Females Scheduled to be Treated Using the MC1.NCT01260298
Protocol To Evaluate Patient Measurements After Ultrasonic Treatment
An observational study of Females Scheduled to be Treated Using the MC1., run by Sound Surgical Technologies, LLC. at 1 site in United States.
Trial summary
The objective of this study is to observe body contour changes following treatment using the MC1 device. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Females Scheduled to be Treated Using the MC1.
- What is being tested?
- MC1 Ultrasonic Device
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Mar 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Female between the ages of 20 and 50 years with BMI between 20 and 30 who are scheduled to be treated using the MC1 device.
Who may be able to join
- Is female.
- Is between 20 and 50 years of age, inclusive, on the day of enrolment.
- Has a BMI between 20 and 30 kg/m2.
- Is to be treated in the infra-scapular area using the MC1.
- Has never been treated with the MC1 before.
Who cannot join
- Patient is lactating, has a positive pregnancy test within 7 days of planned study procedure (for female patients of child-bearing potential), or intends to become pregnant during the study or is not using effective methods to prevent pregnancy.
- Currently enrolled in another device or drug study that has not completed the required follow-up period, or has completed all other study-required follow-up less than 30 days before enrolment in this study.
- Keloid scars, hypertrophic scars or a history of abnormal healing.
- Thrombophlebitis.
- Bleeding or bruising disorders (e.g. idiopathic thrombocytopenic purpura, anticoagulated patients).
- Tissue ischemia in the area to be treated.
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- Hypertension or abnormally high blood pressure.
- High cholesterol.
- Active collagen vascular disease (e.g. fibromyalgia, panniculitis, lupus etc.).
- Diabetes.
- Epilepsy.
- Tuberculosis.
- Auxiliary electric organs (such as pacemakers), metal or myoelectric prosthesis.
- Endocrine syndromes or thyroid hyperfunction.
- Any type of hemorrhagic (bleeding) status.
- Active skin infection, any infection in the treated area within the last 30 days or skin disease in the area to be treated (e.g. eczema, psoriasis, urticaria, dermographism).
- Hepatic or renal insufficiency.
- Bone, muscle or joint disease, dysfunction or healing in the area to be treated.
- Malignancy in the area to be treated.
- Laminectomy in the area to be treated. 5.2. Withdrawal and Replacement of Subjects
Trial locations and contacts
1 site in 1 country.
United States1 site
Skin Care Physicians
Chestnut Hill, Massachusetts, 02467
About this study
Official title: Protocol To Evaluate Patient Measurements After Ultrasonic Treatment.
The objective of this study is to observe body contour changes following treatment using the MC1 device.
Read the detailed description
The purpose of this research study is to observe body contour changes following treatment using the MC1 device. The MC1 System is FDA cleared for relief of minor muscle aches, pain and muscle spasm, temporary improvement in local blood circulation, and temporary reduction in the appearance of cellulite.
- Being tested
- MC1 Ultrasonic Device
- Keywords
- MC1 VASER VASERShape
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MC1 Ultrasonic DeviceDevice
Also called MC1, VASERShape
Ultrasonic and zonal massage device.
| Study group | Role | What they receive |
|---|---|---|
| MC1 Ultrasonic Device | Not described Receives: Device: MC1 Ultrasonic Device |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Females Scheduled to be Treated Using the MC1.Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sound Surgical Technologies, LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael Kaminer, MD, Principal investigator, SkinCare Physicians
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01260298
- Sponsor's protocol ID
- SST2010-2
- Status last verified
- Mar 2011
- First submitted
- 13 Dec 2010
- Last updated
- 11 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol To Evaluate Patient Measurements After Ultrasonic Treatment.
- ClinicalTrials.gov ID
- NCT01260298
- Acronym / sponsor ID
- SST2010-2
- Keywords
- MC1 VASER VASERShape
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Sound Surgical Technologies, LLC.Industry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 15 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to observe body contour changes following treatment using the MC1 device.
Detailed description
The purpose of this research study is to observe body contour changes following treatment using the MC1 device. The MC1 System is FDA cleared for relief of minor muscle aches, pain and muscle spasm, temporary improvement in local blood circulation, and temporary reduction in the appearance of cellulite.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MC1 Ultrasonic Device | – | Device: MC1 Ultrasonic Device |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Female between the ages of 20 and 50 years with BMI between 20 and 30 who are scheduled to be treated using the MC1 device.
Key inclusion criteria (5 listed)
- Is female.
- Is between 20 and 50 years of age, inclusive, on the day of enrolment.
- Has a BMI between 20 and 30 kg/m2.
- Is to be treated in the infra-scapular area using the MC1.
- Has never been treated with the MC1 before.
Key exclusion criteria (20 listed)
- Patient is lactating, has a positive pregnancy test within 7 days of planned study procedure (for female patients of child-bearing potential), or intends to become pregnant during the study or is not using effective methods to prevent pregnancy.
- Currently enrolled in another device or drug study that has not completed the required follow-up period, or has completed all other study-required follow-up less than 30 days before enrolment in this study.
- Keloid scars, hypertrophic scars or a history of abnormal healing.
- Thrombophlebitis.
- Bleeding or bruising disorders (e.g. idiopathic thrombocytopenic purpura, anticoagulated patients).
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 |
|---|---|---|
| MC1 Ultrasonic DeviceAlso: MC1, VASERShapeUltrasonic and zonal massage device. | Device | MC1 Ultrasonic Device |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2011.
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.
Michael Kaminer, MD principal investigator
SkinCare Physicians
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Females Scheduled to be Treated Using the MC1., run by Sound Surgical Technologies, LLC. 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 11 Mar 2011. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
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 11 Mar 2011.