Body ContouringNCT01993238

Evaluation of Procedural Analgesia for Liposonix Treatment

A study testing Liposonix System (Model 2) and Pre-treatment analgesia in people with Body Contouring, run by Solta Medical at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objectives of this study are to evaluate the safety and effectiveness of procedural analgesia for improvements in tolerability of treatment with the Liposonix System. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Body Contouring
What is being tested?: Liposonix System (Model 2) and Pre-treatment analgesia
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 1 siteUnited States
Study dates: Nov 2013to Jan 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subject is an adult female or male, 18 to 65 years of age.
Subject must weigh more than 120 pounds.
Subject must have a Body Mass Index of ≤ 30 kg/m2.
Subject must have thickness of skin + subcutaneous adipose tissue in the anticipated treatment area of ≥ 2.3 cm.
Subject must be able to read, write, speak, and understand English.

Who cannot join

Female subject who is pregnant, is suspected to be pregnant, or is lactating
Subjects diagnosed with coagulation disorders or are receiving anticoagulant therapy or medications or dietary supplements which impede coagulation or platelet aggregation
Subject has diabetes or cardiovascular disease
Subject has had any aesthetic procedure to the region to be treated within past 6 months
Subject has systemic skin disease or skin disease in the area to be treated
Subject has any abnormality of the skin or soft tissues of the abdominal wall in the area to be treated

Show all 20Show fewer

Subject has had previous open or laparoscopic surgery in the anticipated treatment area
Subjects is on prescription or over the counter weight reduction medication or programs, or had weight reduction procedures
Subject has skin or superficial tissue that does not lie flat on its own when the subject is in the supine position
Subjects undergoing chronic steroid or immunosuppressive therapy
Subjects who have cardiac pacemakers or any implantable electrical device
Subjects who have metal implants of any type in the area to be treated
History of cancer
Subjects who have sensory loss or dysesthesia in the area to be treated
Subjects taking chronic benzodiazepines or opiates
Subjects with a history of severe nausea/vomiting with opioid analgesics
Subjects with sleep apnea
Subjects with known allergies or sensitivities to study drugs
Subjects with liver disease
Subjects with renal failure

Trial locations and contacts

1 site in 1 country.

United States1 site

Solta Medical Aesthetic Center
Hayward, California, 94545

Other trials in United States

About this study

Official title: An Evaluation of Procedural Analgesia for Out-Patient Liposonix Treatment

The objectives of this study are to evaluate the safety and effectiveness of procedural analgesia for improvements in tolerability of treatment with the Liposonix System.

Conditions: Body Contouring
Being tested: Liposonix System (Model 2), Pre-treatment analgesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Liposonix System (Model 2)Device
Treatment of subcutaneous adipose tissue of the abdomen using high intensity focused ultrasound (Liposonix System Model 2).
Pre-treatment analgesiaDrug
Pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)

Study groups in NCT01993238
Study group	Role	What they receive
Liposonix with pre-treatment analgesia	Experimental	Liposonix System (Model 2) treatment of subcutaneous adipose tissue with pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone) Receives: Device: Liposonix System (Model 2); Drug: Pre-treatment analgesia

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain Score for Overall Treatment
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)
Measured: Baseline

Secondary outcomes (2)

Safety Assessment
Adverse events will be assessed and documented throughout the study
Measured: Baseline, 1 day, 1 week
Pain Scores Reported at 1-day Post-Treatment
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).
Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2013Jan 2014

First posted25 Nov 2013 (estimated)
Study startNov 2013
Primary completionJan 2014
Study completionJan 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Body ContouringStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01993238
Sponsor's protocol ID: 13-140-LP-H
Status last verified: Mar 2014
First submitted: 11 Nov 2013
Last updated: 29 Apr 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 29 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Evaluation of Procedural Analgesia for Out-Patient Liposonix Treatment
ClinicalTrials.gov ID: NCT01993238
Acronym / sponsor ID: 13-140-LP-H
Conditions: Body Contouring
Study type: Interventional
Recruitment status: Completed
Enrolment: 11 participants (actual)
Lead sponsor: Solta MedicalIndustry (pharma, biotech, devices)
Study start: Nov 2013
Primary completion: Jan 2014 (actual)
Study completion: Jan 2014 (actual)
First posted: 25 Nov 2013 (estimated)
Results: Posted 29 Apr 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The objectives of this study are to evaluate the safety and effectiveness of procedural analgesia for improvements in tolerability of treatment with the Liposonix System.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Liposonix with pre-treatment analgesia	Experimental	Device: Liposonix System (Model 2), Drug: Pre-treatment analgesiaLiposonix System (Model 2) treatment of subcutaneous adipose tissue with pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Subject is an adult female or male, 18 to 65 years of age.
Subject must weigh more than 120 pounds.
Subject must have a Body Mass Index of ≤ 30 kg/m2.
Subject must have thickness of skin + subcutaneous adipose tissue in the anticipated treatment area of ≥ 2.3 cm.
Subject must be able to read, write, speak, and understand English.

Key exclusion criteria (20 listed)

Female subject who is pregnant, is suspected to be pregnant, or is lactating
Subjects diagnosed with coagulation disorders or are receiving anticoagulant therapy or medications or dietary supplements which impede coagulation or platelet aggregation
Subject has diabetes or cardiovascular disease
Subject has had any aesthetic procedure to the region to be treated within past 6 months
Subject has systemic skin disease or skin disease in the area to be treated

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Liposonix System (Model 2)Treatment of subcutaneous adipose tissue of the abdomen using high intensity focused ultrasound (Liposonix System Model 2).	Device	Liposonix with pre-treatment analgesia
Pre-treatment analgesiaPre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)	Drug	Liposonix with pre-treatment analgesia

Primary outcome

Pain Score for Overall Treatment
Time frame: Baseline
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)

2 secondary outcomes

Safety Assessment
Time frame: Baseline, 1 day, 1 week
Pain Scores Reported at 1-day Post-Treatment
Time frame: 1 day

Results and safety

Results posted to the registry on 29 Apr 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Liposonix With Pre-treatment Analgesia	11	11

Primary outcome: Pain Score for Overall Treatment

Time frame: Baseline. Mean (Standard Deviation). Unit: units on a scale

Measure	Liposonix With Pre-treatment Analgesia n = 11
Value	6.3 (2.2)

Population analysed: Intent to Treat

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected from day 0 through study follow-up (1 week post-treatment). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Liposonix With Pre-treatment Analgesia	1 of 11 (9.1%)	11 of 11 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ronald Wheeland, MD principal investigator

Reid Rubsamen, MD principal investigator

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Liposonix System (Model 2) and Pre-treatment analgesia in people with Body Contouring, run by Solta Medical at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Score for Overall Treatment (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01993238.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2014.