Trial Outcomes & Findings for Evaluation of Procedural Analgesia for Liposonix Treatment (NCT NCT01993238)

NCT ID: NCT01993238

Last Updated: 2014-04-29

Results Overview

Following treatment, the subject was asked to evaluate the pain level for the overall treatment using the 0-10 Visual Analog Scale (0 represents no pain and 10 represents worst imaginable pain)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 11 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2014-04-29

Participant Flow

Participant milestones

Measure	Liposonix With Pre-treatment Analgesia Liposonix System (Model 2) treatment of subcutaneous adipose tissue with pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone) Liposonix System (Model 2): Treatment of subcutaneous adipose tissue of the abdomen using high intensity focused ultrasound (Liposonix System Model 2). Pre-treatment analgesia: Pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Procedural Analgesia for Liposonix Treatment

Baseline characteristics by cohort

Measure	Liposonix With Pre-treatment Analgesia n=11 Participants Liposonix System (Model 2) treatment of subcutaneous adipose tissue with pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone) Liposonix System (Model 2): Treatment of subcutaneous adipose tissue of the abdomen using high intensity focused ultrasound (Liposonix System Model 2). Pre-treatment analgesia: Pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)
Age, Continuous	35.9 years STANDARD_DEVIATION 11.2 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Intent to Treat

Following treatment, the subject was asked to evaluate the pain level for the overall treatment using the 0-10 Visual Analog Scale (0 represents no pain and 10 represents worst imaginable pain)

Outcome measures

Measure

Liposonix With Pre-treatment Analgesia n=11 Participants Liposonix System (Model 2) treatment of subcutaneous adipose tissue with pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone) Liposonix System (Model 2): Treatment of subcutaneous adipose tissue of the abdomen using high intensity focused ultrasound (Liposonix System Model 2). Pre-treatment analgesia: Pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)

Pain Score for Overall Treatment

6.3 units on a scale Standard Deviation 2.2

SECONDARY outcome

Timeframe: Baseline, 1 day, 1 week

Adverse events will be assessed and documented throughout the study

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 day

Population: Intent-to-Treat

During the 1-day follow-up phone call, subjects were asked to rate the pain they were currently experiencing from the Liposonix treatment using a 0-10 pain scale (0 represents no pain and 10 represents worst pain imaginable).

Outcome measures

Measure

Liposonix With Pre-treatment Analgesia n=11 Participants Liposonix System (Model 2) treatment of subcutaneous adipose tissue with pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone) Liposonix System (Model 2): Treatment of subcutaneous adipose tissue of the abdomen using high intensity focused ultrasound (Liposonix System Model 2). Pre-treatment analgesia: Pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)

Pain Scores Reported at 1-day Post-Treatment

2.1 units on a scale Standard Deviation 2.6

Adverse Events

Liposonix With Pre-treatment Analgesia

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure

Liposonix With Pre-treatment Analgesia n=11 participants at risk Liposonix System (Model 2) treatment of subcutaneous adipose tissue with pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone) Liposonix System (Model 2): Treatment of subcutaneous adipose tissue of the abdomen using high intensity focused ultrasound (Liposonix System Model 2). Pre-treatment analgesia: Pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)

Musculoskeletal and connective tissue disorders Car Accident

9.1% 1/11 • Number of events 1 • Adverse event data were collected from day 0 through study follow-up (1 week post-treatment)

