Trial Outcomes & Findings for International CoolSculpting: Study to Evaluate Patient Satisfaction for Non-Invasive Fat Reduction in Abdomen and/or Flanks (iCOOL) (NCT NCT03909100)

Last Updated: 2023-06-27

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

120 participants

Primary outcome timeframe

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)

Results posted on

2023-06-27

Participant Flow

Participant milestones

Participant milestones
Measure	CoolSculpting® System 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.
Overall Study STARTED	120
Overall Study Safety Population	112
Overall Study Received Treatment in Session 2	107
Overall Study Evaluable Population	106
Overall Study COMPLETED	105
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Reasons for withdrawal
Measure	CoolSculpting® System 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.
Overall Study Protocol Deviation	2
Overall Study Technical Problems	4
Overall Study Withdrawal by Subject	4
Overall Study Lost to Follow-up	1
Overall Study Reason not Specified	4

Baseline Characteristics

International CoolSculpting: Study to Evaluate Patient Satisfaction for Non-Invasive Fat Reduction in Abdomen and/or Flanks (iCOOL)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CoolSculpting® System n=112 Participants 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.
Age, Continuous	42.5 years STANDARD_DEVIATION 9.86 • n=5 Participants
Sex: Female, Male Female	83 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants
Race/Ethnicity, Customized White	48 Participants n=5 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Chinese	51 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Korean	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian, Other	9 Participants n=5 Participants
Race/Ethnicity, Customized Arab/Middle Eastern	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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)

Population: Evaluable Population included all participants who signed the ICF, had at least 1 of the procedures conducted, and also reported the CSQ Item 1 at 12 weeks after the final treatment (measured at Week 12 for participants who received 1 treatment session and at Week 20 for participants who received 2 treatment sessions).

Outcome measures

Outcome measures
Measure	CoolSculpting® System n=106 Participants 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.	CoolSculpting®: Treatment Session 2 Participants who received a second CoolSculpting® treatment session for the abdomen, flanks or both 8 weeks after the first session. 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.
Percentage of Participants Who Reported "Satisfied" or "Very Satisfied" on Cryolipolysis Satisfaction Questionnaire (CSQ) Item #1 Overall	89.6 percentage of participants Interval 83.8 to 95.4	—

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	CoolSculpting® System n=106 Participants 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.	CoolSculpting®: Treatment Session 2 Participants who received a second CoolSculpting® treatment session for the abdomen, flanks or both 8 weeks after the first session. 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.
Percentage of Participants Who Reported "Satisfied" or "Very Satisfied" on CSQ Item #1 in Treated Area(s) Abdomen	87.1 percentage of participants Interval 80.6 to 93.7	—
Percentage of Participants Who Reported "Satisfied" or "Very Satisfied" on CSQ Item #1 in Treated Area(s) Flanks	93.1 percentage of participants Interval 88.1 to 98.0	—
Percentage of Participants Who Reported "Satisfied" or "Very Satisfied" on CSQ Item #1 in Treated Area(s) Abdomen and Flanks	89.6 percentage of participants Interval 83.5 to 95.7	—

