NCT01993238

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
4 months until next milestone

Results Posted

Study results publicly available

April 29, 2014

Completed
Last Updated

April 29, 2014

Status Verified

March 1, 2014

Enrollment Period

2 months

First QC Date

November 11, 2013

Results QC Date

March 25, 2014

Last Update Submit

March 25, 2014

Conditions

Body Contouring

Outcome Measures

Primary Outcomes (1)

  • 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)

    Baseline

Secondary Outcomes (2)

  • Safety Assessment

    Baseline, 1 day, 1 week

  • Pain Scores Reported at 1-day Post-Treatment

    1 day

Study Arms (1)

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)

Device: Liposonix System (Model 2)Drug: Pre-treatment analgesia

Interventions

Liposonix System (Model 2)DEVICE

Treatment of subcutaneous adipose tissue of the abdomen using high intensity focused ultrasound (Liposonix System Model 2).

Liposonix with pre-treatment analgesia
Pre-treatment analgesiaDRUG

Pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)

Liposonix with pre-treatment analgesia

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Solta Medical Aesthetic Center

Hayward, California, 94545, United States

Location

Results Point of Contact

Title
Director of Clinical Programs
Organization
Solta Medical
aloncaric@solta.com
510-259-5284

Study Officials

  • Ronald Wheeland, MD

    PRINCIPAL INVESTIGATOR

  • Reid Rubsamen, MD

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2013

First Posted

November 25, 2013

Study Start

November 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

April 29, 2014

Results First Posted

April 29, 2014

Record last verified: 2014-03

Locations

US(1)