 Treatment Cycles | 92.3 (77.8 to 100.0) |
| 15 Treatment Cycles | 100.0 (100.0 to 100.0) |
| 14 Treatment Cycles | 66.7 (28.9 to 100.0) |
| 13 Treatment Cycles | 100.0 (100.0 to 100.0) |
| 12 Treatment Cycles | 80.0 (55.2 to 100.0) |
| 11 Treatment Cycles | 100.0 (100.0 to 100.0) |
| 10 Treatment Cycles | 100.0 (100.0 to 100.0) |
| 9 Treatment Cycles | 100.0 (100.0 to 100.0) |
| 7 Treatment Cycles | 0 (0 to 0) |
| 6 Treatment Cycles | 100.0 (100.0 to 100.0) |
| 5 Treatment Cycles | 100.0 (100.0 to 100.0) |
| 2 Treatment Cycles | 100.0 (100.0 to 100.0) |
The CSQ is a 4-item Patient-reported Outcome (PRO) instrument that measures the participant's satisfaction with CoolSculpting® treatment of the flank, abdomen or both. Participants rated their satisfaction by answering CSQ Item 1="Rate your overall satisfaction with the fat reduction procedure on the treated area" using the following scale: Very satisfied, Satisfied, Neither satisfied nor dissatisfied, Dissatisfied or Very dissatisfied. Participants were analyzed based on BMI ranges from 18.5 to \< 25.0 and 25.0 to \< 30.0. BMI was defined as weight in kilograms divided by height in meters squared (kg/m\^2).
| percentage of participants | CoolSculpting® System |
|---|---|
| BMI 18.5 - < 25 | 88.5 (79.8 to 97.1) |
| BMI 25 - ≤ 30 | 90.7 (83.0 to 98.5) |
Change in the volume of fat was assessed by a 3D stereoscopic camera which was used to generate a 3D image of the body, allowing quantification of the abdomen and flank areas. A 2-step 3D matching algorithm process was used, to identify the change of volume in milliliters (mL).
| mL | CoolSculpting® System |
|---|---|
| Change from Baseline at 8 Weeks Post-Treatment Session 1 | -149.1 ± 280.61 |
| Change from Baseline at 12 Weeks Post-Final Treatment | -264.8 ± 411.36 |
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, users, or other persons, if related to the investigational medical device. A SAE is any AE, that is fatal, life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. A TEAE is defined as any new adverse event or worsening of an existing condition after initiation of treatment.
| percentage of participants | CoolSculpting®: Treatment Session 1 | CoolSculpting®: Treatment Session 2 |
|---|---|---|
| TEAE | 14.3 | 10.3 |
| SAE | 0.0 | 0.9 |
An ADE was defined in accordance with ISO 14155 as an AE related to the use of an investigational medical device or defined as AE with a reasonable possibility (Possible, Probable, or Causal relationship) that the device caused the event. SADE is an ADE that might have led to any SAE consequences if a suitable action had not been taken or intervention had not been made.
| percentage of participants | CoolSculpting®: Treatment Session 1 | CoolSculpting®: Treatment Session 2 |
|---|---|---|
| ADE | 14.3 | 9.3 |
| SADE | 0 | 0 |
Collected over First treatment to Follow-up/Exit Visit (Week 12 +/- 14 days for those participants who received 1 treatment and Week 20 +/- 14 days for those participants who received 2 treatments). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CoolSculpting®: Treatment Session 1 | 0/112 (0%) | 0/112 (0%) | 10/112 (8.9%) |
| CoolSculpting®: Treatment Session 2 | 0/107 (0%) | 1/107 (0.9%) | 1/107 (0.9%) |
| Event | CoolSculpting®: Treatment Session 1 | CoolSculpting®: Treatment Session 2 |
|---|---|---|
| Abortion spontaneousPregnancy, puerperium and perinatal conditions | 0/83 | 1/79 |
| Event | CoolSculpting®: Treatment Session 1 | CoolSculpting®: Treatment Session 2 |
|---|---|---|
| PruritusSkin and subcutaneous tissue disorders | 10/112 | 1/107 |
Safety Population included all participants who had at least 1 of the treatment procedures conducted.
| Age, Continuous(years) | CoolSculpting® System |
|---|---|
| Mean | 42.5 ± 9.86 |
| Sex: Female, Male(Participants) | CoolSculpting® System |
|---|---|
| Female | 83 |
| Male | 29 |
| Race/Ethnicity, Customized(Participants) | CoolSculpting® System |
|---|---|
| White | 48 |
| Black | 1 |
| Asian - Chinese | 51 |
| Asian - Korean | 1 |
| Asian, Other | 9 |
| Arab/Middle Eastern | 1 |
| Other | 1 |
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