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	CoolSculpting® System n=106 Participants 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.	CoolSculpting®: Treatment Session 2 Participants who received a second CoolSculpting® treatment session for the abdomen, flanks or both 8 weeks after the first session. 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.
Percentage of Participants Who Received 1 or 2 Treatments Who Reported "Satisfied" or "Very Satisfied" on CSQ Item #1 by Number of Treatment Cycles 24 Treatment Cycles	92.2 percentage of participants Interval 84.8 to 99.5	—
Percentage of Participants Who Received 1 or 2 Treatments Who Reported "Satisfied" or "Very Satisfied" on CSQ Item #1 by Number of Treatment Cycles 22 Treatment Cycles	100.0 percentage of participants Interval 100.0 to 100.0	—
Percentage of Participants Who Received 1 or 2 Treatments Who Reported "Satisfied" or "Very Satisfied" on CSQ Item #1 by Number of Treatment Cycles 21 Treatment Cycles	100.0 percentage of participants Interval 100.0 to 100.0	—
Percentage of Participants Who Received 1 or 2 Treatments Who Reported "Satisfied" or "Very Satisfied" on CSQ Item #1 by Number of Treatment Cycles 20 Treatment Cycles	100.0 percentage of participants Interval 100.0 to 100.0	—
Percentage of Participants Who Received 1 or 2 Treatments Who Reported "Satisfied" or "Very Satisfied" on CSQ Item #1 by Number of Treatment Cycles 18 Treatment Cycles	80.0 percentage of participants Interval 44.9 to 100.0	—
Percentage of Participants Who Received 1 or 2 Treatments Who Reported "Satisfied" or "Very Satisfied" on CSQ Item #1 by Number of Treatment Cycles 17 Treatment Cycles	100.0 percentage of participants Interval 100.0 to 100.0	—
Percentage of Participants Who Received 1 or 2 Treatments Who Reported "Satisfied" or "Very Satisfied" on CSQ Item #1 by Number of Treatment Cycles 16 Treatment Cycles	92.3 percentage of participants Interval 77.8 to 100.0	—
Percentage of Participants Who Received 1 or 2 Treatments Who Reported "Satisfied" or "Very Satisfied" on CSQ Item #1 by Number of Treatment Cycles 15 Treatment Cycles	100.0 percentage of participants Interval 100.0 to 100.0	—
Percentage of Participants Who Received 1 or 2 Treatments Who Reported "Satisfied" or "Very Satisfied" on CSQ Item #1 by Number of Treatment Cycles 14 Treatment Cycles	66.7 percentage of participants Interval 28.9 to 100.0	—
Percentage of Participants Who Received 1 or 2 Treatments Who Reported "Satisfied" or "Very Satisfied" on CSQ Item #1 by Number of Treatment Cycles 13 Treatment Cycles	100.0 percentage of participants Interval 100.0 to 100.0	—
Percentage of Participants Who Received 1 or 2 Treatments Who Reported "Satisfied" or "Very Satisfied" on CSQ Item #1 by Number of Treatment Cycles 12 Treatment Cycles	80.0 percentage of participants Interval 55.2 to 100.0	—
Percentage of Participants Who Received 1 or 2 Treatments Who Reported "Satisfied" or "Very Satisfied" on CSQ Item #1 by Number of Treatment Cycles 11 Treatment Cycles	100.0 percentage of participants Interval 100.0 to 100.0	—
Percentage of Participants Who Received 1 or 2 Treatments Who Reported "Satisfied" or "Very Satisfied" on CSQ Item #1 by Number of Treatment Cycles 10 Treatment Cycles	100.0 percentage of participants Interval 100.0 to 100.0	—
Percentage of Participants Who Received 1 or 2 Treatments Who Reported "Satisfied" or "Very Satisfied" on CSQ Item #1 by Number of Treatment Cycles 9 Treatment Cycles	100.0 percentage of participants Interval 100.0 to 100.0	—
Percentage of Participants Who Received 1 or 2 Treatments Who Reported "Satisfied" or "Very Satisfied" on CSQ Item #1 by Number of Treatment Cycles 7 Treatment Cycles	0 percentage of participants Interval 0.0 to 0.0	—
Percentage of Participants Who Received 1 or 2 Treatments Who Reported "Satisfied" or "Very Satisfied" on CSQ Item #1 by Number of Treatment Cycles 6 Treatment Cycles	100.0 percentage of participants Interval 100.0 to 100.0	—
Percentage of Participants Who Received 1 or 2 Treatments Who Reported "Satisfied" or "Very Satisfied" on CSQ Item #1 by Number of Treatment Cycles 5 Treatment Cycles	100.0 percentage of participants Interval 100.0 to 100.0	—
Percentage of Participants Who Received 1 or 2 Treatments Who Reported "Satisfied" or "Very Satisfied" on CSQ Item #1 by Number of Treatment Cycles 2 Treatment Cycles	100.0 percentage of participants Interval 100.0 to 100.0	—

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	CoolSculpting® System n=106 Participants 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.	CoolSculpting®: Treatment Session 2 Participants who received a second CoolSculpting® treatment session for the abdomen, flanks or both 8 weeks after the first session. 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.
Percentage of Participants by Body Mass Index (BMI) Categories Who Reported "Satisfied" or "Very Satisfied" on CSQ Item #1 BMI 18.5 - < 25	88.5 percentage of participants Interval 79.8 to 97.1	—
Percentage of Participants by Body Mass Index (BMI) Categories Who Reported "Satisfied" or "Very Satisfied" on CSQ Item #1 BMI 25 - ≤ 30	90.7 percentage of participants Interval 83.0 to 98.5	—

SECONDARY outcome

Timeframe: Baseline to 8 Weeks post-Treatment 1 and 12 Weeks post-Final Treatment 2

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).