Other adverse events

Measure	Liposonix With Pre-treatment Analgesia n=11 participants at risk Liposonix System (Model 2) treatment of subcutaneous adipose tissue with pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone) Liposonix System (Model 2): Treatment of subcutaneous adipose tissue of the abdomen using high intensity focused ultrasound (Liposonix System Model 2). Pre-treatment analgesia: Pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)
General disorders Pain during treatment	100.0% 11/11 • Number of events 11 • Adverse event data were collected from day 0 through study follow-up (1 week post-treatment)
Skin and subcutaneous tissue disorders Ecchymosis	90.9% 10/11 • Number of events 10 • Adverse event data were collected from day 0 through study follow-up (1 week post-treatment)
Skin and subcutaneous tissue disorders Erythema	100.0% 11/11 • Number of events 11 • Adverse event data were collected from day 0 through study follow-up (1 week post-treatment)
Skin and subcutaneous tissue disorders Tenderness	45.5% 5/11 • Number of events 5 • Adverse event data were collected from day 0 through study follow-up (1 week post-treatment)
Skin and subcutaneous tissue disorders Soreness	45.5% 5/11 • Number of events 5 • Adverse event data were collected from day 0 through study follow-up (1 week post-treatment)
Skin and subcutaneous tissue disorders Tingling/Altered Sensation	45.5% 5/11 • Number of events 5 • Adverse event data were collected from day 0 through study follow-up (1 week post-treatment)
Skin and subcutaneous tissue disorders Edema	27.3% 3/11 • Number of events 3 • Adverse event data were collected from day 0 through study follow-up (1 week post-treatment)
General disorders Nausea/Vomiting	27.3% 3/11 • Number of events 3 • Adverse event data were collected from day 0 through study follow-up (1 week post-treatment)
General disorders Dizziness/Feeling Faint	18.2% 2/11 • Number of events 2 • Adverse event data were collected from day 0 through study follow-up (1 week post-treatment)
Skin and subcutaneous tissue disorders Warm sensation on treatment area	18.2% 2/11 • Number of events 2 • Adverse event data were collected from day 0 through study follow-up (1 week post-treatment)
Skin and subcutaneous tissue disorders Surface sensitivity/soreness at treatment site	18.2% 2/11 • Number of events 2 • Adverse event data were collected from day 0 through study follow-up (1 week post-treatment)
General disorders Tiredness	9.1% 1/11 • Number of events 1 • Adverse event data were collected from day 0 through study follow-up (1 week post-treatment)
General disorders Headache	18.2% 2/11 • Number of events 2 • Adverse event data were collected from day 0 through study follow-up (1 week post-treatment)
Skin and subcutaneous tissue disorders Itching	9.1% 1/11 • Number of events 1 • Adverse event data were collected from day 0 through study follow-up (1 week post-treatment)
General disorders Feeling cold	9.1% 1/11 • Number of events 1 • Adverse event data were collected from day 0 through study follow-up (1 week post-treatment)
Skin and subcutaneous tissue disorders Bruising at attempted IV site	9.1% 1/11 • Number of events 1 • Adverse event data were collected from day 0 through study follow-up (1 week post-treatment)
Skin and subcutaneous tissue disorders Burning sensation to touch	9.1% 1/11 • Number of events 1 • Adverse event data were collected from day 0 through study follow-up (1 week post-treatment)
General disorders Pain with movement	9.1% 1/11 • Number of events 1 • Adverse event data were collected from day 0 through study follow-up (1 week post-treatment)
General disorders Sense of pressure at treatment site	9.1% 1/11 • Number of events 1 • Adverse event data were collected from day 0 through study follow-up (1 week post-treatment)
General disorders Flu-like symptoms	9.1% 1/11 • Number of events 1 • Adverse event data were collected from day 0 through study follow-up (1 week post-treatment)

Additional Information

Director of Clinical Programs

Solta Medical

Phone: 510-259-5284

Email: aloncaric@solta.com

Results disclosure agreements

• Principal investigator is a sponsor employee Investigator shall notify Sponsor of the intent to publish or present independent Study Data, and agrees not to publish or publicly present and/or discuss such data, Investigator's current findings and/or the results of the Study independently without the express written consent of Sponsor, which consent may be withheld. Prior to submission for publication or presentation, all draft manuscripts must be submitted, reviewed and approved by Sponsor for confidential material.
• Publication restrictions are in place

Restriction type: OTHER