Patients Treated With VaserShape MC1NCT01373827
Protocol To Evaluate Patient Measurements After Ultrasonic Treatment
An observational study of Patients Treated With VaserShape MC1, run by Sound Surgical Technologies, LLC. at 1 site in United States.
Trial summary
Patients enrolled in this study will come from the Investigator's patient population and be ordinarily suitable for treatment using the MC1 device. The treatment they receive will be no different if they participate than if they do not. 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
- Patients Treated With VaserShape MC1
- What is being tested?
- VASERShape MC1
- Type of treatment
- Medical device
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Mar 2012
- 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: All subjects presenting to the investigator for treatment using the MC1 are potential study candidates and will be screened for eligibility. Every effort will be made to establish eligibility of the participants before enrollment. Subjects who do not meet all inclusion/exclusion criteria will not be enrolled. Enrollment in the study occurs at the time the patient is randomized to the assigned treatment.
Who may be able to join
- Healthy Female 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 posterior thigh / saddlebag area using the MC1.
- Has never been treated with the MC1 before.
- Females who are post menopausal or using a medically acceptable form of birth control prior to study enrollment and during the course of the study. (i.e., condoms with spermicide, oral contraceptives contraceptive implants etc.)
Who cannot join
- Subject is lactating, has a positive pregnancy test within 7 days of planned study procedure (for female subjects of child-bearing potential), or intends to become pregnant during the study.
- 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, hypertorphic scars or a history of abnormal healing.
- Any known bruising disorder, anticoagulative / thromboembolic condition , hemorrhagic (bleeding) status or use of anti coagulants.
- Tissue ischemia in the area to be treated.
- Suffering from concurrent conditions such as liver or kidney disorders, Hypertension or abnormally high blood pressure.
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- High cholesterol and/or diabetes.
- Active collagen vascular disease (e.g. fibromyalgia, panniculitis, lupus etc.).
- Epilepsy.
- Tuberculosis.
- Auxiliary electric organs (such as pacemakers), metal or myoelectric prosthesis.
- Suffering from Endocrine syndromes or thyroid hyperfunction.
- 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).
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Laser & Skin Surgery Center of New York
New York, New York, 10016
About this study
Official title: Protocol To Evaluate Patient Measurements After Ultrasonic Treatment.
Patients enrolled in this study will come from the Investigator's patient population and be ordinarily suitable for treatment using the MC1 device. The treatment they receive will be no different if they participate than if they do not. The study is only to observe the patients before, during and after their usual treatment.
- Conditions
- Patients Treated With VaserShape MC1
- Being tested
- VASERShape MC1
- Keywords
- VASER, VASERShape, MC1, ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VASERShape MC1Device
Use of the VASERShape MC1 device as part of routine practice
| Study group | Role | What they receive |
|---|---|---|
| MC1 Subjects | Not described Receives: Device: VASERShape MC1 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Treated With VaserShape MC1Studies 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sound Surgical Technologies, LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01373827
- Sponsor's protocol ID
- SST2011-2
- Status last verified
- Mar 2012
- First submitted
- 14 Jun 2011
- Last updated
- 26 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2012. 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
- NCT01373827
- Acronym / sponsor ID
- SST2011-2
- Conditions
- Patients Treated With VaserShape MC1
- Keywords
- VASER, VASERShape, MC1, ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Sound Surgical Technologies, LLC.Industry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 15 Jun 2011 (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.
Patients enrolled in this study will come from the Investigator's patient population and be ordinarily suitable for treatment using the MC1 device. The treatment they receive will be no different if they participate than if they do not. The study is only to observe the patients before, during and after their usual treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MC1 Subjects | – | Device: VASERShape MC1 |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All subjects presenting to the investigator for treatment using the MC1 are potential study candidates and will be screened for eligibility. Every effort will be made to establish eligibility of the participants before enrollment. Subjects who do not meet all inclusion/exclusion criteria will not be enrolled. Enrollment in the study occurs at the time the patient is randomized to the assigned treatment.
Key inclusion criteria (5 listed)
- Healthy Female 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 posterior thigh / saddlebag area using the MC1.
- Has never been treated with the MC1 before.
- Females who are post menopausal or using a medically acceptable form of birth control prior to study enrollment and during the course of the study. (i.e., condoms with spermicide, oral contraceptives contraceptive implants etc.)
Key exclusion criteria (16 listed)
- Subject is lactating, has a positive pregnancy test within 7 days of planned study procedure (for female subjects of child-bearing potential), or intends to become pregnant during the study.
- 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, hypertorphic scars or a history of abnormal healing.
- Any known bruising disorder, anticoagulative / thromboembolic condition , hemorrhagic (bleeding) status or use of anti coagulants.
- Tissue ischemia 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 |
|---|---|---|
| VASERShape MC1Use of the VASERShape MC1 device as part of routine practice | Device | MC1 Subjects |
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 26 Mar 2012.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Patients Treated With VaserShape 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 16 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 26 Mar 2012. 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 26 Mar 2012.