Outcome measures

Outcome measures
Measure	CoolSculpting® System n=106 Participants 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.	CoolSculpting®: Treatment Session 2 Participants who received a second CoolSculpting® treatment session for the abdomen, flanks or both 8 weeks after the first session. 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.
Change From Baseline in Volume of Fat as Measured by 3 Dimensional (3D) Photography Change from Baseline at 8 Weeks Post-Treatment Session 1	-149.1 mL Standard Deviation 280.61	—
Change From Baseline in Volume of Fat as Measured by 3 Dimensional (3D) Photography Change from Baseline at 12 Weeks Post-Final Treatment	-264.8 mL Standard Deviation 411.36	—

SECONDARY outcome

Timeframe: 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)

Population: Safety Population included all participants who had at least 1 of the treatment procedures conducted.

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.

Outcome measures

Outcome measures
Measure	CoolSculpting® System n=112 Participants 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.	CoolSculpting®: Treatment Session 2 n=107 Participants Participants who received a second CoolSculpting® treatment session for the abdomen, flanks or both 8 weeks after the first session. 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.
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) TEAE	14.3 percentage of participants	10.3 percentage of participants
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) SAE	0.0 percentage of participants	0.9 percentage of participants

SECONDARY outcome

Timeframe: 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)

Population: Safety Population included all participants who had at least 1 of the treatment procedures conducted.

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.

Outcome measures

Outcome measures
Measure	CoolSculpting® System n=112 Participants 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.	CoolSculpting®: Treatment Session 2 n=107 Participants Participants who received a second CoolSculpting® treatment session for the abdomen, flanks or both 8 weeks after the first session. 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.
Percentage of Participants With Adverse Device Effects (ADEs) and Serious Adverse Device Effects (SADEs) ADE	14.3 percentage of participants	9.3 percentage of participants
Percentage of Participants With Adverse Device Effects (ADEs) and Serious Adverse Device Effects (SADEs) SADE	0 percentage of participants	0 percentage of participants

Adverse Events

CoolSculpting®: Treatment Session 1

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

CoolSculpting®: Treatment Session 2

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CoolSculpting®: Treatment Session 1 n=112 participants at risk Participants who received one CoolSculpting® treatment session for the abdomen, flanks or both. 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.	CoolSculpting®: Treatment Session 2 n=107 participants at risk Participants who received a second CoolSculpting® treatment session for the abdomen, flanks or both 8 weeks after the first session. 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.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/83 • 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) Safety Population included all participants who had at least 1 of the treatment procedures conducted. AEs are reported separately for each of the two treatment sessions.	1.3% 1/79 • 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) Safety Population included all participants who had at least 1 of the treatment procedures conducted. AEs are reported separately for each of the two treatment sessions.

Other adverse events

Other adverse events
Measure	CoolSculpting®: Treatment Session 1 n=112 participants at risk Participants who received one CoolSculpting® treatment session for the abdomen, flanks or both. 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.	CoolSculpting®: Treatment Session 2 n=107 participants at risk Participants who received a second CoolSculpting® treatment session for the abdomen, flanks or both 8 weeks after the first session. 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.
Skin and subcutaneous tissue disorders Pruritus	8.9% 10/112 • 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) Safety Population included all participants who had at least 1 of the treatment procedures conducted. AEs are reported separately for each of the two treatment sessions.	0.93% 1/107 • 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) Safety Population included all participants who had at least 1 of the treatment procedures conducted. AEs are reported separately for each of the two treatment sessions.

Additional Information

Therapeutic Area, Head

Allergan

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Publication restrictions are in place

Restriction type: OTHER